Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS014660

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel