Regulatory Focus™ > News Articles > TGA Proposes Warnings for OTC Oral Cough Medicines and Nasal Decongestants

TGA Proposes Warnings for OTC Oral Cough Medicines and Nasal Decongestants

Posted 31 March 2014 | By Louise Zornoza

Australia's Therapeutic Goods Administration (TGA) has released for comment proposed new warnings on the label of some OTC cough medicines intended for oral use by children.

The changes to the so-called Required Advisory Statements for Medicine Labels (RASML) follow recommendations made by TGA in 2012 to include warnings on products that contain the following ingredients: ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, pholcodine, or senega and ammonia.

The TGA has also proposed new warnings for over-the-counter (OTC) nasal decongestant medicines intended for topical use by children. The changes to the RASML would affect medicines that contain oxymetazoline or xylometazoline. The proposed new decongestant labeling would also address the issue of rebound congestion by requiring a new advisory statement to the effect that "Frequent or prolonged use may cause nasal congestion to recur or worsen."

The deadline for comments on both proposals is 25 April 2014.


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