Key facts
- The FDA approved a new over-the-counter pill combining Tylenol and naproxen sodium.
- The pill offers up to 12 hours of pain relief for headaches, back pain, muscle aches, toothaches, menstrual cramps, and minor arthritis pain.
- It is approved for adults and children aged 12 and older.
- Each pill contains 325mg of Tylenol and 110mg of naproxen sodium.
- The FDA cited President Trump's healthcare plan as a reason for approving more over-the-counter drugs.
- Kenvue, the maker of Tylenol, is being acquired by Kimberly-Clark for over $40 billion.
The U.S. Food and Drug Administration has approved a new over-the-counter pill that combines Tylenol (acetaminophen) with naproxen sodium, offering up to 12 hours of pain relief. The medication is intended for adults and children aged 12 and older and can be used for various pain conditions including headaches, back pain, muscle aches, toothaches, menstrual cramps, and minor arthritis pain.
The FDA stated that this approval aligns with President Trump's healthcare initiative aimed at making more verified safe pharmaceutical drugs available over-the-counter. Each pill contains 325 milligrams of Tylenol and 110 milligrams of naproxen sodium.
Separately, Kenvue, the maker of Tylenol, is in the process of being acquired by Kimberly-Clark for over $40 billion, with the transaction anticipated to conclude this year. Tylenol has also been subject to scrutiny regarding potential links between its use during pregnancy and autism, although definitive scientific evidence is lacking. This debate has led to legal actions, including a lawsuit by Texas against Kenvue for alleged failure to warn pregnant consumers, and the revival of over 500 private lawsuits by a U.S. appeals court.