The US Food and Drug Administration has approved Tylenol with Naproxen, the first over-the-counter fixed-dose combination of 650 mg acetaminophen and 220 mg naproxen sodium.
According to manufacturer Kenvue, the medicine begins working in under 30 minutes and may provide pain relief for up to 12 hours.
The combination was evaluated in eight clinical studies. Results indicated greater pain relief compared with products containing either acetaminophen or naproxen sodium alone.
The product provides an additional non-opioid, non-prescription option for people seeking relief from persistent pain.
Tylenol with Naproxen is expected to become available soon through major US retailers. The FDA approval also grants Kenvue three years of exclusivity for the new OTC formulation.