FDA Approves First Over-the-Counter Pill Combining Tylenol and Naproxen

WASHINGTON — The Food and Drug Administration on Friday approved the first over-the-counter tablet that combines acetaminophen, the active ingredient in Tylenol, with the anti-inflammatory drug naproxen sodium, offering consumers a new option for up to 12 hours of pain relief.

The product, called Tylenol with Naproxen, contains 325 milligrams of acetaminophen and 110 milligrams of naproxen sodium per tablet and is dosed every 12 hours, according to the FDA. Manufacturer Kenvue describes a typical dose as two tablets, delivering 650 milligrams of acetaminophen and 220 milligrams of naproxen sodium.

Approved Uses

The nonprescription medicine is indicated for temporary relief of minor aches and pains from headache, backache, muscle aches, toothache, menstrual cramps and minor arthritis pain in adults and children 12 and older.

Combination products pairing acetaminophen with other nonsteroidal anti-inflammatory drugs, or NSAIDs, are already sold in the United States, but this is the first to combine acetaminophen with naproxen sodium, the FDA said. The agency said the approval was supported by evidence showing the combination’s safety and effectiveness and demonstrating that each ingredient contributes to the overall pain relief.

Part of Administration Push

The FDA said the approval aligns with President Donald Trump’s Great Healthcare Plan, a federal effort to make more verified safe drugs available without a prescription. The agency said expanding over-the-counter options can lower health care costs, increase consumer choice and reduce the need for doctor’s visits.

Safety Warnings

The product’s labeling carries the standard warnings for both acetaminophen and NSAIDs. Consumers are cautioned not to take it with other medicines containing acetaminophen, because doing so can cause liver damage. As with all NSAID products, the label also warns of the risk of stomach bleeding and an increased risk of heart attack, heart failure and stroke, risks that rise when the drugs are taken in higher doses or for longer than directed.

The labeling also includes pregnancy-related recommendations consistent with other acetaminophen and NSAID products sold without a prescription.

Availability

Kenvue, the consumer health company that markets Tylenol, said the product would be available soon at major U.S. retailers. Acetaminophen and naproxen sodium are among the most widely used over-the-counter pain relievers in the country, each with decades of use.

Pharmacists and physicians generally advise consumers to read labels carefully, use the lowest effective dose for the shortest time needed and consult a health professional if they take other medications, have liver or kidney disease, or have a history of stomach ulcers or heart problems.