Naproxen-Powered Pain Relief Medications

Kenvue Receives FDA Approval for TYLENOL with Naproxen

Kenvue Inc. has received FDA approval for TYLENOL with Naproxen — the first and only over-the-counter fixed-dose combination of 650 milligrams of acetaminophen and 220 milligrams of naproxen sodium. This product offers a non-opioid pain relief option that begins working in under 30 minutes and provides 12 hours of relief from a single dose.

The TYLENOL with Naproxen formulation is backed by eight clinical studies demonstrating superior pain relief compared to either ingredient alone, and it addresses a critical gap identified in a Kenvue consumer survey where 75% of persistent pain sufferers expressed dissatisfaction with current options. The fixed-dose combination simplifies pain management by eliminating the need for patients to time or coordinate multiple over-the-counter products.

The FDA has granted a three-year exclusivity period for this formulation.

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