
FDA Releases Guidance on OTC Pediatric Drug Products
FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.
FDA has released
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.
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