GlaxoSmithKline Australia - 'Paracetamol only' or 'Paracetamol and codeine only' products

Published in the Commonwealth of Australia Gazette No. GN 49, 8 December 2004

THERAPEUTIC GOODS ACT 1989

I, PIO CESARIN, Director, Non-Prescription Medicines Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing for the purposes of Section 42DF(1) of the Therapeutic Goods Act 1989, give notice that the restricted representation described in paragraph (a) below, has been approved for use in advertisements directed to consumers, for the products listed in paragraph (b), provided the conditions identified in paragraph (c) are met:

1. Representations to the effect that advertisements to consumers for the goods described in paragraph (b) may refer to:
   "suitable for pain and fever relief for asthmatics who are sensitive to aspirin and non-steroidal anti-inflammatory drugs (NSAIDs)";
2. 'Paracetamol only' or 'paracetamol and codeine only' products
   sponsored by GlaxoSmithKline Australia Pty Ltd (Consumer Healthcare Division); and
3. the following statement is to appear in all advertisements for the products listed in paragraph (b) where the representation described in paragraph (a) is used -
   "Around 20% of asthmatics are sensitive to aspirin or NSAIDs. Less than 2% of asthmatics are sensitive to paracetamol and reactions tend to be less severe and of shorter duration".

Dated this 26th day of November 2004

PIO CESARIN
Delegate for the Secretary to the Department of Health and Ageing