FDA Clarifies Label Warning For Acetaminophen Liver Damage
This article was originally published in The Tan Sheet
Executive Summary
The agency seeks to clarify potential confusion for consumers linked to label statements about the level of acetaminophen that can pose a threat. FDA proposes an alternative warning to be used on labels of some acetaminophen-containing products.
You may also be interested in...
Exclusivity Awaits OTC Ibuprofen-Acetaminophen Combination As Safety Concerns Trail Ingredients
GSK will market Advil Dual Action with Acetaminophen noting potential risks for both of the product’s active ingredients with labeling highlights FDA requires. It can counter labeling about risks by noting studies show the combination has better efficacy than larger doses of each drug used separately.
In First For US OTC Market, Advil Line Extension Combines Ibuprofen And Acetaminophen
CDER approval of Pfizer's NDA introduces a new formulation to the US OTC market. Labeling for was approved with the requirement of adding bullet points for an “Acetaminophen liver damage warning” and an “NSAID stomach bleeding warning” on all immediate containers.
McNeil Lowers Recommended Maximum Dose For Extra Strength Tylenol
McNeil Consumer Healthcare lowers the maximum daily dose indicated on labels of Extra Strength Tylenol, the first in a series of dosing changes for the firm’s acetaminophen-containing products.