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Diphenhydramine combinations with other antihistamines/antitussives are Category III -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

DIPHENHYDRAMINE COMBOS WITH ANTIHISTAMINES/ANTITUSSIVES ARE CATEGORY III, according to an amendment to the OTC cough/cold combination products tentative final monograph published in the Feb. 23 Federal Register. FDA's proposal to place diphenhydramine/antihistamine and diphenhydramine/antitussive combos in Category III (data insufficient to permit classification) marks a change from the OTC panel's Category II (not safe and effective) recommendation. Combination products in this category include diphenhydramine (HCl and citrate) with dextromethorphan and diphenhydramine with chlorpheniramine.





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