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ACETAMINOPHEN PEDIATRIC PACKAGING LIMITATION AT 2,400 MG

Executive Summary

ACETAMINOPHEN PEDIATRIC PACKAGING LIMITATION AT 2,400 MG per container is suggested by the American Academy of Pediatrics in an August 14 letter to FDA. The academy is urging FDA to restrict the number of 80 mg dosage units per container of pediatric acetaminophen to 30 dosages. "In other words," AAP President Donald Schiff, MD, said, "a container should not contain more than 2,400 mg total of acetaminophen either in solid dosage form or liquid dosage form." The AAP wrote to FDA to clarify an earlier recommendation by the group's Committee on Drugs. The Committee had suggested that the quantity of pediatric dosage units per container be limited to the number "currently marketed." In mid-June, FDA requested further specifics, noting that while the majority of manufacturers already voluntarily limit the number of dosage units per container to 30, some manufacturers exceed this limit. FDA pointed out that "there are a number of products currently marketed that contain 100 pediatric dosage units." The FDA also asked AAP to spell out its rationale for recommending the continuation of the existing 36-tablet limit for pediatric dosage forms of aspirin. In response, AAP stated that "the existing limitation has significantly reduced the potential for toxic exposure to small children who gain access to a container of children's aspirin." In addition, AAP reiterated its earlier recommendation that blister packaging of individual dosage units of both aspirin and acetaminophen products be excluded from the dosage limitations. "Blister packaging has been shown to significantly inhibit access to a potentially toxic dose of the medication even if a toddler gains access to the package," AAP's Shiff stated.
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