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

• FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy

Limiting Acetaminophen's Strength in Prescription Medicines

• All manufacturers of prescription combination drug products with more than 325 mg of acetaminophen have discontinued marketing
• 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
• Federal Register Notice: Prescription Drug Products Containing Acetaminophen; Actions to Reduce Liver Injury From Unintentional Overdose

Acetaminophen Associated with Rare Skin Reaction

• FDA Drug Safety Communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen
• 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
• FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants
• FDA Consumer Update: Know Concentration Before Giving Acetaminophen to Infants
• 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

Labeling Changes for OTC Internal Analgesic, Antipyretic and Antirheumatic (IAAA)

• Federal Register: Acetaminophen Final Rule

Related Information

• FDA Voice: FDA Reminds Consumers to Always Use Acetaminophen Safely
• Safe Use Initiative: Improving Acetaminophen Prescription Labels

Resources For You

• Questions and Answers: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen
• Consumer Education: Using Acetaminophen and Nonsteroidal Anti-inflammatory Drugs Safely
• Sometimes Drugs and the Liver Don't Mix
• A Guide to Safe Use of Pain Medicine