CHPA Petitions For Acetaminophen Under-2 Dose Labeling

CHPA urges FDA not to wait until it publishes the final internal analgesics, antipyretic and anti-rheumatic monograph before allowing manufacturers to label acetaminophen products with dosing information for children 6 months to 2 years old. In a citizen petition, the trade group proposes FDA publish a statement of enforcement policy expressly permitting the use of a standardized age- and weigh-based dosing chart.

The Consumer Healthcare Products Association petitions FDA to allow labels for single-ingredient acetaminophen OTC monograph products to include a standard dosing chart for children aged 6 months to 2 years to reduce the risk of dosing errors.

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