Federal regulators have approved a new combination medication that merges acetaminophen and naproxen sodium into a single tablet for pain relief.

The U.S. Food and Drug Administration (FDA) has approved Tylenol with Naproxen, a new over-the-counter medication combining acetaminophen and naproxen sodium. Manufactured by Kenvue, the drug is designed to provide fast-acting relief from acetaminophen and long-lasting effectiveness from naproxen sodium. It is intended for the temporary relief of minor aches and pains, including headaches, backaches, and arthritis pain, in adults and children 12 years and older.

Dosage and Clinical Findings

Each tablet contains 325 mg of acetaminophen and 110 mg of naproxen sodium, with a recommended dosage of two tablets every 12 hours. Kenvue states the medication begins working within 30 minutes and provides relief for up to 12 hours. The company reported that eight clinical studies demonstrated superior pain relief compared to using either ingredient alone, with findings scheduled for presentation at the PainWeek 2026 conference in September.

Safety and Expert Perspectives

While the medication offers a non-opioid alternative, medical experts emphasize the importance of following safety guidelines. Acetaminophen carries risks of liver damage in high doses, while naproxen can cause stomach bleeding or allergic reactions. Dr. Sean Mackey of Stanford University noted that the product is a convenient repackaging of established drugs rather than a groundbreaking medical advance. Dr. Vernon Williams of Cedars-Sinai cautioned that consumers must still adhere to safety precautions to avoid over-medication or dangerous interactions with other drugs.