Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen; Draft Guidance for Industry; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Over-the- Counter Pediatric Liquid Drug Products Containing Acetaminophen." The draft guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of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 (OTC), acetaminophen-containing pediatric liquid drug products. This guidance provides recommendations for acetaminophen concentration, container labels and carton labeling, packaging of such products, and recommendations regarding any associated delivery devices. FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion.