FDA Releases Guidance on OTC Pediatric Drug Products

FDA has released draft guidance that outlines ways manufacturers, packagers, and labelers can minimize the risk of liver damage to pediatric consumers that use over-the-counter (OTC) acetaminophen-containing pediatric liquid drug products. The draft guidance highlights FDA’s recommendations for acetaminophen concentration, container labels and carton labeling, and packaging. It also provides recommendations regarding any associated delivery devices.

According to the guidance, FDA recommendations have been made to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion. The recommendations apply to both single ingredient and combination ingredient OTC liquid oral drug products (i.e., suspensions, solutions, elixirs, and syrups) that are labeled for use by children under 12 years of age and contain acetaminophen.