Does FDA permit the marketing and sale of an OTC Cough / Cold Drug Product containing a combination of the 3 following active ingredients: Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride and Pectin?
Food and drug regulatory attorney Karl M. Nobert answered: Yes. A Cough / Cold OTC Drug containing such a combination can be legally marketed and sold in the U.S. without risk of FDA enforcement action, so long as it is done in compliance with FDA’s OTC drug regulations a …
