Retailers advised of new labelling of cough and cold medicines

02 July 2012

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The Australian Self-Medication Industry (ASMI), the industry body representing evidence-based, non-prescription consumer healthcare products, today advised that new labelling for cough and cold medicines would soon begin to appear in pharmacies and other retail outlets.

The change comes as a result of a 2009 review by the Therapeutic Goods Administration (TGA) into children's cough and cold medicines.

The TGA's review examined children's products containing antihistamines, antitussives, mucolytics, expectorants and decongestants used in many over-the-counter (OTC) preparations.

As a result of this review, the TGA now requires cough and cold products containing one or more of these substances to transition their labelling to indicate that:

  • The products are not to be used for children under 6 years of age.
  • For children between 6 and 12 years of age, the advice of a pharmacist or doctor should initially be sought before giving the products.

ASMI Regulatory and Scientific Affairs Director, Mr Steve Scarff said the TGA's action was based on an assessment of the risks and benefits associated with these products. "In the absence of modern efficacy data, the TGA took a precautionary approach and decided to limit the age groups for which there would be labelled dosing instructions," he said.

Over coming months, retailers will see cough and cold products transitioning their labelling in accordance with the TGA decision. There is no action that retailers are required to take. There is no requirement to return existing stock and retailers are permitted to continue selling stock with the previous dosage instructions without any time restriction.

There will be no change to the scheduling of affected medicines.
Consumers may notice different dosing instructions when they purchase cough and cold products for their children.

The new labels no longer contain instructions for children under 6 years of age and may now carry instructions to only use the product for children between 6 and 12 on the advice of a doctor or pharmacist.

"It is worth remembering that there has been no change in the products themselves, no change to where consumers can buy them and no change to the adult dosing.

As with all other medicines, it is important to take note of the label warnings and only use the products as directed. Consumers should read labels carefully, strictly follow all the directions and, if symptoms persist, consult a doctor or pharmacist.

Further information
Further information regarding the TGA's review of children's cough and cold medicines can be found on the following pages of the TGA website:
About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. ASMI's mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy.

Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 298