The U.S. Food and Drug Administration gave the green light on Friday to a new nonprescription combination pill that brings together Kenvue’s Tylenol and the anti-inflammatory drug naproxen, offering users up to 12 hours of pain relief without a doctor’s prescription.
The pill is approved for use by adults and children 12 years of age and older. It can be taken for a range of common ailments, including headaches, back pain, muscle aches, toothaches, menstrual cramps, and minor arthritis pain.
Each tablet contains 325 milligrams of Tylenol alongside 110 milligrams of naproxen sodium.
The FDA noted that the approval is in line with the Trump administration’s “The Great Healthcare Plan,” a federal initiative aimed at expanding the availability of verified safe medications for over-the-counter purchase.
The approval arrives at a time when Tylenol has been under increased scrutiny. Federal health officials have raised concerns about a possible connection between Tylenol use during pregnancy and autism — though no definitive scientific evidence has established such a link.
That ongoing debate has spilled into the courts. The state of Texas filed a lawsuit against Kenvue, alleging the company failed to adequately warn pregnant consumers about the potential risks. Earlier this month, a federal appeals court also revived more than 500 private lawsuits making similar allegations.
On the business front, Kenvue reached an agreement last November to be acquired by Kimberly-Clark — the company known for making Kleenex tissues — in a deal valued at more than $40 billion. That transaction is expected to be completed sometime this year.
