- The FDA has issued new draft guidance on specific labeling protocols for acetaminophen-containing products for children.
- The guidance provides labeling and formulation recommendations for children under 12 for OTC liquid acetaminophen-containing formulations.
- Despite the fact that some of the guidelines have already been the industry standard for some time, there are ongoing concerns about the potential for acetaminophen overdoses, which can lead to acute liver failure and death.
Acetaminophen is an important go-to anti-inflammatory for pain relief, fever reduction, and relief of muscle and/or joint pain; however, overdose can lead to liver injury and stomach bleeding. Guidance aimed at adult populations warns that overdosing may result in severe liver damage.
Decisions about pediatric dosing for acetaminophen are made by the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee.
Some specific examples of the new labeling guidance include: that all products intended for children should have a concentration of less than 160 mg per 5 mL; that the principal display panel contain information regarding age range for the product; the the graphic of the child on the panel reflect the age of the child for whom the product is intended; that dosing instructions be provided in milliliters; that an image of the drug delivery device be included on the panel display; and that all delivery devices be standardized and "appropriate."