Acetaminophen
Acetaminophen is an active ingredient in hundreds of over-the-counter (OTC) and prescription medicines. It relieves pain and fever. Acetaminophen can also be 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
- 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)
Resources For You
- Consumer Education: Using Acetaminophen and Nonsteroidal Anti-inflammatory Drugs Safely
- Don't Double Up on Acetaminophen
- Safe Use Initiative: Improving Acetaminophen Prescription Labels