Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
(2) Expression of quantity or proportion(2) Expression of quantity or proportion of active ingredients
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(2) Expression of quantity or proportion of active ingredients
Subject to paragraph 11(2)( i) and subsection 11(3) below, the quantity or proportion of an active ingredient to be included on a label must be expressed:
(a) for a discrete dosage unit - as the quantity of the active ingredient in the dosage unit;
(b) for a solid for ingestion, where there is no discrete dosage unit - as the quantity of the active ingredient contained in the stated weight of a suitable dose of the solid;
(c) subject to paragraph (d) below, if the medicine is a liquid for ingestion:
(i) as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid; or
(ii) in the case where the liquid for ingestion is one of a series of strengths containing the same active ingredient – as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid with the quantity or proportion of active ingredient expressed consistently across the series in terms of the same stated dose volume.
Example: Where the dose volume is 5 mL, and there are strengths of 1 mg/mL and 5 mg/mL, these must be labelled as 5 mg in 5 mL and 25 mg in 5 mL, respectively.
(d) for a medicine required to be prepared before use, and:
(i) where the process results in a medicine that is a liquid for ingestion:
(A) as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid after preparation in accordance with the instructions set out on the label of the medicine; or
(B) in the case where the medicine is one of a series of strengths containing the same active ingredient - as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid after preparation in accordance with the instructions set out on the label of the medicine with the quantity or proportion of active ingredient expressed consistently across the series in terms of the same stated dose volume; and
Example: Where the dose volume is 5 mL after preparation, and there are strengths of 1 mg/mL and 5 mg/mL, these must be labelled as 5 mg in 5 mL and 25 mg in 5 mL, respectively.
(ii) for any other medicines - as the weight or volume of active ingredient in a stated weight or volume of the medicine, after preparation in accordance with the instructions included in the label of the medicine;
(e) for a transdermal patch, as the total quantity of the active ingredient in each patch and the quantity of the active ingredient released in a stated time;
(f) for pressurised metered dose inhalers, dry powder inhalers and other metered dose products such as nasal sprays, the quantity of the active ingredient is: