CHPA Petitions For Acetaminophen Under-2 Dose Labeling
This article was originally published in The Tan Sheet
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.
You may also be interested in...
Committee report again includes item concerning FDA’s work on expanding access to opioid antagonist naloxone. It still doesn’t acknowledge agency’s interest in making drug available OTC in a nasal inhaler, but emphasizes access for pregnant and postpartum women.
Only 6% of children emptied medicine bottles with flow restrictors in 10 minutes, compared to 82% who emptied bottles with incompletely closed child-resistant caps within two minutes, a CDC study shows. But researchers and stakeholders suggest waiting for industry standards to implement flow restrictors.
The Consumer Healthcare Products Association, the Centers for Disease Control and Prevention and a public-private safe-medication initiative launch the “Up and Away and Out of Sight” campaign to educate caregivers about how to stop curious children from consuming drugs without supervision.