FDA Approves First Over-the-Counter Tylenol and Naproxen Combination
- The FDA approved the first over-the-counter combination of acetaminophen and naproxen sodium for temporary relief of minor aches and pains.
- Tylenol with Naproxen is approved for adults and children ages 12 and older and provides up to 12 hours of pain relief.
- Consumers should avoid combining it with other acetaminophen or naproxen products because excessive use can cause liver damage, stomach bleeding, heart attack, or stroke.
The U.S. Food and Drug Administration (FDA) has approved the first over-the-counter medication combining acetaminophen, or Tylenol, with naproxen sodium, or Aleve, an anti-inflammatory pain reliever.
The product, Tylenol with Naproxen, is approved for the temporary relief of minor aches and pains in adults and children ages 12 and older. The combination is designed to provide up to 12 hours of pain relief and can be used for things like headaches, backaches, muscle aches, toothaches, menstrual cramps, and arthritis pain.
The medication combines two established pain relievers that work differently. Acetaminophen helps relieve pain, while naproxen sodium is a nonsteroidal anti-inflammatory drug, or NSAID, that can help reduce pain associated with inflammation.
However, health experts say the combination isn’t right for everyone. It’s important to read the Drug Facts label and avoid taking it with other medications containing acetaminophen or naproxen. Acetaminophen can cause liver damage if you take too much, while NSAIDs can increase the risk of stomach bleeding, heart attack, and stroke. People who are pregnant or have certain health conditions should speak with their doctor before using the new medication.
Tylenol with Naproxen is expected to offer people another non-opioid option for managing temporary pain.