Therapeutic Goods (Medicines Advisory Statements) Specification 2021

2  Commencement

(1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

• Commencement information
• Column 1 Column 2 Column 3
• Provisions Commencement Date/Details
• 1. The whole of this instrument 1 January 2022. 1 January 2022

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under subsection 3(5A) of the Therapeutic Goods Act 1989.

4  Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) current Poisons Standard;

(b) label;

(c) medicine;

(d) supply;

(e) therapeutic use.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

dermal use means application to the skin primarily for localised effect.

divided preparation means a preparation manufactured and packed as discrete pre-measured dosage units prior to supply, and includes tablets, capsules, cachets, single dose powders or single dose sachets of powders or granules.

dosage unit means an individual dose of a medicine for therapeutic use, and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules.

essential oils means:

 (a) products obtained from natural raw materials by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation; or

 (b) oils of equivalent composition to products mentioned in paragraph (a) that are derived through synthetic means; or

 (c) prepared mixtures of oils of equivalent composition to products mentioned in paragraph (a) that comprise a mixture of synthetic and natural components.

external, in relation to the use of a medicine, means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice.

internal use means administration:

 (a) orally, except for topical effect in the mouth; or

 (b) for absorption and the production of a systemic effect:

 (i) by way of a body orifice other than the mouth; or

 (ii) parenterally, other than by application to unbroken skin.

main label means:

 (a) where there are two or more labels or two or more portions of a single label—that label or portion of the label where the product name is more or most conspicuously shown; or

 (b) where the product name is equally conspicuous on two or more labels or portions of a label—each such label or portion.

medicine in a prescribed class means medicine included in a class of medicine prescribed by the Regulations for the purposes of paragraph 3(5)(ca) of the Act.

MRDD or maximum recommended daily dose means the maximum approved dose per day for a medicine used for its main indication in adults.

Regulations means the Therapeutic Goods Regulations 1990.

signal words, in relation to a substance included in a schedule to the current Poisons Standard, means the signal word or words as specified in subsection 5(4).

topical use means application of a substance for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.

5  Interpretation

References to substances

 (1) In this instrument, unless the contrary intention appears, a reference to a substance includes the following:

 (a) that substance prepared from natural sources or artificially;

 (b) if the substance is a plant (other than a plant included in Schedule 8 or 9 to the current Poisons Standard)—that plant or any part of that plant when packed or prepared for therapeutic use;

 (c) every salt, active principle or derivative of the substance, including esters and ethers, and every salt of such an active principle or derivative;

 (d) every alkaloid of the substance and every salt of such an alkaloid;

 (e) every stereoisomer of the substance and every salt of such a stereoisomer, other than where the stereoisomer is defined in the substance name (for example, dextromethorphan);

 (f) a preparation or admixture containing any proportion of the substance;

  but does not include:

 (g) a preparation or product included in Appendix A of the current Poisons Standard; or

 (h) a substance included in Appendix G of the current Poisons Standard at a concentration not exceeding the concentration specified in that Appendix in relation to the substance; or

 (i) any other substance included in Schedules 1 to 6 to the current Poisons Standard, at a concentration not exceeding 10 mg per litre or 10 mg per kilogram, unless that substance is also included in Schedule 7 or 8 to the current Poisons Standard.

References to concentration, strength or quantity of substances

 (2) In this instrument, unless the contrary intention appears, for a reference to a concentration, strength or quantity of a substance:

 (a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance; and

 (b) the expression “1%” means:

 (i) in the case of a liquid preparation, 1 gram of the substance per 100 mL of the preparation; or

 (ii) in the case of a solid or semi-solid preparation, 1 gram of the substance per 100 grams of the preparation; and

 (iii) any expression of greater or lesser percentages shall have a corresponding meaning.

References to symbols

(3) A reference in column 4 of the table in Schedule 1, to a symbol in column 2 of an item in the following table, has the meaning set out in column 3 of that item.

• Meaning of symbols
• Column 1 Column 2 Column 3
• Item Symbol Meaning
• 1 [c] Statements must be included at the beginning of the directions for use on the label
• 2 [f] Statements must be included on the label written:(a) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN”; and(b) in bold-face sanserif capital letters of uniform thickness; and(c) in letters at least four tenths the height of the letters used for the signal words; and(d) with no other statement written on the same line
• 3 [g] Statements, written in sanserif capital letters, must be included on the main label or as part of the directions for use

Signal words

 (4) The signal word or words for a substance included in a schedule to the current Poisons Standard mentioned in column 2 of an item in the following table, that is to be used for the purpose in column 3 of that item, are specified in column 4 of that item.

• Signal word or words for substances
• Column 1 Column 2 Column 3 Column 4
• Item Schedule to the current Poisons Standard Purpose Signal word or words
• 1 Schedule 2 for any purpose PHARMACY MEDICINE
• 2 Schedule 3 for any purpose PHARMACIST ONLY MEDICINE
• 3 Schedule 4 for human use PRESCRIPTION ONLY MEDICINE
• 4 Schedule 5 for any purpose CAUTION
• 5 Schedule 6 for any purpose POISON
• 6 Schedule 7 for any purpose DANGEROUS POISON
• 7 Schedule 8 for any purpose CONTROLLED DRUG

6  Application

  This instrument applies to a medicine that is a medicine in a prescribed class.

7  Medicines advisory statements

 (1) Subject to subsection (2), the advisory statements mentioned in column 4 of an item in the table in Schedule 1, are specified in relation to a medicine in a prescribed class that contains the substance described in column 2 of that item, in the circumstances set out in column 3 of that item, for the purposes of paragraph 3(5)(ca) of the Act.

Alternative statements

 (2) The following advisory statements are specified in relation to a medicine in a prescribed class for the purposes of paragraph 3(5)(ca) of the Act, as an alternative to the advisory statements specified in relation to the medicine by subsection (1):

 (a) the advisory statements specified by subsection (1) in relation to the medicine, as varied in a manner that does not change the intent of the advisory statements;

 (b) if more than one advisory statement is specified by subsection (1) in relation to the medicine—the advisory statements combined to form a simple sentence in a manner that does not change the intent of each advisory statement.

Note:  Unless otherwise specified in column 3 of the table in Schedule 1, the requirements only apply if the substance is included in the medicine as an active ingredient.

8  Transitional arrangements

 (1) In this section:

  former specification means the Therapeutic Goods (Medicines Advisory Statements) Specification 2019, as in force immediately before the commencement of this instrument.

  transition period means the period beginning on the commencement of this instrument and ending on 30 June 2023.

 (2) Despite the repeal of the former specification by this instrument, the former specification continues to apply for the duration of the transition period such that the advisory statements specified in the former specification may continue to be used on a label of a medicine in a prescribed class for the purposes of paragraph 3(5)(ca) of the Act, as an alternative to the advisory statements specified under section 7.

Note:  During the transition period, the label of a medicine may contain the applicable advisory statements specified by the former specification instead of the advisory statements specified by this instrument in relation to the medicine. However, once the transition period ceases, the label must contain the advisory statements specified by this instrument in relation to the medicine.

9  Repeals

  The Therapeutic Goods (Medicines Advisory Statements) Specification 2019 is repealed.

Schedule 1—Required Advisory Statements for Medicine Labels No. 6

Note: See section 7.

• Required Advisory Statements for Medicine Labels

• Column 1 Column 2 Column 3 Column 4

• Item Substances Circumstances Required Statements

• 1 Alclometasone When included in 3 to the current Poisons Standard  CAUTION - Do not use for children under 2 years old unless a doctor has told you to. Do not use in the eyes. Do not use for acne. Do not use under waterproof bandages unless a doctor has Schedule told you to. Do not use for more than 7 days unless a doctor has told you to.

• 2 Alimemazine (trimeprazine)Entry 1 of 2 In oral medicines that are NOT indicated for cough cold or flu, which include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)when NOT separately specified in this table - either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• and ( if 'x' < 12)- Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

• 3 Alimemazine (trimeprazine)Entry 2 of 2 In oral medicines that are NOT indicated for cough cold or flu, that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. Do not give to children between 'x' and ‘y’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner. If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

• 4 Alpha hydroxy acids, including:

• citric acid and other fruit acids

• glycollic acid

• lactic acid When used as active ingredients in preparations for topical use  This product may make your skin more sensitive to sunlight and other sources of UV light. Sun exposure should be limited by using a sunscreen and by wearing protective clothing. Transient stinging or irritation may occur when using this product. If irritation persists, discontinue use. If you have sensitive skin, test this product on a small area of skin before applying it to a large area. Not recommended for use on children and infants.

• 5 Amethocaine (tetracaine)(Entry 1 of 2) When included in Schedule 2 to the current Poisons Standard and for dermal use  Do not apply to large areas of the body, except on the advice of a healthcare practitioner. If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

• 6 Amethocaine (tetracaine)(Entry 2 of 2) For the purpose of exclusion from the schedules to the current Poisons Standard when in dermal preparations containing 2% OR LESS of total local anaesthetic substances  If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

• 7 Ammonia and ammonium salts, including

• ammonium chloride

• ammonium bicarbonate

• ammonium carbonate(Entry 1 of 2) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  Do not give to children under 12 years of age. If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 8 Ammonia and ammonium salts, including

• ammonium chloride

• ammonium bicarbonate

• ammonium carbonate(Entry 2 of 2) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 9 Anise oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 50% of anise oil; and

• packed in containers having a nominal capacity of 50 mL or less, fitted with a restricted flow insert  KEEP OUT OF REACH OF CHILDREN.

• 10 Antihistamines(Entry 1 of 5)including:

• Alimemazine (trimeprazine)

• Triprolidinewhen NOT separately specified in this table In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)when NOT separately specified in this table - either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• and ( if 'x' < 12)- Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. (for alimemazine and promethazine only) If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

• 11 Antihistamines(Entry 2 of 5)including:

• Alimemazine (trimeprazine)

• Triprolidinewhen NOT separately specified in this table In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)when NOT separately specified in this table  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. Do not give to children between 'x' and ‘y’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner. (for alimemazine and promethazine only) If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

• 12 Antihistamines(Entry 3 of 5)including:

• Triprolidinewhen NOT separately specified in this table In oral preparations indicated for COUGH, COLD OR FLU:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• (for promethazine only) If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

• 13 Antihistamines(Entry 4 of 5)including:

• Triprolidinewhen NOT separately specified in this table In oral preparations indicated for COUGH, COLD OR FLU:

• which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. (for promethazine only) If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

• 14 Antihistamines(Entry 5 of 5)including:

• Promethazine In oral medicines indicated for SHORT TERM USE IN INSOMNIA:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 2) (Note: Antihistamine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Antihistamines (Entry 2 of 5))  This product should be taken on medical or pharmacist advice. Do not give to children under ‘x’ years of age. If breastfeeding, consult a doctor or pharmacist before use. (for promethazine only) If pregnant or likely to become pregnant, consult a doctor or pharmacist before use. Do not take this medicine for more than a few days. This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.

• 15 Aspartame When for oral ingestion and included in medicines as an active or excipient ingredient  Phenylketonurics are warned that this product contains aspartame (phenylalanine).

• 16 Aspirin (Entry 1 of 3) When NOT in combination with other therapeutically active substances (other than effervescent agents), or indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation  Do not use if you have a stomach ulcer. Do not use if you are allergic to aspirin or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless a doctor has told you to, do not use in children under 12 years of age. Unless a doctor has told you to, do not use in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever. Unless advised by your doctor or pharmacist, do not use with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly. Do not use during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy. Unless a doctor has told you to, do not use for more than a few days at a time. See a doctor before taking for thinning the blood or for your heart.

• 17 Aspirin (Entry 2 of 3) When the preparation IS indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation  For use under medical supervision only. Do not use if you have a stomach ulcer. Do not use if you are allergic to aspirin or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless a doctor has told you to, do not use in children under 12 years of age. Unless a doctor has told you to, do not use in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever. Unless advised by your doctor or pharmacist, do not use with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly. Do not use during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy. See a doctor before taking for thinning the blood or for your heart.

• 18 Aspirin (Entry 3 of 3) When included in a schedule to the current Poisons Standard and in combination with other therapeutically active substances (other than effervescent agents)  Do not use if you have a stomach ulcer. Do not use if you are allergic to aspirin or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless a doctor has told you to, do not use in children under 12 years of age. Unless a doctor has told you to, do not use in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever. Unless advised by your doctor or pharmacist, do not use with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly. Do not use during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy. Unless a doctor has told you to, do not use for more than a few days at a time.

• 19 Atropa belladona In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness  If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

• 20 Atropine In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness  If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

• 21 Azadirachta indica (neem)(Entry 1 of 2) For the purpose of exclusion from the schedules to the current Poisons Standard when in preparations for dermal use and in a container fitted with a child resistant closure  Not to be taken. Keep out of reach of children. Do not use if pregnant or likely to become pregnant.

• 22 Azadirachta indica including its extracts and derivatives(Entry 2 of 2) When included in Schedule 6 to the current Poisons Standard - Do not use if pregnant or likely to become pregnant.

• 23 Azelastine In preparations for topical ophthalmic or nasal administration  If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.

• 24 Basil oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations or oils containing more than 5% of methyl chavicol; and

• packed in containers having a nominal capacity of 25 mL or less, fitted with a restricted flow insert  KEEP OUT OF REACH OF CHILDREN.

• 25 Bay oil For the purpose of exclusion from the schedules to the current Poisons Standard when: in preparations containing more than 25% of bay oil; and packed in containers having:- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or- a nominal capacity of 25 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 26 Benzocaine(Entry 1 of 4) In dermal preparations containing MORE than 2% of total local anaesthetic substances  Do not apply to large areas of the body, except on the advice of a healthcare practitioner. If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

• 27 Benzocaine(Entry 2 of 4) In dermal preparations containing 2% OR LESS of total local anaesthetic substances  If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

• 28 Benzocaine(Entry 3 of 4) In lozenges  Do not take hot food or drink if the mouth feels numb after taking this product as it may burn the mouth. Do not give to children under 6 years of age, unless recommended by a doctor, pharmacist or dentist.

• 29 Benzocaine(Entry 4 of 4) In preparations for topical oral use EXCEPT lozenges  Do not give to children under 2 years of age.

• 30 Benzoyl peroxide In Schedule 2 to the current Poisons Standard  Keep from eyes, lips, mouth and sensitive areas of the neck. If excessive swelling, irritation, redness or peeling occurs, discontinue use. If these persist, consult a physician. Avoid excessive exposure to sunlight and other sources of ultra violet light.

• 31 Benzydamine In preparations for topical use or dermal use  Do not use [this product/insert name of product] if you are allergic to benzydamine or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately.

• 32 Bergamot oil For the purpose of exclusion from the schedules to the current Poisons Standard; or when included in a schedule to the current Poisons Standard  Application to skin may increase sensitivity to sunlight.

• 33 Bromhexine (Entry 1 of 2) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  Do not give to children under 12 years of age. If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 34 Bromhexine(Entry 2 of 2) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 35 Brompheniramine(Entry 1 of 4) In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)when NOT separately specified in this table - either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• and ( if 'x' < 12)- Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 36 Brompheniramine(Entry 2 of 4) In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)when NOT separately specified in this table  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. Do not give to children between 'x' and ‘y’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 37 Brompheniramine(Entry 3 of 4) In oral preparations indicated for COUGH, COLD OR FLU:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 38 Brompheniramine(Entry 4 of 4) In oral preparations indicated for COUGH, COLD OR FLU:

• which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 39 Butoconazole In preparations for vaginal use  Do not use if you are pregnant. See a doctor before use if you are diabetic. Seek medical advice before first course of treatment. See a doctor if no better after [Insert number of days as per approved Product Information] days. See a doctor if problem returns.

• 40 Cajuput oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations or oils containing more than 25% of cajuput oil; and

• packed in containers having:- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or- a nominal capacity of 25 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 41 Camphor(Entry 1 of 3) For the purpose of exclusion from the schedules to the current Poisons Standard when:

• included as a natural component in essential oils containing greater than 2.5% of camphor but 10% or less of camphor; and

• packed in containers having a nominal capacity of 25 mL or less, fitted with a restricted flow insert  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN. Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist.

• 42 Camphor(Entry 2 of 3) For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in essential oils when the camphor is present as a natural component of the oil; and

• packed in containers having:- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or- a nominal capacity of 25 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN. Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist.

• 43 Camphor(Entry 3 of 3) When:

• included in a schedule to the current Poisons Standard, and

• not in block, ball or pellet form, enclosed in a device which, in normal use, prevents removal or ingestion of its contents.  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSCan be fatal to children if sucked or swallowed.Avoid contact with eyes.

• 44 Cassia oil When included in a schedule to the current Poisons Standard  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSAvoid contact with skin.

• DO NOT SWALLOW. [g]

• 45 Cetirizine(Entry 1 of 2) In preparations for oral use that are NOT specifically labelled for use only in children (between 1 year and 12 years of age)  either - This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.

• 46 Cetirizine(Entry 2 of 2) In preparations for oral use specifically labelled for use only in children (between 1 year and 12 years of age)  This medication may cause drowsiness.

• 47 Chelidonium majus When the preparation is for oral use  Warning: Greater Celandine may harm the liver in some people. Use only under the supervision of a healthcare professional.

• 48 Chloramphenicol In medicines for ophthalmic use  Contact lens wearers should not use this product except on the advice of a doctor or optometrist. If your eye infection does not improve within 48 hours, seek immediate medical advice. Do not use in children under 2 years of age except on medical advice.

• 49 Chlorhexidine(Entry 1 of 2) In preparations for topical use on mucosal surfaces. Note: If also for dermal use, Entry 2 below applies.  Avoid contact with eyes. If in eyes, rinse well with water. Chlorhexidine can cause severe allergic reactions. Seek immediate medical assistance if this occurs.

• 50 Chlorhexidine(Entry 2 of 2) In preparations for dermal use  Avoid contact with eyes. If in eyes, rinse well with water. Mild skin irritation may occur; stop use if it becomes more severe. Chlorhexidine can cause severe allergic reactions. Seek immediate medical assistance if this occurs.

• 51 Chlorphenamine (Entry 1 of 4) In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)when NOT separately specified in this table - either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• and ( if 'x' < 12)- Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 52 Chlorphenamine(Entry 2 of 4) In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)when NOT separately specified in this table  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. Do not give to children between 'x' and ‘y’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 53 Chlorphenamine(Entry 3 of 4) In oral preparations indicated for COUGH, COLD OR FLU:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 54 Chlorphenamine(Entry 4 of 4) In oral preparations indicated for COUGH, COLD OR FLU:

• which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 55 Choline salicylate In preparations for topical oral use  Do not exceed the recommended dose. Excessive or prolonged use can be harmful.

• 56 Cimetidine In Schedule 3 to the current Poisons Standard  Use only under medical supervision if you are taking other medicines. CAUTION: This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within 2 weeks, consult a doctor.

• 57 Cinchocaine(Entry 1 of 2) In preparations for rectal use only - If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

• 58 Cinchocaine(Entry 2 of 2) In preparations for dermal use  Do not apply to large areas of the body, except on the advice of a healthcare practitioner. If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

• 59 Cineole For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations or oils containing more than 25% of cineole (other than rosemary oil or camphor oil); and

• packed in containers having:- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or- a nominal capacity of 25 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 60 Cinnamon bark oil When included in a schedule to the current Poisons Standard  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSAvoid contact with skin. DO NOT SWALLOW. [g]

• 61 Cinnamon leaf oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 25% of cinnamon leaf oil; and

• packed in containers having:- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or- a nominal capacity of 25 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 62 Citric acid and other fruit acids(See also Alpha hydroxy acids) When used as active ingredients in preparations for topical use  This product may make your skin more sensitive to sunlight and other sources of UV light. Sun exposure should be limited by using a sunscreen and by wearing protective clothing. Transient stinging or irritation may occur when using this product. If irritation persists, discontinue use. If you have sensitive skin, test this product on a small area of skin before applying it to a large area. Not recommended for use on children and infants.

• 63 Clobetasone In preparations for dermal use  Do not use in the eyes. Do not use for acne. Do not use under waterproof bandages unless a doctor has told you to. Do not use for more than 7 days unless a doctor has told you to. CAUTION - Do not use for children under 12 years old unless a doctor has told you to.

• 64 Clotrimazole In preparations for vaginal use  Seek medical advice before first course of treatment. See a doctor if you are pregnant or diabetic. See a doctor if no better after [Insert number of days as per approved Product Information] days. See a doctor if problem returns.

• 65 Clove oil(Entry 1 of 2) For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 25% of clove oil; and

• packed in containers having:- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or- a nominal capacity of 25 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 66 Clove oil(Entry 2 of 2) When included in a schedule to the current Poisons Standard  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSAvoid contact with eyes. DO NOT SWALLOW. [g]

• 67 Coal tar In preparations for topical use  Avoid contact with eyes. If skin irritation occurs, discontinue use. Do not use for prolonged periods except on the advice of a doctor or pharmacist.

• 68 Datura spp In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness  If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

• 69 Desloratadine In medicines for oral use  If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.

• 70 Dexchlorpheniramine(Entry 1 of 4) In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)when NOT separately specified in this table - either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• and ( if 'x' < 12)- Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 71 Dexchlorpheniramine(Entry 2 of 4) In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)when NOT separately specified in this table  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. Do not give to children between 'x' and ‘y’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 72 Dexchlorpheniramine(Entry 3 of 4) In oral preparations indicated for COUGH, COLD OR FLU:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 73 Dexchlorpheniramine(Entry 4 of 4) In oral preparations indicated for COUGH, COLD OR FLU:

• which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 74 Dextromethorphan(Entry 1 of 2) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  Do not give to children under 12 years of age. If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 75 Dextromethorphan (Entry 2 of 2) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 76 Dibromopropamidine In medicines for ophthalmic use  Contact lens wearers should not use this product except on the advice of a doctor or optometrist. If your eye infection does not improve within 48 hours, seek immediate medical advice.

• 77 Diclofenac(Entry 1 of 3) In preparations for oral use only in adults and children aged 12 years and over  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to diclofenac or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with other products containing diclofenac, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.

• 78 Diclofenac (Entry 2 of 3) In preparations that include indications for oral use in children under 12 years of age  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to diclofenac or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with other products containing diclofenac, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy. Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

• 79 Diclofenac(Entry 3 of 3) When the preparation is for dermal use  Do not use [this product/insert name of product] if you are allergic to diclofenac or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor or pharmacist has told you to, do not use [this product/insert name of product] with other medicines that you are taking regularly.

• 80 Diethyltoluamide (DEET) All, including where present as an excipient  WARNING - May be dangerous, particularly to children, if you use large amounts on the skin, clothes or bedding or on large areas of the body, especially if you keep using it for a long time.

• 81 Dihydrocodeine(Entry 1 of 2) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  Do not give to children under 12 years of age. If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 82 Dihydrocodeine(Entry 2 of 2) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 83 Diphenhydramine (Entry 1 of 5) In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)when NOT separately specified in this table - either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• and ( if 'x' < 12)- Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 84 Diphenhydramine (Entry 2 of 5) In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)when NOT separately specified in this table  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. Do not give to children between 'x' and ‘y’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 85 Diphenhydramine (Entry 3 of 5) In oral preparations indicated for COUGH, COLD OR FLU:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 86 Diphenhydramine (Entry 4 of 5) In oral preparations indicated for COUGH, COLD OR FLU:

• which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 87 Diphenhydramine (Entry 5 of 5) In oral medicines indicated for SHORT TERM USE IN INSOMNIA:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 2) (Note: Diphenhydramine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Diphenhydramine (Entry 2 of 5))  This product should be taken on medical or pharmacist advice. Do not give to children under ‘x’ years of age. If breastfeeding, consult a doctor or pharmacist before use. Do not take this medicine for more than a few days. This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.

• 88 Diphenoxylate In medicines for oral use  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. Do not give to children under 12 years of age. If the condition persists after 2 days of treatment, seek medical advice as soon as possible. Do not use during pregnancy or breastfeeding unless advised by your doctor or pharmacist.

• 89 Doxylamine(Entry 1 of 5) In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)when NOT separately specified in this table - either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• and ( if 'x' < 12)- Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 90 Doxylamine(Entry 2 of 5) In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)when NOT separately specified in this table  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. Do not give to children between 'x' and ‘y’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 91 Doxylamine(Entry 3 of 5) In oral preparations indicated for COUGH, COLD OR FLU:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 92 Doxylamine(Entry 4 of 5) In oral preparations indicated for COUGH, COLD OR FLU:

• which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 93 Doxylamine(Entry 5 of 5) In oral medicines indicated for SHORT TERM USE IN INSOMNIA:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 2) (Note: Doxylamine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Doxylamine (Entry 2 of 5))  This product should be taken on medical or pharmacist advice. Do not give to children under ‘x’ years of age. If breastfeeding, consult a doctor or pharmacist before use. Do not take this medicine for more than a few days. This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.

• 94 Econazole In preparations for vaginal use  Seek medical advice before first course of treatment. See a doctor if you are pregnant or diabetic. See a doctor if no better after [Insert number of days as per approved Product Information] days. See a doctor if problem returns.

• 95 Eletriptan In divided oral preparations for relief of migraine  Do not use:- without a previous diagnosis of migraine by a doctor- if you have heart disease, peripheral vascular disease (a blood vessel disorder) or high blood pressure or have previously had a heart attack or stroke. Consult your doctor or pharmacist before use:- if you think you may be at risk of heart disease (including if you are post-menopausal or a male over the age of 40)- if you have liver or kidney problems or any other medical conditions- if you are taking any other medicines, including for migraine, depression or anxiety- if you are pregnant or breastfeeding. Speak to a doctor or pharmacist if your migraine attacks become more frequent. Overuse of this medicine may worsen your condition. This medicine may cause drowsiness. If affected, do not drive a vehicle or operate machinery.

• 96 Esomeprazole In medicines for oral use  CAUTION – This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within 2 weeks of completing the course, consult a doctor. Ask your doctor or pharmacist before use if you are taking other medicines regularly.

• 97 Eucalyptus oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 25% of eucalyptus oil; and

• packed in containers having:- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or- a nominal capacity of 25 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 98 Eugenol(Entry 1 of 2) For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 25% of eugenol; and

• packed in containers having:- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or- a nominal capacity of 25 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 99 Eugenol(Entry 2 of 2) When included in a schedule to the current Poisons Standard  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSAvoid contact with eyes. DO NOT SWALLOW. [g]

• 100 Famciclovir In medicines for oral use  If you are taking other medicines regularly, consult your pharmacist or doctor before use. If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine. Do not take [this product/insert name of product] if you are allergic to famciclovir or penciclovir. Do not take [this product/insert name of product] if you have problems with your immune system. Do not take [this product/insert name of product] if you have kidney problems, unless advised by a doctor. If you have high blood pressure, heart problems, liver problems, diabetes or other medical conditions, consult your pharmacist or doctor before use. If you have symptoms and signs of an infection other than your cold sore, consult your pharmacist or doctor before use.

• 101 Famotidine In medicines for oral use  CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within 2 weeks, consult a doctor.

• 102 Fennel oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations or oils containing more than 5% of methyl chavicol; and

• packed in containers having a nominal capacity of 25 mL or less, fitted with a restricted flow insert  KEEP OUT OF REACH OF CHILDREN.

• 103 Fexofenadine In medicines for oral use  If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.

• 104 Fluconazole In oral medicines for treatment of vaginal candidiasis  Seek medical advice before first course of treatment. Do not use if pregnant or [trying/likely] to become pregnant. See a doctor before use if you are diabetic. Ask your doctor or pharmacist before use if you are taking warfarin. See a doctor if no better after [Insert number of days as per approved Product Information] days. See a doctor if problem returns.

• 105 Fluorides(Entry 1 of 3) For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in dental hygiene products (other than pastes, powders or gels for the cleaning of teeth) containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride fitted with a child-resistant closure  Do not swallow. Do not use [this product/insert name of product] in children 6 years of age or less.

• 106 Fluorides(Entry 2 of 3) When included in a schedule to the current Poisons Standard except oral fluoride supplements  Do not swallow. Do not use [this product/insert name of product] in children 6 years of age or less.

• 107 Fluorides(Entry 3 of 3) In Schedule 2 to the current Poisons Standard in oral preparations as fluoride supplements  Do not use if pregnant. Use of this product is not necessary in areas supplied with fluoridated water. Do not use except on the advice of a dentist.

• 108 Flurbiprofen(Entry 1 of 2) In oral preparations that do NOT include indications for use in children under 12 years of age  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to flurbiprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with other products containing flurbiprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.

• 109 Flurbiprofen(Entry 2 of 2) In oral preparations that include indications for use in children under 12 years of age  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to flurbiprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with other products containing flurbiprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy. Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

• 110 Folic acid In preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects  Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice.

• 111 Glycollic acid (See Alpha hydroxy acids) When used as active ingredients in preparations for topical use  This product may make your skin more sensitive to sunlight and other sources of UV light. Sun exposure should be limited by using a sunscreen and by wearing protective clothing. Transient stinging or irritation may occur when using this product. If irritation persists, discontinue use. If you have sensitive skin, test this product on a small area of skin before applying it to a large area. Not recommended for use on children and infants.

• 112 Guaifenesin(Guaiphenesin)(Entry 1 of 2) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  Do not give to children under 12 years of age. If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 113 Guaifenesin (Guaiphenesin)(Entry 2 of 2) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 114 Hexachlorophane In preparations for skin cleansing purposes containing 3% or less of hexachlorophane.  For external washing only. Rinse skin thoroughly after use.

• 115 Hydrocortisone(Entry 1 of 2) In preparations for dermal use  either- Do not use for children under 2 years old unless a doctor has told you to.or (if Schedule 2 or 3 to the current Poisons Standard excludes use in children under 12 years of age)- Do not use for children under 12 years of age. Do not use in the eyes. Do not use for acne. Do not use under waterproof bandages unless a doctor has told you to. Do not use for more than 7 days unless a doctor has told you to.

• 116 Hydrocortisone(Entry 2 of 2) In preparations for topical rectal use  Do not use for children under 2 years old unless a doctor has told you to. Do not use for more than 7 days unless a doctor has told you to.

• 117 Hydrogen peroxide(Entry 1 of 3) In concentrations of more than 3% up to 10%  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSIrritantAvoid contact with eyes. DO NOT SWALLOW. [g]

• 118 Hydrogen peroxide(Entry 2 of 3) In concentrations of more than 10% up to 20%  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSIrritantAttacks eyes - protect eyes when using.

• 119 Hydrogen peroxide(Entry 3 of 3) In concentrations of more than 20%  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSCorrosiveAttacks eyes - protect eyes when usingAvoid contact with skin.

• 120 Hydroquinone In Schedule 2 to the current Poisons Standard  WARNING - If a pigmented spot or mole has recently become darker, changed colour, become enlarged or itchy, or bleeds, do not use this product, see your doctor immediately. Do not use on children. Do not use near the eyes. Mild irritation may occur; stop use if it becomes severe. If fading is not evident in 3 months, seek doctor’s advice. Do not exceed recommended dose. Excessive or prolonged use should be avoided because darkening of the skin can occur.

• 121 Hydroxyanthracene derivatives such as those from:

• Senna(Entry 1 of 3) Where the MRDD contains MORE than 10 mg and the product IS promoted or marketed as a laxative  Not recommended for use by children under 12 years of age. If symptoms persist, seek advice from a health care practitioner. Drink plenty of water. Prolonged use may cause serious bowel problems. Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product.

• 122 Hydroxyanthracene derivatives such as those from:

• Senna(Entry 2 of 3) Where the MRDD contains MORE than 10 mg and the product IS NOT promoted or marketed as a laxative  Not recommended for use by children under 12 years of age. If symptoms persist, seek advice from a health care practitioner. This product may have a laxative effect. Prolonged use may cause serious bowel problems. Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product. This product contains [insert name of the herb(s) or the chemical component(s)].

• 123 Hydroxyanthracene derivatives such as those from:

• Senna(Entry 3 of 3) Where the MRDD contains 10 mg OR LESS and the product IS promoted or marketed as laxative  Not recommended for use by children under 12 years of age. If symptoms persist, seek advice from a health care practitioner. Drink plenty of water. Prolonged use may cause serious bowel problems.

• 124 8-Hydroxyquinoline (including salts and derivatives) In preparations for internal use  Do not take for periods longer than 4 weeks except on medical advice.

• 125 Hyoscine In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness  If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

• 126 Hyoscyamine In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness  If the condition persists after 2 days of treatment, seek medical advice as soon as possible. Do not use during pregnancy or breastfeeding unless advised by your doctor or pharmacist.

• 127 Hyoscyamus niger In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness  If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

• 128 Ibuprofen(Entry 1 of 6) For the purpose of exclusion from the schedules to the current Poisons Standard, when the preparation is for oral use in adults and children aged 12 years and over.  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy. Unless a doctor has told you to, do not use if you are aged 65 years or over.

• 129 Ibuprofen (Entry 2 of 6) When included in a schedule to the current Poisons Standard for oral use in adults and children aged 12 years and over  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.

• 130 Ibuprofen(Entry 3 of 6) For the purpose of exclusion from the schedules to the current Poisons Standard, for oral use in children under 12 years of age  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy. Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting. Unless a doctor has told you to, do not use if you are aged 65 years or over. Do not use in children 6 years of age or less.

• 131 Ibuprofen(Entry 4 of 6) When included in a schedule to the current Poisons Standard for oral use in children under 12 years of age  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy. Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

• 132 Ibuprofen(Entry 5 of 6) In combination with paracetamol, in medicines for oral use  Do not give to children under 12 years of age. Adults: Keep to the recommended dose. Do not take this medicine for longer than a few days at a time unless advised to by a doctor. Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if pregnant or trying to become pregnant. Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless a doctor has told you to, do not use if you are aged 65 years or over. Do not take with other products containing paracetamol, ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly, unless advised to do so by a doctor or pharmacist. If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) or go to hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

• 133 Ibuprofen(Entry 6 of 6) In preparations for dermal use  Do not use [this product/insert name of product] if you are allergic to ibuprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor or pharmacist has told you to, do not use [this product/insert name of product] with other medicines that you are taking regularly.

• 134 Indomethacin In preparations for external use  Do not use [this product/insert name of product] if you are allergic to indomethacin or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly.

• 135 Iodine (Entry 1 of 2) In preparations for dermal use  If skin irritation or rash occurs, discontinue use immediately.

• 136 Iodine (Entry 2 of 2) In preparations for internal use containing 300 micrograms or more of iodine per recommended daily dose  CAUTION - Total iodine intake may exceed recommended level when taking this preparation. WARNING - Contains iodine - do not take when pregnant except on physician’s advice.

• 137 Ipecacuanha(Entry 1 of 2) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  Do not give to children under 12 years of age. If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 138 Ipecacuanha(Entry 2 of 2) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.- If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 139 Ipratropium bromide In metered aerosols  This preparation should be part of an overall treatment plan regularly assessed with your doctor.

• 140 Ketoprofen(Entry 1 of 3) In preparations for oral use in adults and children aged 12 years and over  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to ketoprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with products containing ketoprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.

• 141 Ketoprofen(Entry 2 of 3) In preparations for oral use in children under 12 years of age  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to ketoprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with products containing ketoprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy. Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

• 142 Ketoprofen(Entry 3 of 3) In preparations for dermal use  Do not use [this product/insert name of product] if you are allergic to ketoprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly.

• 143 Lactic acid(See Alpha hydroxy acids) When used as active ingredients in preparations for topical use  This product may make your skin more sensitive to sunlight and other sources of UV light. Sun exposure should be limited by using a sunscreen and by wearing protective clothing. Transient stinging or irritation may occur when using this product. If irritation persists, discontinue use. If you have sensitive skin, test this product on a small area of skin before applying it to a large area. Not recommended for use on children and infants.

• 144 Lansoprazole In medicines for oral use  CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within 2 weeks of completing the course, consult a doctor. Ask your doctor or pharmacist before use if you are taking other medicines regularly.

• 145 Lemon oil For the purpose of exclusion from the schedules to the current Poisons Standard  Application to skin may increase sensitivity to sunlight.

• 146 Leptospermum scoparium oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 25% of Leptospermum scoparium oil; and

• packed in containers having:- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or- a nominal capacity of 25 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 147 Levocabastine(Entry 1 of 2) In eye or nasal preparations containing 0.5 mg/mL or less of levocabastine  Do not use if pregnant.

• 148 Levocabastine(Entry 2 of 2) In eye or nasal preparations containing MORE THAN 0.5 mg per mL of levocabastine.  Do not use if pregnant. either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• 149 Levocetirizine(Entry 1 of 2) In preparations for oral use labelled for use in adults  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.

• 150 Levocetirizine(Entry 2 of 2) In preparations for oral use specifically labelled for use only in children (between 1 year and 12 years of age)  This medication may cause drowsiness.

• 151 Lidocaine (Lignocaine)(Entry 1 of 4) In dermal preparations containing MORE THAN 2% of total local anaesthetic substances  Do not apply to large areas of the body, except on the advice of a healthcare practitioner. If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

• 152 Lidocaine (Lignocaine)(Entry 2 of 4) In dermal preparations containing 2% OR LESS of total local anaesthetic substances  If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

• 153 Lidocaine (Lignocaine)(Entry 3 of 4) In preparations for topical oral use containing more than 1.5% lidocaine.  Do not use for teething pain in children.

• 154 Lidocaine (Lignocaine)(Entry 4 of 4) In lozenges  Do not take hot food or drink if the mouth feels numb after taking this product as it may burn the mouth. Do not give to children under 6 years of age, unless recommended by a doctor, pharmacist or dentist.

• 155 Lime oil For the purpose of exclusion from the schedules to the current Poisons Standard  Application to skin may increase sensitivity to sunlight.

• 156 Lindane In preparations for external use  Do not use on broken skin. Ask your doctor or pharmacist before use. This preparation should be used with caution on infants, small children and pregnant or breastfeeding women.

• 157 Loperamide hydrochloride In medicines for oral use  If the condition persists after 2 days of treatment, seek medical advice as soon as possible. If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine. Do not give to children under 12 years of age. Drink plenty of fluids as fluid and electrolyte depletion may occur with diarrhoea. If dehydration is suspected seek medical attention. Do not take if you have a medical condition where constipation should be avoided. See your doctor or pharmacist before taking [this product/insert name of product] if you have a fever, severe stomach pain, bloody diarrhoea or ongoing condition affecting the bowel.

• 158 Loratadine In medicines for oral use  If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.

• 159 Marjoram oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 50% of marjoram oil; and

• packed in containers having a nominal capacity of 50 mL or less, fitted with a restricted flow insert  KEEP OUT OF REACH OF CHILDREN.

• 160 Mefenamic acid When indicated exclusively for the treatment of dysmenorrhoea  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to mefenamic acid or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with other products containing mefenamic acid, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.

• 161 Melaleuca oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 25% of melaleuca oil; and

• when packed in containers having:- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or- a nominal capacity of 25 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 162 Melatonin In modified-release tablets containing 2 mg or less of melatonin  Do not use if:- you are under 55 years of age- you are taking any other medicines for sleep- you have liver problems- you are pregnant or breastfeeding. Unless a doctor has told you to, do not use:- for more than 3 weeks- if you have kidney problems- if you have an autoimmune disease. Consult a pharmacist or doctor before use if you are taking other medicines regularly. Do not drink alcohol while taking this medicine. This medication may cause drowsiness. If affected do not drive or operate machinery.

• 163 Menthol(Entry 1 of 5) In dermal preparations containing 1% or less, EXCEPT patches  Avoid contact with eyes.

• 164 Menthol(Entry 2 of 5) In dermal preparations containing more than 1% and up to 5%, EXCEPT patches  Avoid contact with eyes. If you have sensitive skin, test this product on a small area of skin before applying it to a large area. If irritation develops, discontinue use.

• 165 Menthol(Entry 3 of 5) In dermal preparations containing more than 5%, EXCEPT patches  Avoid contact with eyes. Contains a high concentration of menthol, which can cause severe skin irritation. If you have sensitive skin, test this product on a small area of skin before applying it to a large area. If irritation develops, discontinue use.

• 166 Menthol(Entry 4 of 5) In dermal patches containing more than 1% and up to 5%  If irritation develops, discontinue use.

• 167 Menthol(Entry 5 of 5) In dermal patches containing more than 5%  Contains a high concentration of menthol, which can cause severe skin irritation. If irritation develops, discontinue use.

• 168 Methyl salicylate(Entry 1 of 2) In dermal preparations containing 1% or less of methyl salicylate  Do not use if pregnant or likely to become pregnant. Do not use in children 6 years of age or less. Application to skin may increase sensitivity to sunlight. Avoid prolonged exposure in the sun.

• 169 Methyl salicylate(Entry 2 of 2) In dermal preparations containing more than 1% of methyl salicylate  Do not use if pregnant or likely to become pregnant. Do not use in children 6 years of age or less. Application to skin may increase sensitivity to sunlight. Avoid prolonged exposure in the sun. If irritation develops, discontinue use.

• 170 Metoclopramide In medicines for oral use  Do not use in children and adolescents aged under 18 years. Tell your doctor or pharmacist before use if you are taking other medicines. Do not use if you have epilepsy [(seizures)/(fits)].

• 171 Methoxamine In nasal decongestant preparations for topical use  If congestion persists consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen.

• 172 Miconazole(Entry 1 of 2) In preparations for vaginal use  Seek medical advice before first course of treatment. See a doctor before use if you are pregnant or diabetic. Ask your doctor or pharmacist before use if you are taking warfarin. See a doctor if no better after [Insert number of days as per approved Product Information] days. See a doctor if problem returns.

• 173 Miconazole(Entry 2 of 2) In preparations for topical oral use  Ask your doctor or pharmacist before use if you are taking warfarin.

• 174 Mometasone(Entry 1 of 2) In preparations for dermal use  Do not use:- in or around the eyes- for acne- on broken skin or skin infections (e.g. cold sores, shingles, thrush, tinea)- if you are sensitive to any corticosteroids. Unless a doctor has told you to, do not use:- on the face, large areas of the skin, or areas that rub together- under a bandage, dressing, nappies or plastic pants- for more than 7 days- if you are pregnant or breastfeeding- for children under 12 years old. If irritation occurs, discontinue use and seek medical advice. Seek medical advice if there is no improvement in symptoms after using for 1 week.

• 175 Mometasone(Entry 2 of 2) In nasal spray preparations  Do not exceed the maximum stated dose. Do not use for more than 6 months without the advice of your doctor or pharmacist. See your doctor or pharmacist before using this product if:- you have a nasal or sinus infection- you have recently had an injury or surgery to your nose- you have ulceration in your nose- you are pregnant or breastfeeding. See your doctor or pharmacist if:- symptoms are not relieved within 7 days- your nose bleeds- you develop signs or symptoms of a nasal or sinus infection such as fever, pain or swelling, or discoloured nasal discharge- you have eye pain or visual disturbances.

• 176 Naphazoline(Entry 1 of 2) In nasal decongestant preparations for topical use  If congestion persists consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen.

• 177 Naphazoline(Entry 2 of 2) In topical eye preparations  Prolonged use may be harmful. Consult a doctor or pharmacist if using other eye products. Do not use if you have glaucoma or other serious eye conditions. If symptoms persist, consult a doctor or pharmacist.

• 178 Naproxen(Entry 1 of 2) In preparations for oral use in adults and children aged 12 years and over  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to naproxen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with other products containing naproxen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.

• 179 Naproxen(Entry 2 of 2) When the preparation includes indications for oral use in children under 12 years of age  Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to naproxen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless advised by your doctor or pharmacist, do not use with other products containing naproxen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly. Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.  Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

• 180 Nasal decongestant preparations, including:

• Methoxamine

• Naphazoline

• Oxymetazoline

• Phenylephrine

• Tetrahydrozoline

• Tramazoline

• Tymazoline

• Xylometazoline When in nasal decongestant preparations for topical use  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen.

• 181 Nizatidine In medicines for oral use  CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within 2 weeks, consult a doctor.

• 182 Nutmeg oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 50% of nutmeg oil; and

• packed in containers having a nominal capacity of 25 mL or less, fitted with a restricted flow insert  KEEP OUT OF REACH OF CHILDREN.

• 183 Nystatin In preparations for vaginal use  See a doctor if you are pregnant or diabetic. Seek medical advice before first course of treatment. If getting better, keep using for [insert number of days as per approved Product Information] days. See a doctor if no better after [Insert number of days as per approved Product Information] days. See a doctor if problem returns.

• 184 Omeprazole In preparations for oral use  CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within 2 weeks of completing the course, consult a doctor. Ask your doctor or pharmacist before use if you are taking other medicines regularly.

• 185 Orange oil (bitter) For the purpose of exclusion from the schedules to the current Poisons Standard  Application to skin may increase sensitivity to sunlight.

• 186 Oxymetazoline(Entry 1 of 4) In nasal decongestant preparations for topical use  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen.

• 187 Oxymetazoline(Entry 2 of 4)(See also vasoconstrictor eye drops) In topical eye preparations  Prolonged use may be harmful. Consult a doctor or pharmacist if using other eye products. Do not use if you have glaucoma or other serious eye conditions. If symptoms persist, consult a doctor or pharmacist.

• 188 Oxymetazoline(Entry 3 of 4) In nasal decongestant preparations for topical use indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen. Do not give to children under 12 years of age.

• 189 Oxymetazoline(Entry 4 of 4) In nasal decongestant preparations for topical use indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen. Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 190 Pantoprazole In medicines for oral use  CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within 2 weeks of completing the course, consult a doctor. Ask your doctor or pharmacist before use if you are taking other medicines regularly.

• 191 Paracetamol(Entry 1 of 3) For the purpose of exclusion from the schedules to the current Poisons Standard  Adults: Keep to the recommended dose. Do not take this medicine for longer than a few days at a time unless advised to by a doctor. Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor. If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) or go to hospital straight away even if you feel well because of the risk of delayed, serious liver damage. Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.

• 192 Paracetamol(Entry 2 of 3) In Schedule 2 or 3 to the current Poisons Standard  either or both- Adults: Keep to the recommended dose. Do not take this medicine for longer than a few days at a time unless advised to by a doctor.- Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor. If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) or go to hospital straight away even if you feel well because of the risk of delayed, serious liver damage. Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.

• 193 Paracetamol(Entry 3 of 3) In combination with ibuprofen, in medicines for oral use  Do not give to children under 12 years of age. Adults: Keep to the recommended dose. Do not take this medicine for longer than a few days at a time unless advised to by a doctor. Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Do not use if pregnant or trying to become pregnant. Do not use if you have a stomach ulcer. Do not use if you have impaired kidney function. Do not use if you have heart failure. Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines. If you get an allergic reaction, stop taking and see your doctor immediately. Unless a doctor has told you to, do not use if you have asthma. Unless a doctor has told you to, do not use if you are aged 65 years or over. Do not take with other products containing paracetamol, ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly, unless advised to do so by a doctor or pharmacist. If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) or go to hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

• 194 Pennyroyal oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 4% of d-pulegone; and

• when packed in containers having a nominal capacity of 15 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 195 Pentoxyverine(Entry 1 of 2) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  Do not give to children under 12 years of age. If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 196 Pentoxyverine(Entry 2 of 2) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 197 Permanganates(see also Potassium permanganate) When included in Schedule 6 to the current Poisons Standard  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSCorrosiveAvoid contact of the crystals or strong solutions with the eyes, mouth, nose and other mucous membranes.

• 198 Pheniramine(Entry 1 of 4) In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)when NOT separately specified in this table - either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• and ( if 'x' < 12)- Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 199 Pheniramine(Entry 2 of 4) In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)when NOT separately specified in this table  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. Do not give to children between 'x' and ‘y’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 200 Pheniramine(Entry 3 of 4) In oral preparations indicated for COUGH, COLD OR FLU:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.  Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 201 Pheniramine(Entry 4 of 4) In oral preparations indicated for COUGH, COLD OR FLU:

• which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 202 Phenol and any other homologue of phenol When included in Schedule 2 to the current Poisons Standard  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSAvoid contact with eyesAvoid contact with skin. DO NOT SWALLOW. [g]

• 203 Phenylephrine(Entry 1 of 7) In nasal decongestant preparations for topical use  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen.

• 204 Phenylephrine(Entry 2 of 7)(See also vasoconstrictor eye drops) In topical eye preparations  Prolonged use may be harmful. Consult a doctor or pharmacist if using other eye products. Do not use if you have glaucoma or other serious eye conditions. If symptoms persist, consult a doctor or pharmacist.

• 205 Phenylephrine(Entry 3 of 7) In oral preparations that are NOT indicated for cough, cold or flu  See your doctor or pharmacist before taking [this product/insert name of product] if you have high blood pressure or heart problems or are taking antidepressant medication. This product may cause sleeplessness.

• 206 Phenylephrine(Entry 4 of 7) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  See your doctor or pharmacist before taking [this product/insert name of product] if you have high blood pressure or heart problems or are taking antidepressant medication. This product may cause sleeplessness. Do not give to children under 12 years of age.

• 207 Phenylephrine(Entry 5 of 7) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  See your doctor or pharmacist before taking [this product/insert name of product] if you have high blood pressure or heart problems or are taking antidepressant medication. This product may cause sleeplessness.  Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 208 PhenylephrineEntry 6 of 7) In nasal decongestant preparations for topical use indicated for cough, cold or flu, which DO NOT include dosage instructions for children aged under 12 years - If congestion persists, consult your doctor or pharmacist.

• Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

• Frequent or prolonged use may cause nasal congestion to recur or worsen. Do not give to children under 12 years of age.

• 209 Phenylephrine(Entry 7 of 7) In nasal decongestant preparations for topical use indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11) - If congestion persists, consult your doctor or pharmacist.

• Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

• Frequent or prolonged use may cause nasal congestion to recur or worsen.

• either (if ‘x’ is 11)- Do not give to children under ‘x’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner. or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 210 Pholcodine(Entry 1 of 2) In oral preparations indicated for cough, cold or flu, and the preparation does not include dosage instructions for children aged under 12 years  Do not give to children under 12 years of age. If [coughing/symptoms] persist(s) consult your doctor or pharmacist.

• 211 Pholcodine(Entry 2 of 2) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. If [coughing/symptoms] persist(s) consult your doctor or pharmacist.

• 212 Piper methysticum For the purpose of exclusion from the schedules to the current Poisons Standard in medicines for oral use  Not recommended for use by pregnant or lactating women. WARNING: Not for prolonged use. If symptoms persist, seek advice from a health care practitioner. May harm the liver.

• 213 Podophyllin(Entry 1 of 2) In liquid preparations OTHER THAN preparations specifically for use on the anal or genital areas  WARNING - Do not use on face or on anal or genital areas except on doctor’s advice.

• 214 Podophyllin(Entry 1 of 2) In solid or semi-solid preparations OTHER THAN preparations specifically for use on the anal or genital areas  WARNING - Do not use on face or on anal or genital areas.

• 215 Podophyllotoxin(Entry 1 of 2) In liquid preparations OTHER THAN preparations specifically for use on the anal or genital areas.  WARNING - Do not use on face or on anal or genital areas except on doctor’s advice.

• 216 Podophyllotoxin(Entry 2 of 2) In solid or semi-solid preparations OTHER THAN preparations specifically for use on the anal or genital areas.  WARNING - Do not use on face or on anal or genital areas.

• 217 Potassium permanganate In Schedule 6 to the current Poisons Standard  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSCorrosiveAvoid contact of the crystals or strong solutions with the eyes, mouth, nose and other mucous membranes.

• 218 Povidone-iodine In preparations for dermal use  If skin irritation or rash occurs, discontinue use immediately.

• 219 Promethazine(Entry 1 of 5) In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)when NOT separately specified in this table - either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• and ( if 'x' < 12)- Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 220 Promethazine(Entry 2 of 5) In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)when NOT separately specified in this table  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. Do not give to children between 'x' and ‘y’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner. If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

• 221 Promethazine(Entry 3 of 5) In oral preparations indicated for COUGH, COLD OR FLU:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 222 Promethazine(Entry 4 of 5) In oral preparations indicated for COUGH, COLD OR FLU:

• which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 223 Promethazine(Entry 5 of 5) In oral medicines indicated for SHORT TERM USE IN INSOMNIA:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 2) (Note: Promethazine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Promethazine (Entry 2 of 5))  This product should be taken on medical or pharmacist advice. Do not give to children under ‘x’ years of age. If pregnant or likely to become pregnant, or if breastfeeding, consult a doctor or pharmacist before use. Do not take this medicine for more than a few days. This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.

• 224 Propamidine In medicines for ophthalmic use  Contact lens wearers should not use this product except on the advice of a doctor or optometrist. If your eye infection does not improve within 48 hours, seek immediate medical advice.

• 225 Proton pump inhibitors including:

• Esomeprazole

• Lansoprazole

• Omeprazole

• Pantoprazole

• Rabeprazole In medicines for oral use  CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within 2 weeks of completing the course, consult a doctor. Ask your doctor or pharmacist before use if you are taking other medicines regularly.

• 226 Pseudoephedrine(Entry 1 of 3) When the preparation is NOT indicated for use for cough, cold or flu  See your doctor or pharmacist before taking [this product/insert name of product] if you have high blood pressure or heart problems or are taking antidepressant medication. [This product/insert name of product] may cause sleeplessness if it is taken up to several hours before going to bed.

• 227 Pseudoephedrine(Entry 2 of 3) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  See your doctor or pharmacist before taking [this product/insert name of product] if you have high blood pressure or heart problems or are taking antidepressant medication. [This product/insert name of product] may cause sleeplessness if it is taken up to several hours before going to bed. Do not give to children under 12 years of age.

• 228 Pseudoephedrine(Entry 3 of 3) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  See your doctor or pharmacist before taking [this product/insert name of product] if you have high blood pressure or heart problems or are taking antidepressant medication. [This product/insert name of product] may cause sleeplessness if it is taken up to several hours before going to bed. Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 229 Psyllium In medicines for oral ingestion which include dosage instructions for children  Should only be used for children on medical advice.

• 230 Pyridoxal(see also Vitamin B6, Vitamins)(Entry 1 of 2) In SINGLE-INGREDIENT preparations containing 200 mg or less but more than 50 mg per recommended daily dose  WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible.

• 231 Pyridoxal(see also Vitamin B6, Vitamins)(Entry 2 of 2) In MULTI-INGREDIENT preparations containing 200 mg or less but more than 50 mg per recommended daily dose  WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. Contains vitamin B6.

• 232 Pyridoxine(see also Vitamin B6, Vitamins)(Entry 1 of 2) In SINGLE- INGREDIENT preparations containing 200 mg or less but more than 50 mg per recommended daily dose  WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible.

• 233 Pyridoxine(see also Vitamin B6, Vitamins)(Entry 2 of 2) In MULTI-INGREDIENT preparations containing 200 mg or less but more than 50 mg per recommended daily dose  WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. Contains vitamin B6.

• 234 Pyrithione zinc In preparations for external use for treatment of the scalp either Keep out of eyes.or If in eyes, rinse well with water.

• 235 Rabeprazole In medicines for oral use  CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within 2 weeks of completing the course, consult a doctor. Ask your doctor or pharmacist before use if you are taking other medicines regularly.

• 236 Ranitidine Medicines for oral use  CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within 2 weeks, consult a doctor.

• 237 Rizatriptan In divided oral preparations for relief of migraine  Do not use:- without a previous diagnosis of migraine by a doctor- if you have heart disease, peripheral vascular disease (a blood vessel disorder) or high blood pressure or have previously had a heart attack or stroke. Consult your doctor or pharmacist before use:- if you think you may be at risk of heart disease (including if you are post-menopausal or a male over the age of 40)- if you have liver or kidney problems or any other medical conditions- if you are taking other medicines for migraine- if you are taking, or have taken in the last 2 weeks, medicine for depression or anxiety- if you are pregnant or breastfeeding. Speak to a doctor or pharmacist if your migraine attacks become more frequent. Overuse of this medicine may worsen your condition. This medicine may cause drowsiness. If affected, do not drive a vehicle or operate machinery.

• 238 Safrole When included in a schedule to the current Poisons Standard  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSAvoid contact with eyes.

• 239 Sage oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 4% of thujone; and

• packed in containers having a nominal capacity of 15 mL or less, fitted with a restricted flow insert and child-resistant closure  KEEP OUT OF REACH OF CHILDREN. NOT TO BE TAKEN.

• 240 Salbutamol In metered aerosols or in dry powder formulations  This preparation should be part of an overall treatment plan regularly assessed with your doctor.

• 241 Sassafras oil When included in a schedule to the current Poisons Standard  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSAvoid contact with eyes.

• 242 Senega(Entry 1 of 2) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  Do not give to children under 12 years of age. If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

• 243 Senega(Entry 2 of 2) In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 244 Silver(see also Silver salts) For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in chewing gum containing 5 mg or less of silver per dosage unit; or

• in solutions for oral use containing 0 3% or less of silver  Overuse may stain skin or mouth.

• 245 Silver salts(see also Silver) In smoking deterrents.  WARNING - Overuse may stain the skin or mouth.

• 246 Sodium fluoride(see also Fluorides) In preparations for ingestion when in Schedule 2 to the current Poisons Standard  Use of this product is not necessary in areas supplied with fluoridated water.

• 247 Star anise oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 50% of star anise oil; and

• packed in containers having a nominal capacity of 50 mL or less, fitted with a restricted flow insert  KEEP OUT OF REACH OF CHILDREN.

• 248 Sulfacetamide In medicines for ophthalmic use  Contact lens wearers should not use this product except on the advice of a doctor or optometrist. If your eye infection does not improve within 48 hours, seek immediate medical advice.

• 249 Sumatriptan In divided oral preparations for relief of migraine  Do not use:- without a previous diagnosis of migraine by a doctor- if you have heart disease, peripheral vascular disease (a blood vessel disorder) or high blood pressure or have previously had a heart attack or stroke. Consult your doctor or pharmacist before use:- if you think you may be at risk of heart disease (including if you are post-menopausal or a male over the age of 40)- if you have liver or kidney problems or any other medical conditions- if you are taking other medicines for migraine- if you are taking, or have taken in the last 2 weeks, medicine for depression or anxiety- if you are pregnant or breastfeeding. Speak to a doctor or pharmacist if your migraine attacks become more frequent. Overuse of this medicine may worsen your condition. This medicine may cause drowsiness. If affected, do not drive a vehicle or operate machinery.

• 250 Symphytum spp In Schedule 5 to the current Poisons Standard  either- READ SAFETY DIRECTIONS. [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f] SAFETY DIRECTIONSDo not use on broken skinDo not use under occlusive dressing. DO NOT SWALLOW. [g]

• 251 Terbutaline In metered aerosols  This preparation should be part of an overall treatment plan regularly assessed with your doctor.

• 252 Tetracaine (amethocaine)(Entry 1 of 2) When included in Schedule 2 to the current Poisons Standard and for dermal use  Do not apply to large areas of the body, except on the advice of a healthcare practitioner. If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

• 253 Tetracaine (amethocaine)(Entry 2 of 2) For the purpose of exclusion from the schedules to the current Poisons Standard when in dermal preparations containing 2% OR LESS of total local anaesthetic substances  If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

• 254 Tetrahydrozoline(Entry 1 of 2) In nasal decongestant preparations for topical use  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen.

• 255 Tetrahydrozoline (Entry 2 of 2)(See also vasoconstrictor eye drops) In topical eye preparations  Prolonged use may be harmful. Consult a doctor or pharmacist if using other eye products. Do not use if you have glaucoma or other serious eye conditions. If symptoms persist, consult a doctor or pharmacist.

• 256 Thyme oil For the purpose of exclusion from the schedules to the current Poisons Standard when:

• in preparations containing more than 50% of thyme oil; and

• packed in containers having a nominal capacity of 25 mL or less, fitted with a restricted flow insert  KEEP OUT OF REACH OF CHILDREN.

• 257 Tioconazole In preparations for vaginal use  Do not use if you are pregnant. See a doctor before use if you are diabetic. Seek medical advice before first course of treatment. See a doctor if no better after [Insert number of days as per approved Product Information] days. See a doctor if problem returns.

• 258 Tramazoline(Entry 1 of 2) In nasal decongestant preparations for topical use  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen.

• 259 Tramazoline(Entry 2 of 2)(See also vasoconstrictor eye drops) In topical eye preparations  Prolonged use may be harmful. Consult a doctor or pharmacist if using other eye products. Do not use if you have glaucoma or other serious eye conditions. If symptoms persist, consult a doctor or pharmacist.

• 260 Triamcinolone In topical preparations for the treatment of mouth ulcers either

• See a [doctor / doctor or dentist] if no better after [Insert number of days as per approved Product Information] days.or

• If symptoms persist beyond 5 days consult a [doctor / doctor or dentist].

• 261 Triprolidine(Entry 1 of 4) In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)when NOT separately specified in this table - either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

• and ( if 'x' < 12)- Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 262 Triprolidine(Entry 2 of 4) In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)when NOT separately specified in this table  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. Do not give to children between 'x' and ‘y’ years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 263 Triprolidine(Entry 3 of 4) In oral preparations indicated for COUGH, COLD OR FLU:

• which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)  either- This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.or- This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 264 Triprolidine(Entry 4 of 4) In oral preparations indicated for COUGH, COLD OR FLU:

• which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)  This medication may cause drowsiness. Do not give to children under ‘x’ years of age. and (if ‘x’ < 12)- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 265 Tymazoline(Entry 1 of 2) In nasal decongestant preparations for topical use  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen.

• 266 Tymazoline(Entry 2 of 2)(See also Vasoconstrictor eye drops) In topical eye preparations  Prolonged use may be harmful. Consult a doctor or pharmacist if using other eye products. Do not use if you have glaucoma or other serious eye conditions. If symptoms persist, consult a doctor or pharmacist.

• 267 Vasoconstrictor eye drops including:

• Naphazoline

• Oxymetazoline

• Phenylephrine

• Tetrahydrozoline

• Tramazoline

• Tymazoline

• Xylometazoline In topical eye preparations  Prolonged use may be harmful. Consult a doctor or pharmacist if using other eye products. Do not use if you have glaucoma or other serious eye conditions. If symptoms persist, consult a doctor or pharmacist.

• 268 Vegetable oil phytosterol esters In preparations for oral ingestion  Not suitable for use by pregnant or lactating women. There is no benefit from taking more than 3 g/ day of phytosterols from all sources.

• 269 Vitamin A(See also Vitamins) In medicines for oral use that are labelled to be used by females of childbearing age containing MORE THAN:

• 33 micrograms retinol equivalents of vitamin A per dosage unit of a divided preparation; or

• 33 micrograms retinol equivalents of vitamin A per gram of an undivided preparation  The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men. WARNING – When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects. [c] If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist. [c]

• 270 Vitamin B6

• pyridoxal

• pyridoxine(Entry 1 of 2)(See also Vitamins) In SINGLE-INGREDIENT preparations containing 200 mg or less but more than 50 mg of [pyridoxine / pyridoxal] per recommended daily dose  WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible.

• 271 Vitamin B6

• pyridoxal

• pyridoxine(Entry 2 of 2)(See also Vitamins) In MULTI-INGREDIENT preparations containing 200 mg or less but more than 50 mg of [pyridoxine / pyridoxal] per recommended daily dose  WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. Contains vitamin B6.

• 272 Xylometazoline(Entry 1 of 4) When in nasal decongestant preparations for topical use  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen.

• 273 Xylometazoline(Entry 2 of 4)(See also Vasoconstrictor eye drops) In topical eye preparations  Prolonged use may be harmful. Consult a doctor or pharmacist if using other eye products. Do not use if you have glaucoma or other serious eye conditions. If symptoms persist, consult a doctor or pharmacist.

• 274 Xylometazoline(Entry 3 of 4) In nasal decongestant preparations for topical use indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen. Do not give to children under 12 years of age.

• 275 Xylometazoline(Entry 4 of 4) In nasal decongestant preparations for topical use indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)  If congestion persists, consult your doctor or pharmacist. Do not use for more than 3 days at a time unless advised by a doctor or pharmacist. Frequent or prolonged use may cause nasal congestion to recur or worsen. Do not give to children under ‘x’ years of age. either (if ‘x’ is 11)- Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.or (if ‘x’ is 6, 7, 8, 9 or 10)- Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.

• 276 Zinc compounds In preparations for internal use with a recommended daily dose of more than 25 mg of zinc either

• WARNING - This medication may be dangerous when used in large amounts or for a long period.or

• WARNING – Contains zinc, which may be dangerous when used in large amounts or for a long period.

• 277 Zolmitriptan In divided oral preparations for relief of migraine  Do not use:- without a previous diagnosis of migraine by a doctor- if you have heart disease, peripheral vascular disease (a blood vessel disorder) or high blood pressure or have previously had a heart attack or stroke. Consult your doctor or pharmacist before use:- if you think you may be at risk of heart disease (including if you are post-menopausal or a male over the age of 40)- if you have liver or kidney problems or any other medical conditions- if you are taking other medicines for migraine- if you are taking, or have taken in the last 2 weeks, medicine for depression or anxiety- if you are pregnant or breastfeeding. Speak to a doctor or pharmacist if your migraine attacks become more frequent. Overuse of this medicine may worsen your condition. This medicine may cause drowsiness. If affected, do not drive a vehicle or operate machinery.