Label Changes for:

Acephen (acetaminophen) rectal suppositories

April 2010

Changes have been made to the WARNINGS sections of the safety label.

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

WARNINGS

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)

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