FDA approves first OTC acetaminophen/naproxen combo for 12-hour pain relief

FDA has approved Tylenol with Naproxen, the first nonprescription fixed-dose combination of acetaminophen and naproxen sodium, providing clinicians with a new option to recommend for temporary relief of common pain conditions.

The new product combines acetaminophen 325 mg with naproxen sodium 110 mg in a single tablet dosed every 12 hours. It is indicated for the temporary relief of headache, backache, muscular aches, toothache, menstrual cramps, minor arthritis pain, and other minor aches and pains in adults and children aged 12 years and older. While acetaminophen is available in combination with other NSAIDs, this is the first OTC product to pair it with naproxen sodium.

This option may simplify recommendations for patients who already use both acetaminophen and an NSAID for short-term pain relief. A single combination product may reduce the need to alternate or coordinate separate medications while taking advantage of the complementary analgesic mechanisms of acetaminophen and naproxen.

Approval was supported by studies demonstrating the effectiveness and safety of the fixed-dose combination, including evidence that each ingredient contributed to the overall analgesic effect. The product's labeling is consistent with existing OTC acetaminophen- and NSAID-containing products.

Counseling remains important because the combination carries the established risks of both drug classes. Patients should be reminded not to take additional acetaminophen-containing products because of the risk for liver injury. As with other NSAIDs, labeling warns about gastrointestinal bleeding and increased risks for MI, heart failure, and stroke, particularly with higher-than-recommended doses or prolonged use. The label also advises against using naproxen at 20 weeks of pregnancy or later unless specifically directed by a clinician.

Source: FDA. (2026 Jul 24). FDA approves first nonprescription fixed-dose combination of acetaminophen and naproxen sodium for 12-hour pain relief