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

July 24 (Reuters) – The U.S. Food and Drug Administration on Friday approved a nonprescription, fixed-dose pill that combines Kenvue’s 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 for more than $40 billion. The transaction is expected to close this year.

(Reporting by Christy Santhosh in Bengaluru; Editing by Tasim Zahid)