Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen. Guidance for Industry.

摘要

This guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription also known as over-the-counter or OTC-pediatric oral liquid acetaminophen drug products. Many of these products are marketed under the OTC conditions stated in FDA’s Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human Use (the IAAA TFM).