The FDA approved Tylenol with Naproxen as the first over-the-counter fixed-dose combination of acetaminophen and naproxen sodium.

The U.S. Food and Drug Administration has approved Tylenol with Naproxen, a new non-prescription pain reliever from Kenvue. This first-of-its-kind fixed-dose combination pairs 650 mg of acetaminophen with 220 mg of naproxen sodium, providing 12 hours of relief in under 30 minutes. The product is opioid-free and suitable for adults and children aged 12 and older to treat headaches, back pain, and arthritis. The administration announced that the approval aligns with a "great healthcare plan" to make safe pharmaceutical drugs more accessible. This milestone comes despite previous scrutiny from the administration, which suggested a potential link between acetaminophen use during pregnancy and childhood autism. Kenvue has maintained that decades of evidence support the safety of the brand. The FDA granted Kenvue three years of exclusivity for the new formulation. The product will soon be available at major U.S. retailers nationwide. Kenvue shares rose approximately 2% following the announcement, reflecting positive market sentiment for the flagship brand.

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