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          AcetaminophenInformation by Drug Class Acetaminophen
  
  	
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    PrintAcetaminophen 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 pregnancyLimiting 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 OverdoseAcetaminophen 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 acetaminophenPediatric 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 ChildrenLabeling Changes for OTC Internal Analgesic, Antipyretic and Antirheumatic (IAAA)

Federal Register: Acetaminophen Final RuleResources 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

                                                                                  Content current as of:
      06/09/2022
              
              
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