Citizen Petition Requesting an Enforcement Policy Permitting Manufacturers of Single-Ingredient Acetaminophen OTC Drugs to Include Labeling Instructions for Children

CHPA requests that FDA publish a statement of enforcement policy expressly permitting manufacturers of single-ingredient acetaminophen OTC drugs subject to the ongoing internal analgesic, antipyretic, and antirheumatic monograph proceedings to including labeling on products that provide instructions for use in children aged six months to two years.