The U.S. Food and Drug Administration (FDA) has approved Tylenol with Naproxen, the first nonprescription fixed-dose combination of acetaminophen and naproxen sodium for up to 12 hours of pain relief. The approval introduces a new over-the-counter (OTC) option for consumers seeking long-lasting, dual-action pain management without a prescription.
The newly approved medicine contains 325 mg of acetaminophen and 110 mg of naproxen sodium per tablet. The recommended adult dose is two tablets every 12 hours, delivering 650 mg of acetaminophen and 220 mg of naproxen sodium in each dose. It is approved 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.
According to the FDA, while several OTC medicines combine acetaminophen with other nonsteroidal anti-inflammatory drugs (NSAIDs), this is the first product to combine acetaminophen with naproxen sodium in a single nonprescription tablet. The approval was supported by evidence demonstrating the safety and effectiveness of the combination and the contribution of each ingredient to pain relief.
The product is manufactured by Kenvue Brands LLC, the company behind the Tylenol brand. Kenvue states that the dual-action formulation begins working in under 30 minutes and provides pain relief for up to 12 hours, potentially reducing the need for multiple doses throughout the day.
The FDA emphasized that consumers should carefully follow the product labeling. Because the medicine contains acetaminophen, it should not be used with other acetaminophen-containing products due to the risk of liver damage. As it also contains an NSAID, the label includes warnings regarding stomach bleeding, as well as an increased risk of heart attack, heart failure, and stroke, particularly when used at higher doses or for longer than recommended. Pregnant or breastfeeding individuals are advised to consult a healthcare professional before use, and naproxen sodium should generally be avoided after 20 weeks of pregnancy unless directed by a physician.
The approval expands the range of available nonprescription pain relief options and offers consumers a convenient fixed-dose combination that targets pain through two different mechanisms of action in a single tablet.
