US FDA approves over‑the‑counter Tylenol‑naproxen combo pill

The U.S. Food and Drug Administration approved a nonprescription, fixed‑dose pill that combines Kenvue’s Tylenol (acetaminophen) 325 mg with naproxen sodium 110 mg, offering up to 12 hours of pain relief. The product can be used by adults and children aged 12 and older for headaches, back pain, muscle aches, toothaches, menstrual cramps and mild arthritis.

The approval aligns with the federal “Great Healthcare Plan” initiative to expand verified OTC medicines. Tylenol has faced scrutiny over alleged links to autism when used during pregnancy, but health officials say no solid scientific evidence supports the claim. Legal actions continue, including a Texas lawsuit against Kenvue and an appeals‑court revival of more than 500 related lawsuits.

Kenvue, the maker of Tylenol, agreed in November to be acquired by Kimberly‑Clark for over $40 billion, a transaction expected to close later this year.