The Food and Drug Administration approved a new pill Friday that has the active ingredients of both Tylenol and competitor Aleve.
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The medicine will be the first to include both acetaminophen, used in Tylenol, and naproxen sodium, used in Aleve, containing 650 mg of the former and 220 mg of the latter per dose, Tylenol maker Kenvue said in a release.
The product, to be sold as “Tylenol with Naproxen,” promises 12 hours of relief starting within 30 minutes of taking a pill.
Each standard dose is two pills, with each pill containing 325 milligrams of acetaminophen and 110 milligrams of naproxen sodium, according to a Friday release from the Food and Drug Administration.
Acetaminophen and naproxen sodium also meet different needs, with the former ingredient reducing pain signals and the latter going after pain caused by inflammation, Michelle Bateson, who has oversight over research and development for North America at Kenvue, told USA Today.
Kenvue also contended that its new pill could provide an alternative to the use of prescription opioids, since it combines two ingredients used in over-the-counter painkillers. The company will have three years of exclusivity in selling the formula to customers.
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The FDA said in its release that approving the new drug is part of a Trump administration push to “make more verified safe pharmaceutical drugs available for over-the-counter purchase” and “lower healthcare costs and increase consumer choice by strengthening price transparency, increasing competition, and reducing the need for costly and time-consuming doctor’s visits.”
Previously in September 2025, President Trump linked the use of Tylenol during pregnancy to children having autism following a review by Health and Human Services Secretary Robert F. Kennedy Jr.
Kenvue said at the time that “we believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise.”
The president’s linkage of autism and acetaminophen was also rejected by the American College of Obstetricians and Gynecologists.
The FDA release made no mention of the acetaminophen-autism theory, but the agency did say that “the label advises that those who are pregnant or breast-feeding ask a health professional before use.”
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