Ask The Pharmacist: New OTC Opioid Alternative Available for Pain Medication

What should adjusters know about the newly approved Tylenol^® with Naproxen?

On July 24, 2026, the U.S. Food and Drug Administration approved Tylenol with Naproxen, as the first over-the-counter (OTC) combination product containing acetaminophen and naproxen. The approval introduces a new non-opioid approach for common pain conditions that simplifies dosing for patients taking these medications separately. For adjusters, the approval is notable for medication considerations for minor musculoskeletal pain, especially when injured employees are using or considering OTC pain relievers.

What Is Tylenol with Naproxen?

This product combines the rapid pain relief of acetaminophen with the extended duration of naproxen sodium, offering up to 12 hours of pain relief in a single dose. This medication is used for the temporary relief of minor aches and pains such as headaches, backaches, minor arthritis or muscular aches.

Each tablet contains 325 mg of acetaminophen and 110 mg of naproxen sodium. This combination leverages two distinct pain-relief mechanisms. By combining these into a single dose, the product delivers both quick pain relief and prolonged duration.

Clinical studies found the fixed-dose combination provided superior pain relief compared to acetaminophen or naproxen sodium alone. Findings also included the onset of pain relief in under 30 minutes lasting up to 12 hours. This product is particularly useful for patients who would otherwise alternate or combine acetaminophen and naproxen independently. The studies also suggested the combination as an option for patients seeking an OTC opioid-free alternative for longer-lasting pain relief.

Safety Considerations

As with all products containing acetaminophen and non-steroidal anti-inflammatory drugs or NSAIDs adjusters should be aware of several safety considerations:

Acetaminophen-Related Risks

• Avoid using this product with other acetaminophen-containing products
• Excessive acetaminophen exposure can cause severe liver injury

NSAID-Related Risks

• NSAIDs can increase the risk of stomach bleeding
• Increased risk of heart attack, stroke, and heart failure, especially with excessive or prolonged use
• Use caution in patients with cardiovascular disease, gastrointestinal risk factors, or renal impairment

Pregnancy Considerations

• Patients who are pregnant, could become pregnant or are breastfeeding should consult a healthcare professional before use
• Naproxen sodium should generally be avoided at 20 weeks or later in pregnancy unless specifically directed by a physician 

Workers' Compensation Considerations

Although Tylenol with Naproxen is an OTC product, its approval will likely influence pain management strategies for adjusters in workers' compensation programs by:

• Providing an evidence-based, opioid-free option for acute musculoskeletal pain
• Reducing the need for multiple OTC analgesics administered separately
• Potential incorporation into formulary recommendations and first-line treatment for appropriate injuries
• Depending on price, this medication could offer a low-cost alternative to prescription combination analgesics for some patients

For workers' compensation programs, this product provides an accessible OTC option for temporary relief of minor aches and pains, creating an additional tool to support pain management and reduce reliance on prescription analgesics.  

This information is meant to serve as a general overview, and any specific questions should be fully reviewed with a health care professional such as the prescribing doctor or dispensing pharmacist.

Do you have a workers’ compensation or auto-related pharmacy question? Send us an email at AskThePharmacist@enlyte.com. 

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