RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

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.

Read more:

Read all Breaking News from RegLink

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.