New Pain Reliever Combines Tylenol and Naproxen
/By Crystal Lindell
Pain sufferers will soon be able to buy a new over-the-counter medication that combines acetaminophen with naproxen.
That’s thanks to the FDA approving new “Tylenol with Naproxen.” A two-tablet dose contains 650 mg of acetaminophen and 220 mg of naproxen sodium. Many consumers know acetaminophen as the brand name Tylenol, while naproxen is known by the brand name Aleve.
The non-prescription pain reliever is approved for minor aches and pains such as headaches, backaches, sore muscles, toothaches, menstrual cramps, and arthritis pain in adults and children 12 years and older.
The new tablets start working within about 30 minutes because of the acetaminophen, while the non-steroidal anti-inflammatory drug (NSAID) naproxen provides 12 hours of extended pain relief.
Acetaminophen is believed to work more quickly to reduce pain signals, while naproxen provides longer-lasting relief by targeting pain caused by inflammation.
The FDA granted Kenvue, which makes the Tylenol brand, a three-year period of exclusivity for this new OTC formulation. That means there will be no generic alternative available in that time.
In a press release, Kenvue cited a recent company survey showing that 75% of pain sufferers report dissatisfaction with their current options.
“Persistent pain often leaves people trapped in a cycle of trial and error, navigating between choosing short-term relief or more complex treatment options,” said Rajesh Mishra, MD, Chief Medical Officer of Kenvue. “Tylenol with Naproxen simplifies that choice, offering fast onset, 12-hour duration, and the safety profile of two well-established non-opioid ingredients in one fixed-dose.”
The company said its research showed that Tylenol with Naproxen demonstrated superior pain relief versus using either medication alone. It didn’t provide a price or date for when the tablets will be available, only that they are “coming soon to major U.S. retailers nationwide.”
Company Touts ‘Opioid-Free’ Label
The press release touts the fact that the medication is "opioid-free" multiple times and claims "up to 1 in 4 patients prescribed opioids are at risk of addiction."
"Tylenol with Naproxen addresses this gap by combining two well-established non-opioid pain relievers into a single, clinically proven OTC therapeutic solution that requires no prescription and carries no opioid risk," the company said.
Most studies show the risk of opioid addiction is very low. Neither Kenvue or the FDA shared any research on whether the new medication was comparable to pain relief from opioids.
And just because there is no opioid-related risk, that doesn't mean there is zero risk. The FDA warned consumers not to use Tylenol with Naproxen with other drugs containing acetaminophen, as doing so may cause liver damage.
And, as with all NSAID-containing products, the labeling includes warnings for stomach bleeding and for increased risk of heart attack, heart failure, and stroke — risks that are higher when NSAIDs are used more than directed or for longer than directed.
While this is the first OTC combination of Tylenol with Naproxen, it is not the first time acetaminophen has been combined with an NSAID in an OTC medication. In 2020, the FDA approved the first over-the-counter pain reliever that combines acetaminophen with ibuprofen, Advil Dual Action.
