The US Food and Drug Administration (FDA) has issued draft guidance, Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen,
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.
Generally, these products are marketed under the OTC Drug Review (FDA’s Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (the IAAA TFM). The FDA plans to address portions of the tentative final monograph through the notice and comment rulemaking process. In the meantime, however, to encourage safer use of these products, we are providing recommendations for acetaminophen concentration, container labels and carton labeling, and packaging of such products and providing 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. Unless specified, these recommendations apply to both single ingredient and combination ingredient OTC liquid oral drug products (such as suspensions, solutions, elixirs, and syrups) that are labeled for use by children under 12 years of age and contain acetaminophen.