Millions of Americans live with persistent pain, but over-the-counter options often fall short on strength and duration. That’s why TYLENOL® just introduced TYLENOL® with Naproxen—the first and only FDA-approved OTC fixed-dose combination of acetaminophen and naproxen sodium. It is a clinically proven, opioid-free OTC option that begins working in under 30 minutes and provides 12 hours of pain relief in a single dose. Here’s what it is, how it works and why it matters.
- TYLENOL® with Naproxen is the first and only FDA approved over the counter (OTC) pill to combine acetaminophen and naproxen sodium.
- It combines 650 mg of acetaminophen with 220 mg of naproxen sodium in one potent, opioid-free dose.
- TYLENOL® with Naproxen starts working in under 30 minutes and continues to be effective for 12 hours.
- It is clinically proven to be more effective than Aleve 220 mg.*
- The FDA has granted Kenvue a 3-year period of exclusivity to bring this new over-the-counter formulation to market.
*Compared to Aleve 220 mg or naproxen sodium 220 mg
O que é Tylenol® com naproxeno?
TYLENOL® with Naproxen is a new over-the-counter pain reliever from TYLENOL®, the #1 doctor-recommended pain relief brand with a 70-year legacy of care-driven innovation. It is the first and only FDA-approved fixed-dose combination of acetaminophen and naproxen sodium available over the counter. It combines two complementary pain relievers in one dose:
- 650 mg of acetaminophen
- 220mg of naproxen sodium
Como funciona o Tylenol® com naproxeno?
TYLENOL® with Naproxen combines the fast action of acetaminophen with the long-lasting analgesia of naproxen sodium.
It starts working in under 30 minutes and continues to be effective for 12 hours. In a clinical study, this fixed-dose combination relieved pain better than either acetaminophen (650 mg) or naproxen sodium (220 mg) alone, with meaningful pain relief faster than naproxen sodium (220 mg) and kept working through 12 hours.
Why is there a need for more OTC pain relief options?
For millions of Americans, persistent pain is a constant, invisible weight* that shapes daily life. Pain, including the kind studied in post-surgical pain models, has long required a multi-step approach, often involving trial and error or prescription options.
Current solutions often fall short. In a KVUE Pain Consumer Survey conducted in março de 2026 among 6,240 respondents, 75% of sufferers said they were dissatisfied with their relief options.
There is also continued need for safe, effective non-opioid options. The U.S. Department of Labor reports that up to 1 in 4 patients prescribed opioids are at risk of addiction.
TYLENOL® with Naproxen helps meet this need by offering a stronger† OTC option that lasts 12 hours and is available without a prescription or opioid risk. It gives consumers and healthcare providers another clinically studied choice for managing pain.
*Source: CDC NHAMCS 2022 Emergency Department Data
†Compared to Aleve 220 mg or naproxen sodium 220 mg
Why is this an important innovation in the OTC pain category?
TYLENOL® with Naproxen builds on the brand’s long history of advancing pain relief science, safety and stewardship—from acetaminophen leadership to innovations like caplets, gel caps, easy-to-swallow formats and children’s liquid acetaminophen. This new formulation brings that legacy into the OTC pain category with a first-of-its-kind multimodal option designed to provide strong, long-lasting relief.
This new fixed-dose combination has been rigorously evaluated through eight distinct clinical studies, including post-surgical pain models. TYLENOL® with Naproxen provides a stronger* solution that lasts 12 hours and is available without a prescription or opioid risk.
Across clinical studies, TYLENOL® with Naproxen demonstrated:
- Good, very good, or excellent pain relief ratings from 90.6% of patients†
- Superior pain relief compared with acetaminophen (650 mg) and naproxen sodium (220 mg) over a 12-hour period†
- Meaningful pain relief faster than naproxen sodium (220 mg) and lasting longer than acetaminophen†
- Nearly 40% less opioid rescue medication use over 48 hours‡
In recognition of this innovation, the FDA has granted Kenvue a 3-year period of exclusivity to bring this new over-the-counter formulation to market.
*Compared to Aleve 220mg or naproxen sodium 220mg.
† Based on testing in moderate-to-severe post-surgical dental pain, where the acetaminophen and naproxen sodium combination outperformed both acetaminophen and naproxen sodium alone over a 12-hour period, delivered meaningful pain relief faster than naproxen sodium and lasted longer than acetaminophen.
‡ Based on testing in moderate-to-severe post-bunionectomy pain, where the acetaminophen and naproxen sodium combination reduced total opioid rescue medication use over 48 hours by nearly 40% vs. the placebo.