Acetaminophen is the most common drug ingredient in the United States. It’s found in more than 600 different medicines, including prescription and over-the-counter (OTC) pain relievers, fever reducers, and sleep aids as well as cough, cold, and allergy medicines. Each week, approximately 23 percent of U.S. adults — or 52 million consumers — use an acetaminophen-containing medicine.
Safe use of acetaminophen is a top priority for manufacturers of OTC medicines. Manufacturers work closely with FDA, healthcare provider groups, pharmacist groups, and consumer health advocates to drive safe and responsible use of acetaminophen.
Briefing book for the Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee, June 29-30, 2009.
CHPA appreciates the opportunity to provide comments to the FDA in response to the draft guidance for industry “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions”.