The FDA approved a combination tablet of 325-mg acetaminophen and 110-mg naproxen sodium (Tylenol with Naproxen) for over-the-counter (OTC) pain relief, the agency announced Friday.
The opioid-free combination tablet is indicated for the temporary relief of minor aches and pains from headaches, backaches, muscular aches, toothaches, menstrual cramps, and minor arthritis pain in adults and children ages 12 and older.
The treatment begins working in under 30 minutes and provides 12 hours of pain relief in a single dose. It is backed by eight clinical studies that showed superior pain relief compared with acetaminophen or naproxen sodium (Aleve 220 mg), said drugmaker Kenvue.
“Across the eight clinical studies supporting the FDA approval, the 650-mg acetaminophen and 220-mg naproxen sodium fixed-dose combination consistently outperformed either ingredient alone,” principal investigator Todd Bertoch, MD, of CenExel Clinical Research, said in a news release.
“What makes this meaningful for clinicians is not just the efficacy; it’s the rigor of the development program and the fact that patients can now access a clinically proven fixed-dose combination over-the-counter,” Bertoch added.
Other combination acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) products are available, but this is the first product to combine naproxen sodium with acetaminophen, the FDA said.
The labeling for the acetaminophen-naproxen combination is consistent with other nonprescription products in its class and includes standard warnings that apply to both acetaminophen- and NSAID-containing products, the agency noted.
“As with all acetaminophen-containing products, consumers are warned not to use Tylenol with Naproxen with other drugs containing acetaminophen, as doing so may cause liver damage,” the FDA said. “As with all NSAID-containing products, the labeling includes warnings for stomach bleeding and for increased risk of heart attack, heart failure, and stroke — risks that are higher when NSAIDs are used more than directed or for longer than directed.”
The labeling also includes pregnancy-related recommendations consistent with other nonprescription products that contain acetaminophen or NSAIDs, advising that women who are pregnant or breastfeeding ask a health professional before use. The drug facts label indicates it is important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, the FDA said.
Acetaminophen has been under scrutiny since the Trump administration raised concerns about an unproven link between prenatal acetaminophen use and autism, which major medical organizations and large population studies in multiple countries have contradicted.
The acetaminophen-naproxen combination tablets will be available soon at major U.S. retailers, Kenvue said. The FDA granted the company a 3-year period of exclusivity for this new OTC formulation.
