The FDA has approved Kenvue's TYLENOL with Naproxen, the first and only over-the-counter fixed-dose combination of acetaminophen and naproxen sodium for pain relief. The product combines 650 mg of acetaminophen with 220 mg of naproxen sodium, offering fast-acting relief in under 30 minutes and up to 12 hours of relief in a single dose. The approval is supported by eight clinical studies showing superior pain relief compared to either ingredient alone, and the FDA has granted three years of exclusivity. Kenvue plans to make the product available soon at major U.S. retailers nationwide.
Kenvue Inc.FDA approval of first OTC fixed-dose combination TYLENOL with Naproxen, with three years of exclusivity.