Kenvue's Tylenol with Naproxen Receives FDA Approval

The U.S. Food and Drug Administration approved a new over‑the‑counter tablet that pairs acetaminophen (Tylenol) with naproxen sodium. The product, marketed by Kenvue as Tylenol with Naproxen, was cleared on July 24 and is the first non‑prescription medication to combine these two widely used pain relievers in a single dose.

Each tablet contains 325 mg of acetaminophen and 110 mg of naproxen sodium; the recommended dosing is two tablets every 12 hours, delivering 650 mg of acetaminophen and 220 mg of naproxen per dose. The drug is indicated for temporary relief of minor aches and pains such as headache, backache, muscular aches, toothache, menstrual cramps, and mild arthritis in adults and children 12 years and older.

Kenvue says the combination begins working in under 30 minutes and lasts up to 12 hours, citing eight clinical studies in which the product outperformed each ingredient taken alone, although the data have not yet been peer‑reviewed. The FDA granted Kenvue a three‑year exclusivity period for the formulation. The agency noted that while both ingredients have well‑characterized safety profiles, acetaminophen carries a risk of liver injury if overdosed.

The approval aligns with a broader push to expand OTC drug availability, offering a non‑opioid option for persistent pain without prescription requirements.