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.
Our Position
Acetaminophen is a safe OTC analgesic staple that's widely used by adults and children when following recommended dosage guidelines. Lawmakers should oppose restrictions to access for either age group, as drug regulatory entities already actively monitor research and update consumer protections accordingly to allow availability alongside continued evidence-based education. Excessive limits would deprive the public of an efficacious, affordable longtime remedy.
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 comments on the proposed rule, which proposes new warning and other labeling requirements for internal analgesic, antipyretic, and antirheumatic OTC drug products.
CHPA appreciates the opportunity to provide comments to the FDA in response to the draft guidance for industry “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions”.
FDA Announcement of a proposed safety-based Administrative Order that proposes to add a skin allergy warning to labeling requirements for acetaminophen-containing drug products.
FDA Announcement of a proposed safety-based Administrative Order (AO) to address dosage strengths of oral, single ingredient, pediatric acetaminophen products. This AO proposal includes the addition of weight and age-based dosing for children under age 12.
Understand how CHPA’s member companies are working to replenish supply quickly by directing products where they are needed most. This document also includes information about where parents can find these medicines and additional self-care options to aid in comfort and relief.
