Kit KittlestadJul 27, 2026 3 min read

FDA Approves New Tylenol With an Anti-Inflammatory Pain Reliever

Tylenol capsules for pain relief
The FDA has approved the first over-the-counter pain reliever combining acetaminophen and naproxen sodium for up to 12 hours of relief. | Adobe Stock

If you've ever reached for Tylenol and an anti-inflammatory pain reliever to tackle a stubborn headache or sore back, there's good news.

The FDA has approved the first over-the-counter medication that combines acetaminophen, the active ingredient in Tylenol, with naproxen sodium, a nonsteroidal anti-inflammatory drug (NSAID) commonly found in Aleve. 

The new product is designed to provide up to 12 hours of pain relief in a single dose.

Why Combine These Two Medicines?

Although both medications relieve pain, they work in different ways.

Tylenol with Naproxen. | Tylenol
Tylenol with Naproxen. | Tylenol

Acetaminophen helps to reduce pain and fever, while naproxen sodium targets pain by reducing inflammation. 

Because they complement one another, combining the two may provide longer-lasting relief for common aches and pains than either ingredient alone.

What Can It Treat?

The new pain reliever is approved for adults and children ages 12 and older. 

According to the FDA, it can be used to temporarily relieve a variety of everyday aches and pains, including:

  • Headaches

  • Toothaches

  • Backaches

  • Muscle aches

  • Minor arthritis pain

  • Menstrual cramps

  • The common cold

It may also help to reduce a fever and is intended to provide relief for up to 12 hours.

A Few Important Safety Reminders

Like all medications, this new combination should be used exactly as directed.

Because it contains acetaminophen, it's important not to take it with other products that also contain acetaminophen, as too much can cause serious liver damage.

Tylenol medicine on grocery store shelves
Adobe Stock

The FDA also reminds consumers that naproxen sodium belongs to a class of medicines known as NSAIDs

Particularly if they're used for longer than directed or by people with certain medical conditions, these medications can increase the risk of:

  • Heart attack

  • Stroke

  • Heart failure

  • Stomach bleeding

  • Kidney problems

Be sure to read the Drug Facts label carefully and talk to your doctor if you have questions about whether the medication is right for you.

A New Option for Your Medicine Cabinet

Treating pain often means deciding whether to reach for Tylenol or an anti-inflammatory medication. 

Now, thanks to the FDA's approval of this new combination product, you'll have another option that brings both ingredients together in a single pill. 

As always, be sure to read the label, follow the dosing instructions, and use the medication only as directed for the safest and most effective relief.


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