FDA approves first OTC acetaminophen-naproxen combo pill

The U.S. Food and Drug Administration (FDA) on July 24 approved Tylenol with Naproxen, the first over-the-counter, fixed-dose combination of acetaminophen and naproxen sodium, reported OSHA Review. Each dose delivers 650 mg of acetaminophen and 220 mg of naproxen sodium, providing up to 12 hours of relief.

The product is indicated for adults and children 12 and older for minor pain, including toothache, headache, and muscular aches, according to the FDA. Kenvue, the manufacturer, said the tablet is opioid-free and expected to reach major U.S. retailers soon.

For dental practices, the approval adds a new evidence-based, nonprescription option to recommend for managing acute or post-procedure pain without opioids, per OSHA Review.

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