FDA approves Tylenol® with Naproxen, the first and only over-the-counter fixed-dose combination of acetaminophen (650 mg) and naproxen sodium (220 mg)

The FDA has granted approval for Tylenol with Naproxen, marking the first over-the-counter fixed-dose combination of acetaminophen and naproxen sodium. This product contains 650 mg of acetaminophen and 220 mg of naproxen sodium in a single dose. It is designed to provide relief that starts in under 30 minutes and lasts for 12 hours.

This development addresses a gap in non-opioid pain management. Market research from Kenvue indicates that 75 percent of individuals suffering from persistent pain are dissatisfied with their existing options. By combining these two established ingredients, the new formulation removes the need for patients to manage staggered dosing schedules or combine multiple products independently.

The approval follows eight clinical studies that showed the fixed-dose combination outperformed acetaminophen and naproxen sodium when taken individually. This new product is expected to provide an alternative for those seeking effective, non-prescription pain relief without the risks associated with opioids.

Tylenol with Naproxen will be available at major U.S. retailers soon. The FDA has awarded a three-year exclusivity period to Kenvue for this formulation. Consumers are advised to follow the Drug Facts label and consult with healthcare professionals to determine if this product fits their specific needs.