The FDA has approved Tylenol with Naproxen as an over-the-counter, fixed-dose combination drug indicated for the temporary relief of minor aches and pains. The drug combines 650 mg of acetaminophen (Tylenol, Kenvue Brands) with 220 mg of naproxen sodium (Aleve, Bayer HealthCare), an NSAID. It has been approved for adults and children 12 years and older for headache, backache, muscular aches,

First OTC fixed-dose combination product to pair acetaminophen with naproxen sodium

FDA Approves TYLENOL® with Naproxen, the First and Only Over-the-Counter Fixed-Dose Combination of Acetaminophen (650 mg) and Naproxen Sodium (220 mg)