OTC diphenhydramine may carry both antihistamine and antitussive claims.

Executive Summary

OTC DIPHENHYDRAMINE MAY BE INDICATED AS BOTH ANTITUSSIVE AND ANTIHISTAMINE in single-ingredient products and in cough/cold combination products under a proposed amendment to the OTC cold, cough, allergy, bronchodilator and anti-asthmatic combination products tentative final monograph published in the Feb. 23 Federal Register. The amendment also allows for the marketing of both diphenhydramine HCl and diphenhydramine citrate as antitussive ingredients in certain combination cough/cold products.