DIPHENHYDRAMINE ANTITUSSIVE/ANTIHISTAMINE MONOGRAPH DIRECTIONS FOR USE
This article was originally published in The Tan Sheet
Executive Summary
DIPHENHYDRAMINE ANTITUSSIVE/ANTIHISTAMINE MONOGRAPH DIRECTIONS FOR USE are among the issues that "need to be resolved before diphenhydramine can be used to perform both functions (antitussive and antihistamine)," FDA said in a notice published in the June 3 Federal Register. The agency is concerned, specifically, with the "amount of drug to be taken and time interval for taking the drug." The notice, a final rule amending the final monograph for OTC antitussives, allows the use of diphenhydramine citrate and diphenhydramine hydrochloride in single-ingredient antitussive products only.