The FDA on July 24 approved Tylenol with Naproxen, the first fixed‑dose OTC tablet combining acetaminophen and naproxen sodium. Kenvue cites eight clinical studies showing faster and stronger pain relief than either drug alone, often within 30 minutes, and up to 12 hours of relief for ages 12 and up. The manufacturer says the product is intended to simplify persistent pain management as a multimodal, non‑opioid OTC option; consumers should follow label directions and consult a clinician if they have health concerns.
FDA Clears First Over-The-Counter Tylenol With Naproxen Tablet — Up To 12 Hours Of Relief
The U.S. Food and Drug Administration on July 24 approved Tylenol with Naproxen, a fixed‑dose over‑the‑counter tablet that combines acetaminophen (Tylenol) with naproxen sodium — the first OTC product to pair these two nonprescription pain relievers in a single tablet, Kenvue Brands said in a release.
Clinical Evidence: According to Kenvue, data from eight clinical studies showed the combination provided stronger pain relief than either acetaminophen or naproxen alone and that many participants reported relief within about 30 minutes. The FDA noted the product is intended to deliver up to 12 hours of pain relief for adults and adolescents ages 12 and older.
Why It Matters: Kenvue positioned the fixed‑dose option as a way to simplify care for people managing persistent pain who otherwise juggle multiple medicines, staggered dosing schedules or prescription therapies. The company described the tablet as a multimodal, non‑opioid OTC option designed to support adherence and sustained relief.
Safety And Use: This product is for adults and children 12 and older; it is important to follow the label directions and not exceed the recommended daily dose. Because the tablet combines an acetaminophen (which can cause liver damage in overdose) and an NSAID (which can increase risk of gastrointestinal bleeding, cardiovascular events, or kidney effects in some people), consumers with chronic health conditions or those taking other medications should consult a healthcare professional before use. Always read the full Drug Facts panel on the package.
What’s Next: Kenvue announced the approval in its release; consumers should watch for availability and retailer announcements for purchase timing and pricing.
Source: U.S. Food and Drug Administration; Kenvue Brands release. Copyright 2026 Nexstar Media, Inc. All rights reserved.
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