The United States Food and Drug Administration (FDA) has approved a non-prescription, fixed-dose pain relief pill that combines Kenvue’s Tylenol with the non-steroidal anti-inflammatory drug (NSAID) naproxen, offering up to 12 hours of pain relief.
The newly approved medicine is intended for adults and children aged 12 years and above. It can be used to treat headaches, back pain, muscle aches, toothaches, menstrual cramps and minor arthritis pain.
Each tablet contains 325 milligrams of Tylenol (acetaminophen) and 110 milligrams of naproxen sodium. The FDA said the approval supports President Donald Trump’s “The Great Healthcare Plan”, an initiative aimed at making more verified safe pharmaceutical products available for over-the-counter purchase.
The approval comes as Tylenol continues to face legal and public scrutiny over allegations that its use during pregnancy may be linked to autism in children. However, there is currently no conclusive scientific evidence establishing such a connection.
The controversy has led to legal action against Kenvue. The State of Texas has sued the company, alleging it failed to adequately warn pregnant consumers about potential risks. In addition, a United States appeals court recently reinstated more than 500 private lawsuits raising similar claims.
Separately, Kenvue announced last November that it had agreed to be acquired by tissue manufacturer Kimberly-Clark in a deal valued at more than US$40 billion. The transaction is expected to be completed later this year.
