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U.S. Department of Health and Human Services


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Acephen (acetaminophen) rectal suppositories

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2010


Summary View



Liver Warning

This product contains acetaminophen. Severe liver damage may occur if your child inserts:

  • more than 5 suppositories in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen


(Updated in accordance with monograph Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use)