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Regulatory Focus™ > News Articles > Australia: TGA Restricts OTC Cough and Cold Medications

Australia: TGA Restricts OTC Cough and Cold Medications

Posted 20 August 2012 | By Ansis Helmanis

Australia's Therapeutic Goods Administration (TGA) has concluded that over-the-counter (OTC) cough and cold medicines registered with the agency should not be given to children under the age of six, and should be given only on the advice of health professionals for those ages six to 12.

The restrictions stem from a review of the safety and efficacy of these products conducted by the agency that found although there are no immediate safety risks associated with the products, there are potential risks for children with only limited evidence of benefits. 

Products placed on the market prior to 1 September 2012, will be allowed to remain on the market, but products marketed after that date must include the revised labeling.


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