The FDA on July 24 approved a first‑of‑its‑kind over‑the‑counter tablet combining 650 mg acetaminophen and 220 mg naproxen sodium, intended for adults and adolescents 12 and older for up to 12 hours of relief from common pains. Kenvue says eight clinical studies showed the combination provided superior relief versus either drug alone, and the product will be available at major U.S. retailers. The approval comes amid debate about acetaminophen use during pregnancy and pending lawsuits against Kenvue.
New OTC Pain Pill: FDA Approves Tylenol (650 mg) Plus Naproxen (220 mg) for Up to 12‑Hour Relief
Two pain drugs used by millions will be combined in a single tablet
The Food and Drug Administration on July 24 approved the first over‑the‑counter single‑tablet combination of 650 mg acetaminophen (Tylenol) and 220 mg naproxen sodium. The non‑opioid tablet is intended for adults and adolescents aged 12 and older for temporary relief of headaches, back pain, muscle aches, toothache, menstrual cramps and minor arthritis pain.
How It Works
The two medicines act through complementary mechanisms: acetaminophen works quickly to reduce pain signaling, while naproxen sodium is a nonsteroidal anti‑inflammatory that targets pain driven by inflammation. Combined in one pill, the FDA says the formulation can provide up to 12 hours of pain relief when used as directed.
Clinical Evidence
Developers evaluated the combination across eight clinical studies. According to Kenvue, the maker of Tylenol, those trials showed the combination produced "superior pain relief" compared with either ingredient taken alone. Kenvue also cited a March 2026 survey of more than 6,200 people reporting that roughly 75% of persistent pain sufferers were dissatisfied with current treatment options.
Availability
Kenvue said the product will soon be sold without a prescription at major retailers across the United States.
Safety Notes and Controversy
The approval arrives amid ongoing debate about acetaminophen use during pregnancy. In 2025, public statements from President Donald Trump and some senior officials urged pregnant women to avoid Tylenol while promoting an unproven link between the drug and increased autism risk in children. Medical organizations and many clinicians continue to recommend acetaminophen as the preferred option for treating pain and fever during pregnancy when used as directed.
Kenvue has faced legal challenges: in 2025 the State of Texas sued the company alleging failures to warn consumers about potential risks of use during pregnancy, and a U.S. appeals court recently revived more than 500 private lawsuits making similar claims.
Note: The FDA said its decision aligns with President Trump’s "Great Healthcare Plan," which the agency described as aiming to make safe pharmaceutical products more widely available over the counter.
As with all medicines, users should follow label directions and consult a healthcare professional with questions—especially pregnant people, nursing mothers, or those with chronic conditions or who take other medications.
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