A new version of over-the-counter Tylenol - this one combined with naproxen sodium - has gotten approval from the Food and Drug Administration.
The tablet is designed for temporary relief of minor aches and pains, such as headache, backache, muscular aches, toothache, menstrual cramps and minor arthritis pain. Kenvue, which manufactures Tylenol and Tylenol with Naproxen, said the new drug starts working within 30 minutes and offers pain relief for up to 12 hours.
Kenvue said that the new medication will soon be available at shops across the United States.
The federal approval comes despite the Trump administration pushing the idea that Tylenol is dangerous for expecting mothers. Without scientific backing, President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. have said that taking Tylenol while pregnant increases the risk of autism.
The FDA granted Kenvue a three-year period of exclusivity for its new over-the-counter formulation.
“This milestone reflects the long-standing leadership of Tylenol in translating rigorous clinical science into accessible, over‑the‑counter solutions,” said Rajesh Mishra MD, the chief medical officer at Kenvue, in a statement. “Persistent pain often leaves people trapped in a cycle of trial and error, navigating between choosing short-term relief or more complex treatment options.”
The drug combo does not contain opioids. Kenvue noted that the US Department of Labor reports that up to 1 in 4 people prescribed opioids are at risk of addiction.
“Tylenol with Naproxen addresses this gap by combining two well-established non-opioid pain relievers into a single, clinically proven [over-the-counter] therapeutic solution that requires no prescription and carries no opioid risk,” Kenvue officials said in their statement.
Trump has previously made disputed and unproven claims that Tylenol, known as paracetamol elsewhere, is linked to autism and advised pregnant women to stop taking it last September. The American College of Obstetricians and Gynecologists disputed the link made by Trump.
Dr. Steven Fleischman, the president of the group, said the Tylenol claim "is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children."
"Studies that have been conducted in the past, show no clear evidence that proves a direct relationship between the prudent use of acetaminophen during any trimester and fetal developmental issues," the statement added.
