TYLENOL® with Naproxen is a clinically proven, opioid-free, fixed-dose combination that begins working in under 30 minutes and provides 12 hours of pain relief in a single dose.

  • FDA-approved first and only OTC fixed‑dose combination of acetaminophen and naproxen sodium, expanding non-opioid options for persistent pain.
  • Addresses a critical gap in persistent pain relief – 75% of persistent pain sufferers report dissatisfaction with current options (Kenvue Pain Consumer Survey, March 2026, n=6,240).
  • Simplifies pain management with a single, clinically proven fixed-dose combination, eliminating the need to time or coordinate multiple over-the-counter pain relievers.
  • Backed by eight clinical studies demonstrating superior pain relief versus acetaminophen alone and naproxen sodium alone (Aleve1 220 mg).
  • Builds on more than 70 years of TYLENOL® leadership in pain relief innovation, advancing a more streamlined, multimodal approach for patients and healthcare providers.

SUMMIT, N.J., July 24, 2026 /PRNewswire/ -- TYLENOL®, the #1 doctor‑recommended pain relief brand, today announced that the U.S. Food and Drug Administration (FDA) has approved TYLENOL® with Naproxen — the first and only over‑the‑counter (OTC) fixed‑dose combination of acetaminophen and naproxen sodium — redefining what's possible in non-prescription pain management. TYLENOL® with Naproxen combines the fast-acting relief of 650 mg of acetaminophen with the long-lasting analgesic power of 220 mg naproxen sodium (a non-steroidal anti-inflammatory drug) in one dose, which begins working in under 30 minutes and provides relief for 12 hours.