US FDA approves over-the-counter Tylenol combination pill for pain relief

Kenvue

24/07/2026 16:56

    July 24 (Reuters) - 
    The U.S. Food and Drug Administration on Friday approved a nonprescription, fixed-dose pill that combines Kenvue's KVUE.N Tylenol with the nonsteroidal anti-inflammatory drug naproxen for up to 12 hours of pain relief.
  
Here are some details:
The pill can be used by adults and children aged 12 and older for headaches, back pain, muscle aches, toothaches, menstrual cramps and minor arthritis pain.

        The FDA said the approval aligns with Trump's "The Great Healthcare Plan," a federal effort to make more verified safe pharmaceutical drugs available for over-the-counter purchase.
      
Each pill contains 325 milligrams of Tylenol and 110 milligrams of naproxen sodium.
Tylenol has been under scrutiny after U.S. health officials raised concerns about an alleged link between Tylenol use during pregnancy and autism. There is no firm scientific evidence of such a link.
The debate has also triggered legal action, as Texas sued Kenvue over alleged failures to warn pregnant consumers, and a U.S. appeals court this month revived more than 500 private lawsuits making similar claims.
Kenvue agreed last November to be acquired by Kleenex tissue maker Kimberly-Clark KMB.O for more than $40 billion. The transaction is expected to close this year. 



 (Reporting by Christy Santhosh in Bengaluru; Editing by Tasim Zahid)
 ((Christy.Santhosh@thomsonreuters.com;))