First scheduleFirst schedule

First schedule

Excipients required to be declared on the label of medicines

Reference to an excipient in this Schedule includes all salts and derivatives of the excipient. Ingredient names listed in column three of the table are indicative and do not constitute a complete or formal list.

The table below identifies those routes of administration where, for the purposes of the First Schedule, the ingredients must be declared.

Label Australian Approved Names (Label-AAN) have been created for certain excipients that have similar characteristics; grouping provides for the use of the ‘Label-AAN’
on the label where two or more of the ingredients in the group are present in the formulation. Presentation on the label should be in the form ‘contains (label-AAN)’.

<table cellspacing="0" cellpadding="0" style="width:98.18%; margin-left:0.25pt; border:0.75pt solid #000000"><thead><tr><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Column 1</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Column 2</span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Column 3</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Column 4</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Column 5</span></p></td></tr><tr style="height:25.35pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Ingredient Group or Name</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Conditions and Special Labelling Requirements</span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Ingredient Name(s)</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Declaration Required for Routes of Administration</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Grouping Name (Label-AAN)</span></p></td></tr></thead><tbody><tr style="height:18.05pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Aspartame</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Aspartame</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Oral</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Benzoic acid</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Benzoic acid</span><br><span>Calcium benzoate</span><br><span>Potassium benzoate</span><br><span>Sodium benzoate</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>All</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Benzoates</span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Ethanol</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt"><span style="font-size:10pt; font-weight:bold">Condition:</span><span style="font-size:10pt"> Where present in a concentration of 3% v/v or more.</span><br><span style="font-size:10pt; font-weight:bold">Requirement:</span><span style="font-size:10pt"> It shall be considered sufficient compliance with </span><a href="file:///y:\docs\html\tgo\tgo69_1.htm#32" style="text-decoration:none"><span style="font-size:10pt; color:#000000">clause 3(2)(d)</span></a><span style="font-size:10pt"> of this Order to use the statement ‘Contains alcohol’.</span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Ethanol</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>All</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Alcohol</span></p></td></tr><tr style="height:14.2pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Galactose</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Galactose</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Oral</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt"><span style="font-size:10pt">Gluten or excipients derived from gluten-containing grains (See also </span><a href="file:///y:\docs\html\tgo\tgo69_2.htm#note1%23note1" style="text-decoration:none"><span style="font-size:10pt; color:#000000">Note 1</span></a><span style="font-size:10pt">)*</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Condition:</span><span> Where gluten or an excipient derived from gluten-containing grains is present.</span><br><span style="font-weight:bold">Requirement:</span><span> To declare the source of the gluten ie the gluten-containing excipient eg wheat starch, on the label.</span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Gluten</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>All; other than skin and mucous membrane applications</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Hydroxybenzoic acid esters</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Ethyl hydroxybenzoate</span><br><span>Methyl hydroxybenzoate</span><br><span>Propyl hydroxybenzoate</span><br><span>Sodium ethyl hydroxybenzoate</span><br><span>Sodium methyl hydroxybenzoate</span><br><span>Sodium propyl hydroxybenzoate</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>All</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Hydroxybenzoates</span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Lactose</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Condition:</span><span> Where present, not withstanding</span><br><span>the entry for lactose under ‘Sugars -Monosaccharides and disaccharides’.</span><br><span style="font-weight:bold">Requirement:</span><span> To declare the presence of lactose on the label; and</span><br><span style="font-weight:bold">Condition:</span><span> Lactose forms part of total sugars for the purposes of determining if the sugars will have a significant glycaemic effect and for calculating the total daily dose.</span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Lactose</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Oral</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Peanuts and peanut products</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>All</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Phenylalanine</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Phenylalanine</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>All; other than skin and mucous membrane applications</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Pollen -Bee</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Pollen</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Oral</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Propolis</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Propolis</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Oral</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Royal Jelly</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Royal Jelly</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Oral</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Saccharin</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Saccharin</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Oral</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; page-break-after:avoid; font-size:10pt"><span>Sodium salts</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; page-break-after:avoid; font-size:10pt"><span style="font-weight:bold">Condition:</span><span> Where the total sodium content of the formulation is greater than 120 mg of sodium per maximum recommended daily dose.</span><br><span style="font-weight:bold">Requirement:</span><span> To declare the quantity of sodium per maximum recommended daily dose on the label.</span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; page-break-after:avoid; font-size:10pt"><span>Sodium bicarbonate</span><br><span>Sodium chloride</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; page-break-after:avoid; font-size:10pt"><span>Oral</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; page-break-after:avoid; font-size:10pt"><span>Sodium salts</span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Sorbic acid</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Potassium sorbate</span><br><span>Sorbic acid</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>All</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Sorbates</span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Sugar alcohols</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Condition:</span><span> Where the total sugar alcohol content of the formulation exceeds 2 g per maximum recommended daily dose.</span><br><span style="font-weight:bold">Requirement:</span><span> To declare on the label the quantity of sugar alcohols present per recommended maximum daily dose; and a statement ‘Products containing (name of sugar alcohol) may have a laxative effect or cause diarrhoea’.</span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Isomalt</span><br><span>Lactitol</span><br><span>Maltitol</span><br><span>Mannitol</span><br><span>Sorbitol</span><br><span>Xylitol</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Oral</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt"><span style="font-size:10pt">Sugars - Monosaccharides and disaccharides (See also </span><a href="file:///y:\docs\html\tgo\tgo69_2.htm#note2%23note2" style="text-decoration:none"><span style="font-size:10pt; color:#000000">Note 2</span></a><span style="font-size:10pt">)</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span style="font-weight:bold">Condition:</span><span> Where the presence of sugars may have a significant glycaemic effect and the total sugar content (including lactose which requires a separate declaration) exceeds 100mg per recommended daily dose.</span><br><span style="font-weight:bold">Requirement:</span><span> To declare the presence of certain sugars on the label.</span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Glucose</span><br><span>Honey (as a mixture of sugars)</span><br><span>Invert sugar</span><br><span>Lactose</span><br><span>Maltose</span><br><span>Sucrose</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Oral</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Sugars</span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Sulfite, metabisulfite and bisulfite salts and sulfur dioxide</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Sulfur dioxide</span><br><span>Potassium metabisulfite</span><br><span>Sodium metabisulfite</span><br><span>Sodium sulfite</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>All</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Sulfites</span></p></td></tr><tr style="height:17pt"><td style="width:139.5pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Tartrazine</span></p></td><td style="width:195.6pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt"><span style="font-size:10pt">See </span><a href="file:///y:\docs\html\tgo\tgo69_2.htm#note3%23note3" style="text-decoration:none"><span style="font-size:10pt; color:#000000">Note 3</span></a></p></td><td style="width:139.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>Tartrazine CI 19140</span></p></td><td style="width:123.8pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span>All</span></p></td><td style="width:99.1pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><span></span></p></td></tr><tr><td colspan="5" style="width:700.45pt; border:0.75pt solid #000000; vertical-align:top"><p style="margin-top:5pt; margin-bottom:5pt; font-size:10pt"><a id="note1"></a><span style="font-weight:bold">Note 1: Gluten</span><span> - it is recognised that formulations of medicines do not usually include gluten as a separate excipient, although it may be present naturally as</span><br><span>a constituent of some excipient ingredients, such as wheat starch. The Therapeutic Goods Administration agrees that medicines can be regarded as ‘gluten-free’</span><br><span>if the product contains no detectable gluten </span><span style="font-weight:bold">and</span><span> contains no oats or malt.</span><br><a id="note2"></a><span style="font-weight:bold">Note 2: Sugars</span><span> - </span><span style="font-weight:bold">Monosaccharides and disaccharides</span><span> - some sugar derivatives may not have a significant impact on glycaemic control.</span><br><a id="note3"></a><span style="font-weight:bold">Note 3: Tartrazine</span><span> - The Australian Guidelines for the Registration of Drugs Volume 2 permits tartrazine in products for ingestion if supplied before</span><br><span>15 February 1991. For products supplied after this date, tartrazine may only be used for topical products.</span></p></td></tr></tbody></table>