US FDA Approves Over-the-counter Tylenol Combination Pill for Pain Relief

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)

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