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Guidance on OTC Pediatric Acetaminophen Liquid Drugs


Federal Register Notice: FDA is making available a guidance for industry entitled Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen. It is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of non-prescription pediatric oral liquid acetaminophen drug products. It provides recommendations on acetaminophen concentration, container labels, carton labeling, and packaging of such products, as well as for any associated delivery devices. To download this guidance, click here. To view this notice, click here.