The U.S. Food and Drug Administration has authorized the first over‑the‑counter medication that combines acetaminophen and naproxen sodium in a fixed‑dose tablet. Kenvue Brands received the approval to sell the product under the name Tylenol with Naproxen, stating that each tablet delivers 325 milligrams of acetaminophen and 110 milligrams of naproxen sodium and provides pain relief for up to twelve hours. The FDA clearance covers use by adults and by children aged twelve years and older, and Kenvue Brands will both manufacture and market the new tablet. This regulatory approval marks the introduction of the first OTC acetaminophen‑naproxen combination in the United States.
Kenvue Brands Receives FDA OTC Acetaminophen-Naproxen Approval
Product Launch / New Business
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