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)
