Potential Pediatric Acetaminophen Label Changes Resurface In Tylenol Class Action Settlement
Settlement could be another milestone in the contentious history of labeling for OTC acetaminophen single-ingredient products generally, and for infant’s and children’s products specifically. Plaintiffs alleged they were misled by J&J to pay more for Infant's Tylenol even though its formulation is the same as Children's Tylenol.
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Appropriators are "concerned that the lack of dosing information" on OTC drugs for children ages six months to 2 years "may lead to dosing errors, adverse events and inadequate treatment of fever and pain.” They also ask USDA about fraud in its National Organic Program.
Johnson & Johnson narrows its pediatric Tylenol tablets a single 160 mg dose and other manufacturers are expected to follow suit, in line with a US FDA panel recommendation.
Pediatric OTC and Rx dosage errors reach 43% for parents using a dosing cup but 16.7% with a 0.2 mL oral syringe, according to researchers who say recommending oral syringes over cups, particularly for small doses, should be part of a comprehensive pediatric labeling and dosing strategy.