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WASHINGTON — The Consumer Healthcare Products Association on Monday asked the Food and Drug Administration to take action to ensure that the millions of caretakers who use acetaminophen products in young children have access to convenient and accurate dosing information. Representing makers of over-the-counter single-ingredient liquid acetaminophen medicines for children, CHPA submitted a citizen petition requesting that the FDA publish a “statement of enforcement policy” permitting manufacturers of OTC single-ingredient liquid pediatric acetaminophen products to include dosing information for children ages 6 months to 2 years on the Drug Facts label of these medicines.
While acetaminophen is approved for use in young children, the currently allowed labeling under tentative final monograph includes only “ask a doctor” in the dosing directions for children ages 6 months to 2 years.
“The peak of acetaminophen usage in children is for those ages 6 months to 23 months, yet the labeling of these products lacks instructions for this population,” stated Barbara Kochanowski, CHPA VP of regulatory and scientific affairs. “Young children can spike a fever at any time of the day or night, and to get dosing information for children under 2, caretakers must proactively seek out information from a healthcare provider rather than having the convenience of instructions printed on the Drug Facts label," she said. “Providing clear, consistent instructions directly on the label will help ensure that caretakers appropriately dose children under 2 years of age, potentially reducing the likelihood of dosing errors and dosing ‘guesses’ in the middle of the night.”
In its citizen petition, CHPA requested permission for manufacturers to include pediatric dosing for children ages 6 months to 2 years on product labels moving forward, while rulemaking around the monograph is finalized. CHPA recommended a single, standardized age and weight-based chart — based on the researched and established dosing recommendations of multiple pediatric and primary care medical association treatment guidelines — which all manufacturers could adopt.
In May 2011, a joint FDA Pediatric Advisory Committee and Nonprescription Drugs Advisory Committee unanimously recommended that OTC single-ingredient liquid pediatric acetaminophen products include dosing information for children ages 6 months to 2 years.
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