Two Pain Drugs Used by Millions Will Be Combined in a Single Tablet
Consumers will soon have a new over-the-counter pain relief option that combines Tylenol with naproxen, an anti-inflammatory medication.
The Food and Drug Administration on July 24 approved the non-prescription combination of 650 mg of Tylenol (acetaminophen) and 220 mg of naproxen sodium.
The non-opioid tablet can be used by adults and children aged 12 and older for temporary relief of headaches, back pain, muscle aches, toothache, menstrual cramps and minor pain from arthritis, the FDA said.
Kenvue, which owns Tylenol, said the tablet combination will soon be available for purchase without a prescription at major retailers.
Acetaminophen and naproxen sodium are widely used as over-the-counter pain relievers but until now have not been combined in a single tablet. The combination provides a non-prescription option to give consumers up to 12 hours of pain relief, the FDA said.
The medications work differently. Tylenol quickly reduces pain signals while naproxen sodium targets pain associated with inflammation, said Michelle Bateson, who oversees North America research and development at Kenvue, Tylenol’s parent company.
The combination was evaluated across eight clinical studies and demonstrated “superior pain relief” compared to the individual medications, Bateson said.
About 75% of persistent pain sufferers reported dissatisfaction with their current relief options, according to Kenvue’s March 2026 survey of more than 6,200 people.
In a news release, the FDA said the approval aligns with President Donald Trump’s “great healthcare plan,” which aims to make safe pharmaceutical drugs available for over-the-counter purchase.
In 2025, Trump and his top health officials urged pregnant women to stop taking Tylenol as he promoted an unproven link between the painkiller and a rise in autism among children.
Doctors and medical groups have said acetaminophen is the preferred treatment for pain and fever during pregnancy, and Kenvue has long said that Tylenol is safe.
In 2025, Texas sued Kenvue over alleged failures to warn consumers about the risks of taking the drug while pregnant. More recently, a U.S. appeals court revived more than 500 private lawsuits making similar claims.
Reporting by Ken Alltucker, USA TODAY.
