Acetaminophen Panel To Mull Expanded Dosing, Standard Solid Concentration
This article was originally published in The Tan Sheet
FDA is asking a joint advisory panel to consider whether it should restrict firms to one standard acetaminophen concentration for all solid oral dosage single-ingredient pediatric products, among other measures to reduce dosing errors.
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Pediatric OTC acetaminophen product labels should include directions for children under 2 years and as young as 6 months and instructions for dosing by weight, a panel of advisors told FDA.
Over-the-counter drug firms will make single-ingredient liquid acetaminophen pediatric products only in one standard concentration to help prevent dosing errors, their trade association said May 4.
FDA's pediatric and nonprescription drugs advisory committees will consider whether the agency should add dosing information for children under 2 years to labels for OTC products containing acetaminophen at a joint meeting May 17-18.