PROMETHAZINE OTC COUGH/COLD COMBOs CANNOT CONTAIN ADDITIONAL ANTIHISTAMINES

Executive Summary

Promethazine OTC cough/cold combination products may not contain additional antihistamine ingredients, FDA said in a Nov. 14 Federal Register notice clarifying its intent in the proposed rule for cough-cold combinations. The TFM, published on Aug. 12, could be interpreted "to mean that promethazine hydrochloride and another antihistamine ingredient ... could be combined with other nonantihistamine active ingredients." The intended meaning of the proposed rule, FDA said, is "that only promethazine hydrochloride, without any other antihistamine active ingredients, may be combined with other nonantihistamine active ingredients" identified in the TFM.