The U.S. Food and Drug Administration (FDA) approved Kenvue’s new over-the-counter (OTC) pain medication. This first-of-its-kind tablet combines acetaminophen, the active ingredient in Tylenol, with naproxen sodium, the active ingredient in Aleve.
The medication treats minor aches and pains in adults and children aged 12 and older. Kenvue reports the product begins working in under 30 minutes. The formulation provides pain relief for up to 12 hours.
The FDA granted Kenvue a three-year period of market exclusivity for the new OTC formulation. This development represents a significant shift in the consumer healthcare sector.