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


FDA cough/cold monograph correction

This article was originally published in The Tan Sheet

Executive Summary

Directions on menthol 5 mg or 10 mg single-ingredient or combination drugs for cough suppressant/oral anesthetic or antitussive/oral anesthetic uses should state "dissolve lozenge slowly in the mouth. Repeat every two hours as needed or as directed by a doctor" instead of "repeat every hour as needed," as stated in the OTC Drug Cough, Cold, Allergy, Bronchodilator & Antiasthmatic Combination Drug Products Final Monograph. FDA is slated to publish the correction to the final rule in the April 14 Federal Register. Final monograph was published in December 2002 (1"The Tan Sheet" Dec. 23, 2002, p. 3)...

You may also be interested in...

Cough/Cold Combination Final Monograph Includes Four-Ingredient Combos

FDA has designated combinations of analgesic-antipyretic, expectorant and nasal decongestant ingredients, as well as analgesic-antipyretic, antitussive, expectorant and nasal decongestant combinations, as Category I in the final monograph on cough/cold combinations

US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail

Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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