FDA Issues Guidance On Acetaminophen Usage

A guidance entitled “Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen” is being issued by FDA “to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription pediatric oral liquid acetaminophen drug products,” according to a Federal Register notice to be published Aug. 5. This guidance provides recommendations regarding acetaminophen concentration, container labels, carton labeling and packaging of such products, as well as for 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.