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Name of Specification
1 Name of Specification
This Specification is the Medicines Advisory Statements Specification 2016
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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This Specification under the Therapeutic Goods Act 1989 requires specific, mandatory advisory statements on labels of non‑prescription medicines sold in Australia, applying to sponsors and manufacturers and informing consumers of risks (e.g., age limits, pregnancy, drowsiness, liver risk).
It prescribes exact wording and formatting for hundreds of substances, with transitional (first 18 months) and updated schedules, ensuring consistent safety warnings derived from pharmacovigilance and clinical data.
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1 Name of Specification
This Specification is the Medicines Advisory Statements Specification 2016
2 Commencement
This Specification commences on 1 January 2016.
3 Transitional Arrangements
(1) From the date of commencement of this Specification until the day 18 months after the date of commencement of this Specification, medicines in a prescribed class must comply with the requirements specified in Schedule 1 to this Specification.
Note 1: Nothing in (1) is intended to prevent a person from complying with the requirements in Schedule 2 in relation to a medicine in a prescribed class between the date of commencement of this Specification and the day 18 months after the date of that commencement, if they wish to do so.
(2) From the day 18 months after the date of commencement of this Specification, medicines in a prescribed class must comply with the requirements specified in Schedule 2 to this Specification.
4 Definitions
(1) In this Specification:
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 sale or 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 products obtained from natural raw materials either by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation. It also means:
(a) oils of equivalent composition derived through synthetic means; or
(b) compounded oils of equivalent composition comprising 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
Labelling Order means the order in force made under section 10 of the Act and published on the Federal Register of Legislative Instruments, specifying general requirements for labelling of medicines
listed medicine means a medicine that is listed in the Register under sections 26 or 26A of the Act
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 has the same meaning as in the Act
medicine in a prescribed class means medicine in a class prescribed in the Regulations for the purposes of paragraph 3(5)(ca) of the Act
MRDD (Maximum recommended daily dose) is the maximum approved dose per day for a medicine used for its main indication in adults
Regulations means the Therapeutic Goods Regulations 1990
signal heading means the signal word or words relating to the Schedule of the SUSMP in which the substance is included and the purpose for which it is to be used, as shown in the following table:
| Schedule | Purpose | Signal Words Required |
|---|---|---|
| 2 | For any purpose | PHARMACY MEDICINE |
| 3 | For any purpose | PHARMACIST ONLY MEDICINE |
| 4 | For human use | PRESCRIPTION ONLY MEDICINE |
| 5 | For any purpose | CAUTION |
| 6 | For any purpose | POISON |
| 7 | For any purpose | DANGEROUS POISON |
| 8 | For any purpose | CONTROLLED DRUG |
SUSMP means the Standard for the Uniform Scheduling of Medicines and Poisons, as set out in Schedule 1 of the current Poisons Standard
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
(2) Unless the contrary intention appears, a reference to a substance in this Specification includes:
a. that substance prepared from natural sources or artificially; and
b. where the substance is a plant (other than a plant referred to in Schedules 8 or 9 of the SUSMP), that plant or any part of that plant when packed or prepared for therapeutic use; and
c. every salt, active principle or derivative of the substance, including esters and ethers and every salt of such an active principle or derivative; and
d. every alkaloid of the substance and every salt of such an alkaloid; and
e. except where the stereoisomer is defined in the substance name (e.g. dextromethorphan), every stereoisomer of the substance and every salt of such a stereoisomer; and
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 SUSMP; or
h. a substance included in Appendix G of the SUSMP at a concentration not exceeding the concentration specified in column 2 of that Appendix in respect of the substance; or
i. any other substance included in Schedules 1 to 6 of the SUSMP, 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 of the SUSMP.
(3) Unless the contrary intention appears, where a concentration, strength or quantity is specified in this Specification in respect 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 that is listed in this Specification; and
b. the expression “one per cent” 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; and
c. in the case of codeine, such concentration, strength or quantity is calculated as anhydrous codeine.
5 Medicines Advisory Statements
The advisory statements mentioned in Schedule 1 and Schedule 2 are specified under subsection 3 (5A) of the Act for the purposes of paragraph 3(5)(ca) of the Act.
Schedule 1
Required Advisory Statements for Medicine Labels No. 2
(section 5)
Schedule 1
Required Advisory Statements for Medicine Labels No. 2
Advisory statements
Where a medicine:
1) includes a substance described in Column 1 of Table 1:Medicines to Which Advisory Statements Apply (‘the table’), below; and
2) meets the condition(s) described in Column 2 of the table;
the statement(s) set out in Column 3 of the table must be contained on the labels of the medicine in accordance with the Labelling Order, in a manner that is compliant with any applicable presentation requirement(s) set out below (the requirements are indicated in the table by the presence of the applicable alphabetical in square brackets, next to the statement or, in the case of a requirement to use upper case and/or bold face, by use of upper case and/or bold face letters in the statement itself).
Unless otherwise specified, the requirements apply only if the substance is included in the medicine as an active ingredient.
Permitted variation and combination of advisory statements
The wording of the statements specified in this document may be varied provided that the intent is not changed.
Where more than one statement is required, they may be combined to form simple sentences where appropriate, provided that the intent is not changed and that any additional requirements are also met.
Additional presentation requirements for some advisory statements
In some cases, additional requirements apply to advisory statements, such as font, letter size etc. Where such additional requirements apply, they are indicated in Column 3 of Table 1 below either by a letter in square brackets (e.g. [c]) or, in the case of a requirement to use upper case and/or bold face, by use of upper case and/or bold face letters in the statement itself. The meaning of the letters is set out below:
[c]: Statement(s) must be included at the beginning of the directions for use.
[f]: Statement(s) must be included on the label written:
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN”; and
(ii) in bold-face sanserif capital letters of uniform thickness; and
(iii) in letters as least four tenths the height of the letters used for the signal heading; and
(iv) with nothing else besides the statement written on the same line.
[g]: Statement(s), written in sanserif capital letters, must be included on the main label or as part of the directions for use.
[k]: Statement(s) must be printed in type of 3 mm height or larger.
[l]: Statement(s) must be printed on the front of the goods.
Note: Meaning of notes in Column 1 of the table
To assist sponsors to prepare for compliance with amended requirements in Schedule 2 to the Medicines Advisory Statements Specification 2016, the following Note is included in Column 1 of the table, where applicable: ‘NB: entry amended in Schedule 2’.
Table 1: Medicines to which advisory statements apply
Column 1Substance(s) Column 2Conditions Column 3Required statement(s)
Acetone In concentrations greater than 75 per cent - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSAvoid contact with eyes Avoid contact with skin Avoid breathing [vapour/spray mist]
DO NOT SWALLOW. [g]
Actaea racemosa In listed medicines - Warning: In very rare cases, Black cohosh has been associated with liver failure.
If you are experiencing yellowing of the skin or whites of the eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain, and/or loss of appetite, you should stop using this product and see your doctor.
Activated charcoal In listed medicines - Products containing activated charcoal should be used with caution in children since it may interfere with the absorption of nutrients.
Activated charcoal is not recommended for long-term use.
Ademetionine In listed medicines, in the form of sulfate salts, tosylate salts or mixed sulfate and tosylate salts - Individuals who are using prescription antidepressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner.
(S)-S-Adenosylmethionine In listed medicines, in the form of sulfate salts, tosylate salts or mixed sulfate and tosylate salts - Individuals who are using prescription antidepressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner.
Alclometasone When included in Schedule 3 to the SUSMP - CAUTION - Do not use for children under 2 years old unless a doctor has told you to.
Alpha casozepine enriched hydrolysed milk protein In listed medicines for oral ingestion - Derived from cow’s milk.
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.
Transient stinging or irritation may occur when using this product. If irritation persists, discontinue use.
Amethocaine(Entry 1 of 2) When included in Schedule 2 to the SUSMP and for dermal use - Do not apply to large areas of the body, except on the advice of a healthcare practitioner.
Amethocaine(Entry 2 of 2) For the purpose of exclusion from the schedules of the SUSMP when in dermal preparations containing 2 per cent OR LESS of total local anaesthetic substances - If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.
ammonium carbonate(Entry 1 of 2) NB: entry amended in Schedule 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.
ammonium carbonate(Entry 2 of 2) NB: entry amended in Schedule 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.
Anise oil For the purpose of exclusion from the schedules to the SUSMP when:
Unless a doctor has told you to, do not use [this product/insert name of product] 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 [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.
Aspirin (Entry 2 of 7) For the purpose of exclusion from the schedules to the SUSMP when:
Do not use [this product/insert name of product] 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 [this product/insert name of product] 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 [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.
Aspirin (Entry 4 of 7) When included in a schedule to the SUSMP and:
Do not use [this product/insert name of product] 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 [this product/insert name of product] 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 [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.
Aspirin (Entry 5 of 7) When included in a schedule to the SUSMP and:
Unless a doctor has told you to, do not use [this product/insert name of product] 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 [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.
Aspirin (Entry 6 of 7) When included in a schedule to the SUSMP and:
Unless a doctor has told you to, do not use [this product/insert name of product] 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 [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.
Atropa belladona In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness - If the condition persists after two days of treatment, seek medical advice as soon as possible.
Atropine In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness - If the condition persists after two days of treatment, seek medical advice as soon as possible.
Azadirachta indica (neem)(Entry 1 of 2) When:
in preparations containing more than 25 per cent of bay oil; and
a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure - KEEP OUT OF REACH OF CHILDREN.
NOT TO BE TAKEN
Benzocaine(Entry 1 of 3) In dermal preparations containing MORE than 2 per cent of total local anaesthetic substances - Do not apply to large areas of the body, except on the advice of a healthcare practitioner.
Benzocaine(Entry 2 of 3) In dermal preparations containing 2 per cent OR LESS of total local anaesthetic substances - If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.
Benzocaine(Entry 3 of 3) In lozenges - Do not take hot food or drink if the mouth feels numb after taking this product as it may burn the mouth.
Benzoyl peroxide In Schedule 2 to the SUSMP - 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.
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.
Bergamot oil For the purpose of exclusion from the schedules to the SUSMP; or when included in a schedule to the SUSMP - Application to skin may increase sensitivity to sunlight.
Bovine colostrum powder In listed medicines - Products containing bovine colostrum powder contain lactose and cow’s milk proteins.
Bovine lactoferrin In listed medicines - Derived from cow’s milk.
Bovine whey IG-rich fraction In listed medicines for oral ingestion - Derived from cow’s milk.
Bromhexine (Entry 1 of 2) NB: entry amended in Schedule 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.
Bromhexine (Entry 2 of 2) NB: entry amended in Schedule 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.
Brompheniramine (Entry 1 of 3) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years - 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.
Brompheniramine (Entry 2 of 3) In oral preparations indicated for cough, cold or flu which include dosage instructions for adults and children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11) - 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.
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.
Brompheniramine (Entry 3 of 3) In oral preparations indicated for cough, cold or flu which only include dosage instructions for children aged from ‘x’ 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.
Butoconazole In preparations for vaginal use - Do not use if you are pregnant.
Caffeine (Entry 1 of 2) In listed medicines, except medicines containing less than 1 milligram of caffeine in the MRDD:
in preparations or oils containing more than 25 per cent of cajuput oil; and
a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure - KEEP OUT OF REACH OF CHILDREN.
Calcium sodium caseinate In listed medicines either
Derived from cow’s milk.or
Contains cow’s milk protein.
Camphor(Entry 1 of 3) For the purpose of exclusion from the schedules to the SUSMP when:
in essential oils when the camphor is present as a natural component of the oil; and
a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure - KEEP OUT OF REACH OF CHILDREN.
SAFETY DIRECTIONSCan be fatal to children if sucked or swallowed. Avoid contact with eyes.
Canarium indicum In listed medicines - This product contains material derived from nuts.
Carthamus tinctorius In listed medicines - Do not use if pregnant or likely to become pregnant.
Cassia oil When included in a schedule to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSAvoid contact with skin.
DO NOT SWALLOW. [g]
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.
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.
Charcoal – activated In listed medicines - Products containing activated charcoal should be used with caution in children since it may interfere with the absorption of nutrients.
Activated charcoal is not recommended for long term use.
Chelidonium majus When the preparation is for oral use. - Warning: Greater Celandine may harm the liver in some people.
Chitosan(Entry 1 of 2) In listed medicines, except in oral powder dosage form. - Derived from seafood.
Chitosan(Entry 2 of 2) In listed medicines in oral powder dosage form. - Derived from seafood.
Do not take powder alone. Mix with food or fluid.
Chlorhexidine(Entry 1 of 2) In topical products, including preparations for topical use on mucosal surfaces. - Avoid contact with eyes.
WARNING – This product contains chlorhexidine. Severe allergic reactions can occur. Stop use if this occurs.
Chlorhexidine(Entry 2 of 2) In topical products OTHER THAN preparations for topical use on mucosal surfaces. - Avoid contact with eyes.
Chlorpheniramine (Entry 1 of 3) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years - 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.
Chlorpheniramine (Entry 2 of 3) In oral preparations indicated for cough, cold or flu which include dosage instructions for adults and children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11) - 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.
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.
Chlorpheniramine (Entry 3 of 3) In oral preparations indicated for cough, cold or flu which only include dosage instructions for children aged from ‘x’ 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.
Choline salicylate In preparations for topical oral use. - Do not exceed the recommended dose. Excessive or prolonged use can be harmful.
Chromates (including dichromates) of alkali metals or ammonia When included in a schedule to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSAvoid contact with eyes Avoid contact with skin Avoid breathing [dust]/[vapour]/[ spray mist].
Cimetidine NB: entry amended in Schedule 2 In Schedule 3 to the SUSMP - 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.
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.
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
Cineole For the purpose of exclusion from the schedules to the SUSMP when:
in preparations or oils containing more than 25 per cent of cineole (other than rosemary oil or camphor oil); and
a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure - KEEP OUT OF REACH OF CHILDREN.
Cinnamon bark oil When included in a schedule to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSAvoid contact with skin
DO NOT SWALLOW. [g]
Cinnamon leaf oil For the purpose of exclusion from the schedules to the SUSMP when:
in preparations containing more than 25 per cent of cinnamon leaf oil; and
a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure - KEEP OUT OF REACH OF CHILDREN.
in preparations containing more than 25 per cent of clove oil; and
a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure - KEEP OUT OF REACH OF CHILDREN.
Clove oil(Entry 2 of 2) When included in a schedule to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
DO NOT SWALLOW. [g]
Coal tar In preparations for topical use - Avoid contact with eyes.
Do not use for prolonged periods except on the advice of a doctor or pharmacist.
Codeine (Entry 1 of 2) NB: entry amended in Schedule 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.
Codeine (Entry 2 of 2) NB: entry amended in Schedule 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.
Colostrum powder – bovine In listed medicines - Products containing bovine colostrum powder contain lactose and cow’s milk proteins.
Concentrated omega-3-trigrylcerides - squid In listed medicines - DERIVED FROM SEAFOOD
Creatine In listed medicines - Seek professional advice before long term use.
Creatine monohydrate In listed medicines - Seek professional advice before long term use.
Creatine phosphate In listed medicines - Seek professional advice before long term use.
Datura spp In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness - If the condition persists after two days of treatment, seek medical advice as soon as possible.
Desloratadine In medicines for oral use - If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.
Dexchlorpheniramine (Entry 1 of 3) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years - 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.
Dexchlorpheniramine (Entry 2 of 3) In oral preparations indicated for cough, cold or flu which include dosage instructions for adults and children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11) - 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.
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.
Dexchlorpheniramine (Entry 3 of 3) In oral preparations indicated for cough, cold or flu which only include dosage instructions for children aged from ‘x’ 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.
Dextromethorphan (Entry 1 of 2) NB: entry amended in Schedule 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.
Dextromethorphan (Entry 2 of 2) NB: entry amended in Schedule 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.
Diclofenac(Entry 1 of 4) NB: entry amended in Schedule 2 In preparations for oral use when indicated exclusively for the treatment of dysmenorrhoea - Do not use [this product/insert name of product] if you have a stomach ulcer.
Do not use [this product/insert name of product] if you are allergic to diclofenac or other anti-inflammatory medicines.
Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] 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.
Diclofenac (Entry 2 of 4) NB: entry amended in Schedule 2 In preparations for oral use in adults and children aged 12 years and over, when NOT indicated exclusively for the treatment of dysmenorrhoea - Do not use [this product/insert name of product] if you have a stomach ulcer.
Do not use [this product/insert name of product] if you are allergic to diclofenac or other anti-inflammatory medicines.
Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] 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.
Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.
Diclofenac (Entry 3 of 4) NB: entry amended in Schedule 2 In preparations indicated for oral use in children under 12 years of age - Do not use [this product/insert name of product] if you have a stomach ulcer.
Do not use [this product/insert name of product] if you are allergic to diclofenac or other anti-inflammatory medicines.
Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] 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.
Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.
Diclofenac(Entry 4 of 4) 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.
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.
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.
Dihydrocodeine (Entry 1 of 2) NB: entry amended in Schedule 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.
Dihydrocodeine (Entry 2 of 2) NB: entry amended in Schedule 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.
Diphenhydramine (Entry 1 of 4) When indicated for short term use in insomnia - Not recommended for use by pregnant or breastfeeding women.
This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.
Diphenhydramine (Entry 2 of 4) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years - 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.
Diphenhydramine (Entry 3 of 4) In oral preparations indicated for cough, cold or flu which include dosage instructions for adults and children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11) - 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.
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.
Diphenhydramine (Entry 4 of 4) In oral preparations indicated for cough, cold or flu which only include dosage instructions for children aged from ‘x’ 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.
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 two days of treatment, seek medical advice as soon as possible.
Do not use during pregnancy or breastfeeding unless advised by your doctor or pharmacist.
Doxylamine (Entry 1 of 4) When indicated for short term use in insomnia - Not recommended for use by pregnant or breastfeeding women.
This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.
Doxylamine (Entry 2 of 4) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years - 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.
Doxylamine (Entry 3 of 4) In oral preparations indicated for cough, cold or flu which include dosage instructions for adults and children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11) - 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.
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.
Doxylamine (Entry 4 of 4) In oral preparations indicated for cough, cold or flu which only include dosage instructions for children aged from ‘x’ 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.
Econazole In preparations for vaginal use - Seek medical advice before first course of treatment.
Eucalyptus oil For the purpose of exclusion from the schedules to the SUSMP when:
in preparations containing more than 25 per cent of eucalyptus oil; and
a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure - KEEP OUT OF REACH OF CHILDREN.
in preparations containing more than 25 per cent of eugenol; and
a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure - KEEP OUT OF REACH OF CHILDREN.
Eugenol(Entry 2 of 2) When included in a schedule to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
DO NOT SWALLOW. [g]
Fallopia multiflora In listed medicines - Warning: Fallopia multiflora may harm the liver in some people.
Use under the supervision of a healthcare professional.
Famciclovir In medicines for oral use - If you are taking other medicines regularly, consult your pharmacist or doctor before use.
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.
Famotidine NB: entry amended in Schedule 2 In medicines for oral use - CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed.
Fexofenadine In medicines for oral use - If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.
Fluconazole In medicines for oral use - Do not use if pregnant.
Fluorides(Entry 1 of 3) For the purpose of exclusion from the schedules to the SUSMP when:
Fluorides(Entry 2 of 3) When included in a schedule to the SUSMP except oral fluoride supplements - Do not swallow.
Fluorides(Entry 3 of 3) In Schedule 2 to the SUSMP 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
Flurbiprofen(Entry 1 of 2) NB: entry amended in Schedule 2 In oral preparations that do NOT include indications for use in children under 12 years of age - Do not use [this product/insert name of product] if you have a stomach ulcer.
Do not use [this product/insert name of product] if you are allergic to flurbiprofen or other anti-inflammatory medicines.
Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] 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.
Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.
Flurbiprofen(Entry 2 of 2) NB: entry amended in Schedule 2 In oral preparations that include indications for use in children under 12 years of age - Do not use [this product/insert name of product] if you have a stomach ulcer.
Do not use [this product/insert name of product] if you are allergic to flurbiprofen or other anti-inflammatory medicines.
Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] 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.
Do not use [this product/insert name of product] 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.
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.
Glucosamine hydrochloride In listed medicines, when derived from a marine source - Derived from seafood.
Glucosamine sulfate In listed medicines, when derived from a marine source - Derived from seafood.
Glucosamine sulfate potassium chloride complex(Entry 1 of 2) In listed medicines, when derived from a marine source - Derived from seafood.
Glucosamine sulfate potassium chloride complex(Entry 2 of 2) In listed medicines for oral use - Keep out of reach of children.
If you have kidney disease or are taking heart or blood pressure medicines, consult your doctor or pharmacist before use.
Glucosamine sulfate sodium chloride complex In listed medicines, when derived from a marine source - Derived from seafood.
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.
Guaifenesin (Guaiphenesin)(Entry 1 of 2) NB: entry amended in Schedule 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.
Guaifenesin (Guaiphenesin)(Entry 2 of 2) NB: entry amended in Schedule 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.
Hexachlorophane In preparations for skin cleansing purposes containing 3 per cent or less of hexachlorophane. - For external washing only.
Rinse skin thoroughly after use.
High selenium yeast In listed medicines - This product contains selenium which is toxic in high doses
Honey In listed medicines - Not suitable for infants under 12 months.
Hydrocortisone(Entry 1 of 2) In preparations for dermal use - CAUTION - do not use for children under 2 years old unless a doctor has told you to.
Hydrocortisone(Entry 2 of 2) In preparations for topical rectal use - CAUTION - do not use for children under 2 years old unless a doctor has told you to.
Hydrofluoric acid (including mixtures that generate hydrofluoric acid)(Entry 1 of 2) In Schedule 5 to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSCorrosive Avoid contact with eyes Avoid contact with skin.
DO NOT SWALLOW. [g]
Hydrofluoric acid (including mixtures that generate hydrofluoric acid)(Entry 2 of 2) In Schedule 6 or Schedule 7 to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING [f]
SAFETY DIRECTIONSHighly corrosive Contact with eyes even for short periods can cause blindness Causes severe burns, which are not likely to be immediately painful or visible Avoid contact with eyes Avoid contact with skin Wear protective gloves when mixing or using Avoid breathing [dust/vapour/spray mist] Obtain a supply of calcium gluconate gel.
Hydrogen peroxide(Entry 1 of 3) In concentrations of more than 3 per cent up to 10 per cent - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSIrritant Avoid contact with eyes.
DO NOT SWALLOW. [g]
Hydrogen peroxide(Entry 2 of 3) In concentrations of more than 10 per cent up to 20 per cent - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSIrritant Attacks eyes - protect eyes when using.
Hydrogen peroxide(Entry 3 of 3) In concentrations of more than 20 per cent. - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSCorrosive Attacks eyes - protect eyes when using Avoid contact with skin.
Hydrolysed milk protein – alpha casozepine enriched In listed medicines for oral ingestion. - Derived from cow’s milk.
This product is not suitable for use in children under the age of 12 months except on professional health advice
Hydroquinone In Schedule 2 to the SUSMP - 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.
If fading is not evident in three months, seek doctor’s advice.
Do not exceed recommended dose. Excessive or prolonged use should be avoided because darkening of the skin can occur.
Senna(Entry 1 of 3) Where the MRDD contains MORE than 10 milligrams and the product IS promoted or marketed as a laxative - Not recommended for use by children under 12 years of age.
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.
Senna(Entry 2 of 3) Where the MRDD contains MORE than 10 milligrams and the product IS NOT promoted or marketed as a laxative - Not recommended for use by children under 12 years of age.
This product may have a laxative effect.
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)].
Senna(Entry 3 of 3) Where the MRDD contains 10 milligrams OR LESS and the product IS promoted or marketed as laxative - Not recommended for use by children under 12 years of age.
8-Hydroxyquinoline (including salts and derivatives) In preparations for internal use - Do not take for periods longer than four weeks except on medical advice.
Hyoscine In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness - If the condition persists after two days of treatment, seek medical advice as soon as possible.
Hyoscyamine In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness - If the condition persists after two days of treatment, seek medical advice as soon as possible.
Do not use during pregnancy or breastfeeding unless advised by your doctor or pharmacist
Hyoscyamus niger In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness - If the condition persists after two days of treatment, seek medical advice as soon as possible.
Hypericum perforatum In listed medicines for oral use - St John’s Wort affects the way many prescription medicines work, including oral contraceptives.
Consult your doctor.
Ibuprofen(Entry 1 of 6) NB: entry amended in Schedule 2 In preparations for oral use when indicated exclusively for the treatment of dysmenorrhoea - Do not use [this product/insert name of product] if you have a stomach ulcer.
Do not use [this product/insert name of product] if you are allergic to ibuprofen or other anti-inflammatory medicines.
Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] 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.
Ibuprofen(Entry 2 of 6) NB: entry amended in Schedule 2 For the purpose of exclusion from the schedules to the SUSMP, when the preparation is for oral use and:
Do not use [this product/insert name of product] if you are allergic to ibuprofen or other anti-inflammatory medicines.
Do not use [this product/insert name of product] 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 advised by your doctor or pharmacist, do not use [this product/insert name of product] 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.
Ketoprofen(Entry 3 of 4) NB: entry amended in Schedule 2 When the preparation is for oral use and includes indications for use in children under 12 years of age - Do not use [this product/insert name of product] if you have a stomach ulcer.
Do not use [this product/insert name of product] if you are allergic to ibuprofen or other anti-inflammatory medicines.
Do not use [this product/insert name of product] 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 advised by your doctor or pharmacist, do not use [this product/insert name of product] 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.
Ketoprofen(Entry 4 of 4) 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.
Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly.
Kunzea ambigua (Entry 1 of 2) In listed medicines when the preparation is “essential oil” - For external use only.
Not to be applied undiluted to the skin except on the advice of a healthcare practitioner.
Kunzea ambigua (Entry 2 of 2) In listed medicines when the preparation is other than “essential oil” - For external use only.
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
Lactoferrin – bovine In listed medicines - Derived from cow’s milk.
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.
Larrea tridentata In listed medicines - Warning: Chaparral may harm the liver in some people.
Lemon oil For the purpose of exclusion from the schedules of the SUSMP - Application to skin may increase sensitivity to sunlight.
Leptospermum scoparium oil For the purpose of exclusion from the schedules to the SUSMP when:
in preparations containing more than 25 per cent of Leptospermum scoparium oil; and
a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure - KEEP OUT OF REACH OF CHILDREN.
Levocabastine(Entry 1 of 2) In eye or nasal preparations containing 0.5 milligrams/millilitre or less of levocabastine - Do not use if pregnant.
Levocabastine(Entry 2 of 2) In eye or nasal preparations containing MORE THAN 0.5 milligrams per millilitre 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.
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.
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.
Lignocaine(Entry 1 of 3) In dermal preparations containing MORE THAN 2 per cent of total local anaesthetic substances - Do not apply to large areas of the body, except on the advice of a healthcare practitioner.
Lignocaine(Entry 2 of 3) In dermal preparations containing 2 per cent OR LESS of total local anaesthetic substances - If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.
Lignocaine(Entry 3 of 3) In lozenges - Do not take hot food or drink if the mouth feels numb after taking this product as it may burn the mouth.
Lime oil For the purpose of exclusion from the schedules of the SUSMP - Application to skin may increase sensitivity to sunlight.
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.
Loperamide hydrochloride In medicines for oral use - If the condition persists after two days of treatment, seek medical advice as soon as possible.
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.
Loratadine In medicines for oral use - If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.
Marjoram oil For the purpose of exclusion from the schedules to the SUSMP when:
in preparations containing more than 25 per cent of melaleuca oil; and
when packed in containers having:
a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure - KEEP OUT OF REACH OF CHILDREN.
Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] 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.
Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.
Naproxen (Entry 3 of 3) NB: entry amended in Schedule 2 When the preparation includes indications for oral use in children under 12 years of age - Do not use [this product/insert name of product] if you have a stomach ulcer.
Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] 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.
Do not use [this product/insert name of product] 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.
Nasal decongestant preparations, including:
Methoxamine
Xylometazoline NB: entry amended in Schedule 2 When in nasal decongestant preparations for topical use - If congestion persists, consult your doctor or pharmacist.
Nizatidine NB: entry amended in Schedule 2 In medicines for oral use - CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed.
Nutmeg oil For the purpose of exclusion from the schedules to the SUSMP when:
Nystatin In preparations for vaginal use - See a doctor if you are pregnant or diabetic.
If getting better, keep using for [insert number of days as per approved Product Information] days.
Omega-3 fish oil phytosterol esters When in listed medicines for oral ingestion - Not suitable for use by pregnant or lactating women.
There is no benefit from taking more than 3 g per day of phytosterols from all sources.
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.
Orange oil (bitter) For the purpose of exclusion from the schedules to the SUSMP - Application to skin may increase sensitivity to sunlight.
Oxymetazoline(Entry 1 of 4) NB: entry amended in Schedule 2 In nasal decongestant preparations for topical use - If congestion persists, consult your doctor or pharmacist.
Oxymetazoline(Entry 2 of 4)(See also vasoconstrictor eye drops) In topical eye preparations - Prolonged use may be harmful.
Oxymetazoline (Entry 3 of 4) NB: entry amended in Schedule 2 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.
Oxymetazoline (Entry 4 of 4) NB: entry amended in Schedule 2 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.
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.
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.
Paracetamol(Entry 1 of 2) For the purpose of exclusion from the schedules to the SUSMP - 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.
Paracetamol(Entry 2 of 2) In Schedule 2 or 3 to the SUSMP - - 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. and / or- 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.
Paullinia cupana In listed medicines - The goods contain caffeine.
Each [insert name of dosage unit] contains [insert quantity] of caffeine.
Pennyroyal oil For the purpose of exclusion from the schedules to the SUSMP when:
Pentoxyverine (Entry 1 of 2) NB: entry amended in Schedule 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.
Pentoxyverine (Entry 2 of 2) NB: entry amended in Schedule 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.
Permanganates (see also Potassium permanganate) When included in Schedule 6 to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSCorrosive Avoid contact of the crystals or strong solutions with the eyes, mouth, nose and other mucous membranes.
Pheniramine (Entry 1 of 3) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years - either
This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.
Pheniramine (Entry 2 of 3) In oral preparations indicated for cough, cold or flu which include dosage instructions for adults and children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11) - 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.
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.
Pheniramine (Entry 3 of 3) In oral preparations indicated for cough, cold or flu which only include dosage instructions for children aged from ‘x’ 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.
Phenol and any other homologue of phenol When included in Schedule 2 to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
DO NOT SWALLOW. [g]
Phenylalanine In listed medicines for oral or sublingual administration, the MRDD of which contains more than 500 milligrams of phenylalanine - Do not use if pregnant or likely to become pregnant.
Phenylephrine(Entry 1 of 7) NB: entry amended in Schedule 2 In nasal decongestant preparations for topical use - If congestion persists, consult your doctor or pharmacist.
Phenylephrine(Entry 2 of 7)(See also vasoconstrictor eye drops) In topical eye preparations - Prolonged use may be harmful.
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.
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.
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.
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.
Phenylephrine Entry 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.
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.
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.
Pholcodine (Entry 1 of 2) NB: entry amended in Schedule 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.
Pholcodine (Entry 2 of 2) NB: entry amended in Schedule 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.
Piper methysticum(Entry 1 of 2) In listed medicines for oral use containing more than 25 mg of kavalactones per dose - Not recommended for use by pregnant or lactating women.
WARNING: Not for prolonged use.
Piper methysticum(Entry 2 of 2) For the purpose of exclusion from the schedules to the SUSMP in medicines for oral use - Not recommended for use by pregnant or lactating women
WARNING: Not for prolonged use
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.
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.
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.
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.
Pollen When the ingredient is collected by bees and included in listed medicines (including as an excipient). - This product contains pollen which can cause severe allergic reactions.
Potassium chloride(Entry 1 of 2) In listed medicines for oral rehydration therapy exclusively for adults - Keep out of reach of children.
If you have kidney disease or are taking heart or blood pressure medicines, consult your doctor or pharmacist before use.
Potassium chloride(Entry 2 of 2) In listed medicines for oral rehydration therapy and indicated for use in children - Keep out of reach of children.
If you have kidney disease or are taking heart or blood pressure medicines, consult your doctor or pharmacist before use.
Potassium hydroxide(Entry 1 of 3) When included in a schedule to the SUSMP, in preparations containing 0.5 per cent OR LESS of potassium hydroxide - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSIrritant Avoid contact with eyes Avoid contact with skin Wash hands after use.
DO NOT SWALLOW. [g]
Potassium hydroxide(Entry 2 of 3) When included in a schedule to the SUSMP, in solid preparations containing MORE THAN 0.5 per cent of potassium hydroxide - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSCorrosive May produce severe burns Attacks skin and eyes Wear eye protection when mixing or using Wear protective gloves when mixing or using Do not mix with hot water.
Potassium hydroxide(Entry 3 of 3) When included in a schedule to the SUSMP, in liquid preparations containing MORE THAN 0.5 per cent of potassium hydroxide - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSCorrosive May produce severe burns Attacks skin and eyes Wear eye protection when mixing or using Wear protective gloves when mixing or using.
Potassium permanganate In Schedule 6 to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSCorrosive Avoid contact of the crystals or strong solutions with the eyes, mouth, nose and other mucous membranes.
Povidone-iodine In preparations for dermal use - If skin irritation or rash occurs, discontinue use immediately.
Promethazine (Entry 1 of 4) When indicated for short term use in insomnia - Not recommended for use by pregnant or breastfeeding women.
This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.
Promethazine (Entry 2 of 4) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years - 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.
Promethazine (Entry 3 of 4) In oral preparations indicated for cough, cold or flu which include dosage instructions for adults and children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11) - 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.
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.
Promethazine (Entry 4 of 4) In oral preparations indicated for cough, cold or flu which only include dosage instructions for children aged from ‘x’ 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.
Propolis(Entry 1 of 2) In listed medicines for internal use - WARNING: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs - discontinue use.
Propolis(Entry 2 of 2) In listed medicines for external use - WARNING: Propolis may cause skin irritation. Test before use.
Proton pump inhibitors including:
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.
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.
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.
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.
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.
Psyllium In medicines for oral ingestion which include dosage instructions for children - Should only be used for children on medical advice.
Pyrethrins When used as an excipient in listed medicines for topical use - This product contains pyrethrins [insert quantity]
Pyridoxal(see also Vitamin B6, Vitamins)(Entry 1 of 2) In SINGLE-INGREDIENT preparations containing 200 milligrams or less but more than 50 milligrams 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.
Pyridoxal(see also Vitamin B6, Vitamins)(Entry 2 of 2) In MULTI-INGREDIENT preparations containing 200 milligrams or less but more than 50 milligrams 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.
Pyridoxine(see also Vitamin B6, Vitamins)(Entry 1 of 2) In SINGLE- INGREDIENT preparations containing 200 milligrams or less but more than 50 milligrams 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.
Pyridoxine(see also Vitamin B6, Vitamins)(Entry 2 of 2) In MULTI-INGREDIENT preparations containing 200 milligrams or less but more than 50 milligrams 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 B.
Pyrithione zinc In preparations for external use for treatment of the scalp either
Keep out of eyes.or
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.
Ranitidine NB: entry amended in Schedule 2 Medicines for oral use - CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed.
Royal jelly In listed medicines - Not suitable for use by children.
This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities - especially in asthma and allergy suffers.
Safrole When included in a schedule to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Sage oil For the purpose of exclusion from the schedules to the SUSMP when:
Salbutamol In metered aerosols or in dry powder formulations - This preparation should be part of an overall treatment plan regularly assessed with your doctor.
Sassafras oil When included in a schedule to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Selenium yeast – high In listed medicines - This product contains selenium which is toxic in high doses.
Selenocysteine In listed medicines - This product contains selenium which is toxic in high doses.
Selenomethionine In listed medicines - This product contains selenium which is toxic in high doses.
Senega (Entry 1 of 2) NB: entry amended in Schedule 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.
Senega (Entry 2 of 2) NB: entry amended in Schedule 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.
Shark cartilage In listed medicines - Children, pregnant or breastfeeding women, and those who have recently had a heart attack, surgery or a major accident should not consume this product without medical advice.
Silver(see also Silver salts) For the purpose of exclusion from the schedules to the SUSMP when:
Silver salts(see also Silver) In smoking deterrents. - WARNING - Overuse may stain the skin or mouth.
Sodium bicarbonate(Entry 1 of 2) In listed medicines for oral rehydration therapy exclusively for adults - Use only as directed.
Sodium bicarbonate(Entry 2 of 2) In listed medicines for oral rehydration therapy that are indicated for use in children - Use only as directed.
Sodium fluoride(see also Fluorides) In preparations for ingestion when in Schedule 2 to the SUSMP - Use of this product is not necessary in areas supplied with fluoridated water.
Sodium hydroxide(Entry 1 of 3) When included in a schedule to the SUSMP, in preparations containing 0.5 per cent or less of sodium hydroxide - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSIrritant Avoid contact with eyes Avoid contact with skin Wash hands after use. - DO NOT SWALLOW. [g]
Sodium hydroxide(Entry 2 of 3) When included in a schedule to the SUSMP, in solid preparations containing more than 0.5 per cent of sodium hydroxide - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSCorrosive May produce severe burns Attacks skin and eyes Wear eye protection when mixing or using Wear protective gloves when mixing or using Do not mix with hot water.
Sodium hydroxide(Entry 3 of 3) When included in a schedule to the SUSMP, in liquid preparations containing more than 0.5 per cent of sodium hydroxide - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSCorrosive May produce severe burns Attacks skin and eyes Wear eye protection when mixing or using Wear protective gloves when mixing or using.
Sodium selenate In listed medicines - This product contains selenium which is toxic in high doses.
Sodium selenite In listed medicines - This product contains selenium which is toxic in high doses.
Sodium sulfate In listed medicines - This preparation may have a laxative effect.
Squid oil In listed medicines - DERIVED FROM SEAFOOD
(S)-S-Adenosylmethionine In listed medicines, in the form of sulfate salts, tosylate salts or mixed sulfate and tosylate salts - Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner.
Star anise oil For the purpose of exclusion from the schedules to the SUSMP when:
Sugar cane wax alcohols In listed medicines - Not recommended for use by pregnant or lactating women.
Symphytum spp In Schedule 5 to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSDo not use on broken skin Do not use under occlusive dressing. - DO NOT SWALLOW. [g]
Terbutaline In metered aerosols - This preparation should be part of an overall treatment plan regularly assessed with your doctor.
Tetrahydrozoline (Entry 1 of 2) NB: entry amended in Schedule 2 In nasal decongestant preparations for topical use - If congestion persists, consult your doctor or pharmacist.
Tetrahydrozoline (Entry 2 of 2)(See also vasoconstrictor eye drops) In topical eye preparations - Prolonged use may be harmful.
Thyme oil For the purpose of exclusion from the schedules to the SUSMP when:
Tioconazole In preparations for vaginal use - Do not use if you are pregnant.
Tramazoline(entry 1 of 2) NB: entry amended in Schedule 2 In nasal decongestant preparations for topical use - If congestion persists, consult your doctor or pharmacist.
Tramazoline (Entry 2 of 2)(See also vasoconstrictor eye drops) In topical eye preparations - Prolonged use may be harmful.
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].
Triprolidine(Entry 1 of 3) In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years - 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.
Triprolidine(Entry 2 of 3) In oral preparations indicated for cough, cold or flu which include dosage instructions for adults and children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11) - 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.
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.
Triprolidine(Entry 3 of 3) In oral preparations indicated for cough, cold or flu which only include dosage instructions for children aged from ‘x’ 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.
Tymazoline(Entry 1 of 2) NB: entry amended in Schedule 2 In nasal decongestant preparations for topical use - If congestion persists, consult your doctor or pharmacist.
Tymazoline(Entry 2 of 2)(See also Vasoconstrictor eye drops) In topical eye preparations - Prolonged use may be harmful.
Ubidecarenone In listed medicines - Not to be taken, if on warfarin therapy, without medical advice.
Ubiquinol-10 In listed medicines - Not to be taken, if on warfarin therapy, without medical advice.
Vasoconstrictor eye drops including:
Xylometazoline In topical eye preparations - Prolonged use may be harmful.
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.
Vitamin A(See also Vitamins) In medicines for oral use that are labelled to be used by females of childbearing age containing MORE THAN:
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]
pyridoxine(Entry 1 of 2)(See also Vitamins) In SINGLE- INGREDIENT preparations containing 200 milligrams or less but more than 50 milligrams 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.
pyridoxine (Entry 2 of 2)(See also Vitamins) In MULTI-INGREDIENT preparations containing 200 milligrams or less but more than 50 milligrams 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.
Vitamins(see also:Pyridoxal, Pyridoxine,Vitamin A, Vitamin B6) In listed medicines either
Vitamins can only be of assistance if the dietary vitamin intake is inadequate.or
Vitamin supplements should not replace a balanced diet.
Wheat dextrin When used as an excipient in listed medicines for oral use - Contains gluten.
Xylometazoline(Entry 1 of 4) NB: entry amended in Schedule 2 When in nasal decongestant preparations for topical use - If congestion persists, consult your doctor or pharmacist.
Xylometazoline(Entry 2 of 4)(See also Vasoconstrictor eye drops) In topical eye preparations - Prolonged use may be harmful.
Xylometazoline (Entry 3 of 4) NB: entry amended in Schedule 2 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.
Xylometazoline (Entry 4 of 4) NB: entry amended in Schedule 2 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.
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.
Yeast – high selenium In listed medicines - This product contains selenium which is toxic in high doses.
Zinc chloride In a schedule to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Zinc compounds In preparations for internal use with a recommended daily dose of more than 25 milligrams 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.
Zinc sulfate In Schedule 6 to the SUSMP - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Zingiber officinale In listed medicines:
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
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Therapeutic Goods Act 1989
I, Mary McDonald, First Assistant Secretary, Medicines Regulation of the Regulatory Services Group and delegate of the Minister for Health, make this Specification under subsection 3(5A) of the Therapeutic Goods Act 1989.
Dated this 24 day of November 2015
(Signed by)
Mary McDonald
Delegate of the Minister for Health
Introduction
This Specification sets out advisory statements that are required to be included on the labels of medicines to which the Specification applies, if they contain particular ingredients (in most cases, this relates to active ingredients only).
The advisory statements set out in the Specification are designed to address specific risks related to the use of medicines that have been identified via pharmacovigilance activities, testing, adverse event reports or other scientific or clinical information.
Having advisory statements on medicine labels therefore ensures that consumers are informed about these risks.
It is important to note that medicines that are mentioned in Part 1 of Schedule 10 to the Regulations – which are comprised of prescription medicines and medicines such as medical gasses, radiopharmaceuticals and dialysis solutions – are not required to comply with the Specification.
The exclusion of these products reflects that access to prescription medicines is controlled by registered medical practitioners, and that information about the potential benefits and risks of a medicine is part of the consultation between patient and prescriber rather than needing to be included on a medicine’s label. Also, the risk-benefit profile of such medicines may vary considerably from patient to patient.
In relation to radiopharmaceuticals and the like, in most cases these are not supplied directly to consumers but are utilised in a treatment setting such as a hospital.
In addition to the above, medicines that are not mentioned in Part 1 of Schedule 10 to the Regulations but for which the Secretary or her delegate has consented to their import, supply or export notwithstanding that they do not comply with a requirement to include an advisory statement on their label (and which comply with the terms of that consent), will also not be required to comply with the Specification.
1 Name of Specification
This Specification is the Medicines Advisory Statements Specification 2016
2 Commencement
This Specification commences on 1 January 2016.
3 Transitional Arrangements
(1) From the date of commencement of this Specification until the day 18 months after the date of commencement of this Specification, medicines in a prescribed class must comply with the requirements specified in Schedule 1 to this Specification.
Note 1: Nothing in (1) is intended to prevent a person from complying with the requirements in Schedule 2 in relation to a medicine in a prescribed class between the date of commencement of this Specification and the day 18 months after the date of that commencement, if they wish to do so.
(2) From the day 18 months after the date of commencement of this Specification, medicines in a prescribed class must comply with the requirements specified in Schedule 2 to this Specification.
4 Definitions
(1) In this Specification:
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 sale or 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 products obtained from natural raw materials either by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation. It also means:
(a) oils of equivalent composition derived through synthetic means; or
(b) compounded oils of equivalent composition comprising 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
Labelling Order means the order in force made under section 10 of the Act and published on the Federal Register of Legislative Instruments, specifying general requirements for labelling of medicines
listed medicine means a medicine that is listed in the Register under sections 26 or 26A of the Act
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 has the same meaning as in the Act
medicine in a prescribed class means medicine in a class prescribed in the Regulations for the purposes of paragraph 3(5)(ca) of the Act
MRDD (Maximum recommended daily dose) is the maximum approved dose per day for a medicine used for its main indication in adults
Regulations means the Therapeutic Goods Regulations 1990
signal heading means the signal word or words relating to the Schedule of the SUSMP in which the substance is included and the purpose for which it is to be used, as shown in the following table:
| Schedule | Purpose | Signal Words Required |
|---|---|---|
| 2 | For any purpose | PHARMACY MEDICINE |
| 3 | For any purpose | PHARMACIST ONLY MEDICINE |
| 4 | For human use | PRESCRIPTION ONLY MEDICINE |
| 5 | For any purpose | CAUTION |
| 6 | For any purpose | POISON |
| 7 | For any purpose | DANGEROUS POISON |
| 8 | For any purpose | CONTROLLED DRUG |
SUSMP means the Standard for the Uniform Scheduling of Medicines and Poisons, as set out in Schedule 1 of the current Poisons Standard
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
(2) Unless the contrary intention appears, a reference to a substance in this Specification includes:
a. that substance prepared from natural sources or artificially; and
b. where the substance is a plant (other than a plant referred to in Schedules 8 or 9 of the SUSMP), that plant or any part of that plant when packed or prepared for therapeutic use; and
c. every salt, active principle or derivative of the substance, including esters and ethers and every salt of such an active principle or derivative; and
d. every alkaloid of the substance and every salt of such an alkaloid; and
e. except where the stereoisomer is defined in the substance name (e.g. dextromethorphan), every stereoisomer of the substance and every salt of such a stereoisomer; and
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 SUSMP; or
h. a substance included in Appendix G of the SUSMP at a concentration not exceeding the concentration specified in column 2 of that Appendix in respect of the substance; or
i. any other substance included in Schedules 1 to 6 of the SUSMP, 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 of the SUSMP.
(3) Unless the contrary intention appears, where a concentration, strength or quantity is specified in this Specification in respect 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 that is listed in this Specification; and
b. the expression “one per cent” 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; and
c. in the case of codeine, such concentration, strength or quantity is calculated as anhydrous codeine.
5 Medicines Advisory Statements
The advisory statements mentioned in Schedule 1 and Schedule 2 are specified under subsection 3 (5A) of the Act for the purposes of paragraph 3(5)(ca) of the Act.
Schedule 1
Required Advisory Statements for Medicine Labels No. 2
(section 5)
Schedule 1
Required Advisory Statements for Medicine Labels No. 2
Advisory statements
Where a medicine:
1) includes a substance described in Column 1 of Table 1:Medicines to Which Advisory Statements Apply (‘the table’), below; and
2) meets the condition(s) described in Column 2 of the table;
the statement(s) set out in Column 3 of the table must be contained on the labels of the medicine in accordance with the Labelling Order, in a manner that is compliant with any applicable presentation requirement(s) set out below (the requirements are indicated in the table by the presence of the applicable alphabetical in square brackets, next to the statement or, in the case of a requirement to use upper case and/or bold face, by use of upper case and/or bold face letters in the statement itself).
Unless otherwise specified, the requirements apply only if the substance is included in the medicine as an active ingredient.
Permitted variation and combination of advisory statements
The wording of the statements specified in this document may be varied provided that the intent is not changed.
Where more than one statement is required, they may be combined to form simple sentences where appropriate, provided that the intent is not changed and that any additional requirements are also met.
Additional presentation requirements for some advisory statements
In some cases, additional requirements apply to advisory statements, such as font, letter size etc. Where such additional requirements apply, they are indicated in Column 3 of Table 1 below either by a letter in square brackets (e.g. [c]) or, in the case of a requirement to use upper case and/or bold face, by use of upper case and/or bold face letters in the statement itself. The meaning of the letters is set out below:
[c]: Statement(s) must be included at the beginning of the directions for use.
[f]: Statement(s) must be included on the label written:
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN”; and
(ii) in bold-face sanserif capital letters of uniform thickness; and
(iii) in letters as least four tenths the height of the letters used for the signal heading; and
(iv) with nothing else besides the statement written on the same line.
[g]: Statement(s), written in sanserif capital letters, must be included on the main label or as part of the directions for use.
[k]: Statement(s) must be printed in type of 3 mm height or larger.
[l]: Statement(s) must be printed on the front of the goods.
Note: Meaning of notes in Column 1 of the table
To assist sponsors to prepare for compliance with amended requirements in Schedule 2 to the Medicines Advisory Statements Specification 2016, the following Note is included in Column 1 of the table, where applicable: ‘NB: entry amended in Schedule 2’.
Table 1: Medicines to which advisory statements apply
Column 1Substance(s) Column 2Conditions Column 3Required statement(s)
Acetone In concentrations greater than 75 per cent - either- READ SAFETY DIRECTIONS [f]or- READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
SAFETY DIRECTIONSAvoid contact with eyes Avoid contact with skin Avoid breathing [vapour/spray mist]
DO NOT SWALLOW. [g]
Actaea racemosa In listed medicines - Warning: In very rare cases, Black cohosh has been associated with liver failure.
If you are experiencing yellowing of the skin or whites of the eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain, and/or loss of appetite, you should stop using this product and see your doctor.
Activated charcoal In listed medicines - Products containing activated charcoal should be used with caution in children since it may interfere with the absorption of nutrients.
This substance may interact with other medicines.
Activated charcoal is not recommended for long-term use.
Ademetionine In listed medicines, in the form of sulfate salts, tosylate salts or mixed sulfate and tosylate salts - Individuals who are using prescription antidepressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner.
(S)-S-Adenosylmethionine In listed medicines, in the form of sulfate salts, tosylate salts or mixed sulfate and tosylate salts - Individuals who are using prescription antidepressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner.
Alclometasone When included in Schedule 3 to the SUSMP - 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 told you to.
Do not use for more than 7 days unless a doctor has told you to.
Alpha casozepine enriched hydrolysed milk protein In listed medicines for oral ingestion - Derived from cow’s milk.
This product is not suitable for use in children under the age of 12 months except on professional health advice.
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.
Amethocaine(Entry 1 of 2) When included in Schedule 2 to the SUSMP 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 u
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