FDA approves Tylenol with Naproxen, the first nonprescription tablet combining acetaminophen and naproxen sodium. The medicine targets persistent minor pain for up to 12 hours, reports the Baltimore Chronicle. The approval was confirmed by the U.S. Food and Drug Administration and Kenvue.
How Tylenol with Naproxen works
The new OTC pain reliever combines 650 mg of acetaminophen with 220 mg of naproxen sodium. Acetaminophen provides faster relief, while naproxen has a longer anti-inflammatory effect.
Kenvue says the tablet begins working within 30 minutes. One dose can relieve pain for up to 12 hours. It is the first FDA-approved OTC fixed-dose product containing both ingredients.
Eight clinical studies compared the combination with each ingredient used separately. According to Kenvue, the combined medicine produced stronger pain relief.
Which types of pain the medicine treats
The FDA approved Tylenol with Naproxen for adults and children aged 12 or older. It provides temporary relief from several common conditions:
- headaches;
- backaches and muscle aches;
- toothaches;
- menstrual cramps;
- minor arthritis pain.
The product is non-opioid and will be sold without a prescription. Consumers must still follow the package directions and consider medicines already containing acetaminophen or naproxen.
Key facts about the FDA approval
The main characteristics announced by regulators and Kenvue are summarized below.
| Detail | Approved information |
|---|---|
| Product | Tylenol with Naproxen |
| Active ingredients | Acetaminophen and naproxen sodium |
| Status | Over-the-counter medicine |
| Onset | Within 30 minutes |
| Duration | Up to 12 hours |
| Minimum age | 12 years |
| Market exclusivity | 3 years |
The FDA listed the product as a notable drug approval on July 24, 2026. Kenvue received 3 years of market exclusivity for the fixed-dose combination.
Kenvue has not announced an exact nationwide retail launch date. Availability, packaging and final label instructions should become clearer before sales begin.
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