Kenvue's Tylenol with Naproxen Receives FDA Approval for OTC Pain Relief

The U.S. Food and Drug Administration has approved Kenvue Brands’ new over‑the‑counter product Tylenol with Naproxen, the first fixed‑dose combination of acetaminophen (650 mg) and naproxen sodium (220 mg). The drug is designed to provide fast‑acting pain relief in under 30 minutes and up to 12 hours of duration, offering an alternative to prescription opioids and separate acetaminophen or NSAID products.

Kenvue cited eight clinical studies showing the combination delivers better pain relief than either ingredient alone, and a consumer survey indicating significant dissatisfaction with existing options. The agency granted a three‑year exclusivity period, and the product is expected to reach major U.S. retailers soon. Health experts caution consumers to review all medication labels, as the Tylenol brand name may lead to accidental duplication of acetaminophen or NSAIDs, increasing risks of liver injury or gastrointestinal bleeding.