Final rule bans certain OTC cough-cold combination drugs


WASHINGTON (Reuters Health) – The US Food and Drug Administration (FDA) issued on Wednesday a final rule banning over-the-counter combination oral drug products that pair a bronchodilator with an analgesic, analgesic-antipyretic, anticholinergic, antihistamine, antitussive or stimulant active ingredient.

The agency said that it knows of no currently-marketed OTC drugs that meet that description.

Oral bronchodilator active ingredients include ephedrine and related substances. The FDA has in the past voiced strong concerns about weight-loss dietary supplements that combine ephedrine/ephedra with stimulants like caffeine. The new rule–while applying only to cough, cold and allergy drugs–serves to fortify the agency's position that such ingredient combinations may be unsafe.

The final rule will take effect 30 days after its scheduled publication in Thursday's Federal Register. It is part of the FDA's ongoing review of OTC products.

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