Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of the Tentative Final Monograph for Combination Drug Products

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The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph for over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic combination drug products to classify combination drug products containing the ingredients diphenhydramine citrate or diphenhydramine hydrochloride. The agency recently amended the final monograph for OTC antitussive drug products (products used to relieve cough) to include the ingredients diphenhydramine citrate and diphenhydramine hydrochloride. The agency also previously included diphenhydramine citrate and diphenhydramine hydrochloride in the final monograph for OTC antihistamine drug products. This proposal is part of the ongoing review of OTC drug products conducted by FDA.