Drugs
Acetaminophen Information
Acetaminophen is an active ingredient in hundreds of over-the-counter (OTC) and prescription medicines. It relieves pain and fever. And, it is also combined with other active ingredients in medicines that treat allergy, cough, colds, flu, and sleeplessness. In prescription medicines, acetaminophen is found with other active ingredients to treat moderate to severe pain. Acetaminophen can cause serious liver damage if more than directed is used. The FDA has taken action to improve the safety of consumers when using acetaminophen.
Changes in Infant's Liquid OTC Medicines
December 2011
FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants FDA Drug Safety Podcast for Consumers: Addition of another concentration of acetaminophen marketed for infants - FDA Consumer Update: Know Concentration Before Giving Acetaminophen to Infants
Overdosing can be fatal. - Questions and Answers – Important change in concentration for over-the-counter (OTC) liquid acetaminophen marketed for infants
- FDA Voice: Acetaminophen – It’s Important to Give the Correct Dose to our Children
Limiting Acetaminophen’s Strength in Prescription Medicines
January 2011
FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure - FDA Consumer Update: New Steps Aimed at Cutting Risks from Acetaminophen
Measures cover prescription products. - Questions and Answers: Oral Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit
- FDA Press Release: FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings
- Federal Register Notice: Prescription Drug Products Containing Acetaminophen; Actions to Reduce Liver Injury From Unintentional Overdose
Prescription Drug Products Containing Acetaminophen; Actions to Reduce Liver Injury From Unintentional Overdose - Docket Number FDA-2011-N-0021-0001 List of Marketed Acetaminophen-Containing Prescription Products List of Affected Prescription Acetaminophen Manufacturers
Advisory Committee Meeting – Pediatric dosing
May 2011
- Meeting Announcement and background materials: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee
- Summary Minutes: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee (PDF - 49KB)
- Transcript: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee (PDF - 728KB)
Advisory Committee Meeting – Liver injury related to the use of acetaminophen
June 2009
- Meeting announcement and background materials: Joint Meeting of the Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee
- Summary minutes: Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee (PDF - 132KB)
- Transcript: Joint Meeting Of The Drug Safety And Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee And The Anesthetic And Life Support Drugs Advisory Committee Meeting To Address The Public Health Problem Of Liver Injury Related To The Use Of Acetaminophen In Both Over-The-Counter And Prescription Products (PDF - 926KB)
Labeling Changes for OTC Internal Analgesic, Antipyretic and Antirheumatic (IAAA)
April 29, 2009
Related Information
Notice to Industry: Draft Guidance for Over-the-Counter Products that Contain Acetaminophen - Safe Use Initiative: Improving Acetaminophen Prescription Labels
- Science Background (2004): Safety Concerns Associated with Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for Internal Use (PDF - 20KB)
- Widgets for Consumers and Professionals