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

Guidance On Acetaminophen Allergy Warning Trails Industry's Change

Executive Summary

Final US guidance adds CHPA's suggestion for an example for a warning on labeling for products containing both acetaminophen and aspirin, needed to highlight where “Allergy Alert” and “Liver Warning” statements are on those products' labels.

You may also be interested in...



Rulemaking Needed For Acetaminophen Skin-Reaction Label Warning – CHPA

The Consumer Healthcare Products Association encourages FDA to conduct a rulemaking to require label changes for acetaminophen OTCs the agency is suggesting in a draft guidance. The trade group also asks for clarity in the order warnings are placed on product labels.

In Brief: Acetaminophen Warnings, OTC HSA Bill, Durbin’s Supplement Reg Bill

FDA adds acetaminophen warnings; CHPA suggests 4-aminophenol standard; OTC HSA bill in House; supplement registration bill reintroduced; FSMA user fees still on hold; more scrutiny of energy drinks; and Public Citizen pans OTC Oxytrol.

Unprecedented To Lawful: Regulatory Precedent Needed For Cannabinoids’ Use In Supplements?

“This is truly uncharted territory because we’ve never had this situation,” says CHPA senior VP David Spangler. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”

Topics

UsernamePublicRestriction

Register

PS078529

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

Cancel