The U.S. Food and Drug Administration (FDA) approved Kenvue’s new over-the-counter (OTC) medication, Tylenol with Naproxen. This product is the first to combine acetaminophen and naproxen sodium in a single, fixed-dose tablet.
The formulation provides pain relief for up to 12 hours. Each pill contains 325 mg of acetaminophen and 110 mg of naproxen sodium.
The approval covers use for adults and children aged 12 years and older. The medication treats minor aches and pains, including headaches, back pain, muscle aches, and minor arthritis pain.
This development marks a significant milestone for Kenvue. The approval potentially enhances the company's product lineup in the consumer health market.