The Food and Drug Administration Approves New Tylenol with Naproxen Combination for Over-the-Counter Pain Relief
The Food and Drug Administration has approved a new non-prescription pain relief option that combines 650 mg of acetaminophen with 220 mg of naproxen sodium in a single tablet. This first-of-its-kind fixed-dose combination provides 12 hours of relief for headaches, back pain, and muscle aches, starting to work in under 30 minutes. Michelle Bateson of Kenvue, the parent company of Tylenol, stated that the combination was evaluated across eight clinical studies and demonstrated superior pain relief compared to the individual medications. The administration announced that this approval aligns with President Trump's 'great healthcare plan,' which aims to make safe pharmaceutical drugs available for over-the-counter purchase. While the new tablet offers a non-opioid alternative for persistent pain sufferers, Kenvue has faced some scrutiny. In 2025, Texas sued Kenvue over alleged failures to warn consumers about the risks of taking Tylenol while pregnant, a claim that has been revived by a U.S. appeals court in over 500 private lawsuits.