FDA approves first OTC Tylenol-naproxen combo for 12-hour relief
TL;DR Summary
The FDA approved a non-prescription pill that combines 650 mg acetaminophen (Tylenol) with 220 mg naproxen sodium for adults and children 12 and older, offering up to 12 hours of relief for headaches, back pain, muscle aches, toothache, menstrual cramps, and minor arthritis pain. Developed by Kenvue, the pill is expected to be sold at major retailers and was supported by eight clinical studies showing superior relief compared to the individual drugs.
- Two pain drugs used by millions will be combined in a single tablet USA Today
- US FDA approves over-the-counter Tylenol combination pill for pain relief Reuters
- FDA approves Tylenol® with Naproxen, the first and only over-the-counter fixed-dose combination of acetaminophen (650 mg) and naproxen sodium (220 mg) Kenvue
- FDA Approves First OTC Acetaminophen–Naproxen Combination for Up to 12 Hours of Pain Relief Consultant360
- FDA approves acetaminophen-naproxen sodium combination tablet for ages 12 and older Contemporary Pediatrics
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