FDA Approval

FDA Approves First OTC Acetaminophen–Naproxen Combination for Up to 12 Hours of Pain Relief

Anthony Calabro, MA

Key Highlights

  • Acetaminophen/naproxen sodium is the first nonprescription fixed-dose tablet to combine the 2 analgesics.
  • The medication indicates for the temporary relief of minor aches and pains in adults and children aged 12 years or older.
  • The combination is dosed every 12 hours and may provide up to 12 hours of pain relief.

On July 24, the FDA approved Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg), the first nonprescription fixed-dose product to combine acetaminophen and naproxen sodium in a single tablet. The medication is indicated for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor pain of arthritis in adults and children aged 12 years or older.

The approval was supported by evidence establishing the effectiveness and safety of acetaminophen/naproxen sodium and demonstrating the contribution of each active ingredient to its overall pain-relieving effect. The FDA release did not identify a specific supporting study, describe a study design, or provide numerical efficacy or safety results.

According to the FDA, combining the 2 active ingredients in a single tablet provides consumers with “a new nonprescription option for up to 12 hours of pain relief.”

The release did not identify the most common adverse events associated with acetaminophen/naproxen sodium. However, the labeling warns patients not to use the medication with other acetaminophen-containing drugs because doing so may cause liver damage. It also includes NSAID-related warnings for stomach bleeding and increased risks of heart attack, heart failure, and stroke. These risks are higher when NSAIDs are used more than directed or for longer than directed.

Acetaminophen/naproxen sodium is dosed every 12 hours. The release did not specify the number of tablets per dose or the maximum treatment duration. Patients who are pregnant or breastfeeding should consult a healthcare professional before use. The Drug Facts label advises against using naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor.

Reference

  1. US Food and Drug Administration. FDA approves first nonprescription fixed-dose combination of acetaminophen and naproxen sodium for 12-hour pain relief. Published July 24, 2026. Accessed July 24, 2026.