FDA approves Kenvue’s Tylenol with Naproxen as first OTC fixed-dose combination pain reliever

USA—The US Food and Drug Administration (FDA) has approved a new over-the-counter (OTC) pain medication that combines two widely used pain relievers, acetaminophen and naproxen sodium, in a single tablet.

Kenvue, the manufacturer of Tylenol, said the new product, branded Tylenol with Naproxen, contains 650 mg of acetaminophen and 220 mg of naproxen sodium.

The company expects the medication to begin providing pain relief within 30 minutes and remain effective for up to 12 hours.

According to the FDA, the product is the first OTC medicine to combine naproxen sodium with acetaminophen in a fixed-dose formulation.

The approval provides consumers with an additional non-prescription option for managing common types of temporary pain.

Kenvue said the product brings together two established non-opioid pain relievers in a single OTC treatment.

The company added that the combination offers consumers an alternative that does not contain opioids and does not require a prescription.

Approved uses and eligibility

The FDA approved Tylenol with Naproxen for the temporary relief of minor aches and pains associated with several common conditions.

These include headaches, backaches, muscular aches, toothaches, menstrual cramps, and minor arthritis pain.

The product is approved for adults and children aged 12 years and older.

Kenvue said it will soon become available at major retailers across the US, expanding access to the new combination therapy without requiring a prescription.

The FDA also granted Tylenol a three-year period of exclusivity for the new OTC formulation, giving Kenvue a period of market protection for the product.

Kenvue highlights convenience

Dr Rajesh Mishra, chief medical officer at Kenvue, said the approval reflects the company’s efforts to develop accessible OTC pain relief products based on clinical research.

“Persistent pain often leaves people trapped in a cycle of trial and error, navigating between choosing short-term relief or more complex treatment options,” Mishra said.

“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 the fixed-dose formulation could simplify pain management for consumers who might otherwise use separate products containing acetaminophen and naproxen sodium.

FDA warns about acetaminophen use

Despite the product’s OTC status, the FDA continues to warn consumers about the risks associated with excessive acetaminophen use.

Kenvue advises consumers not to take Tylenol with Naproxen alongside other acetaminophen-containing medicines unless directed by a healthcare professional.

Taking multiple acetaminophen-containing medicines can result in an excessive total dose and increase the risk of serious liver damage.

Consumers are therefore advised to check the active ingredients in other medicines they use to avoid accidentally taking more acetaminophen than recommended.

Kenvue said Tylenol with Naproxen will be available at major retailers nationwide in the near future.