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.
Pain Medicine Use During Pregnancy
Limiting Acetaminophen’s Strength in Prescription Medicines
January, March, and April 2014; January 2011
FDA reminds health care professionals to stop dispensing prescription combination drug products with more than 325 mg of acetaminophen [ARCHIVED]
4/28/2014All manufacturers of prescription combination drug products with more than 325 mg of acetaminophen have discontinued marketing
3/26/2014FDA recommends health care professionals discontinue prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers [ARCHIVED]
1/14/2014FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure [ARCHIVED]
1/13/2011- FDA Consumer Update: New Steps Aimed at Cutting Risks from Acetaminophen
1/13/2011 Questions and Answers about Oral Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit [ARCHIVED]
1/13/2011- 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
Acetaminophen Associated with Rare Skin Reaction
August 2013
FDA Drug Safety Communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen - FDA Consumer Update: FDA Warns of Rare Acetaminophen Risk
At first signs of these rare but serious skin reactions, stop taking the product and seek medical attention right away. Questions and Answers: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen
Pediatric Medicines that Contain Acetaminophen
- Guidance for Industry: Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen (PDF - 82KB)
FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants [ARCHIVED]FDA Drug Safety Podcast for Consumers: Addition of another concentration of acetaminophen marketed for infants [ARCHIVED]- 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 May 17-18, 2011: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee Meeting Announcement
Advisory Committee Meeting – Liver injury related to the use of acetaminophen
Guidance for Industry
Labeling Changes for OTC Internal Analgesic, Antipyretic and Antirheumatic (IAAA)
April 29, 2009
Related Information
FDA Voice: FDA Reminds Consumers to Always Use Acetaminophen Safely - 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)