US FDA clears first over-the-counter acetaminophen-naproxen painkiller

The US Food and Drug Administration (FDA) has approved Tylenol with Naproxen, the first over-the-counter pain medication to combine acetaminophen (paracetamol) and naproxen sodium.

The FDA said each tablet contains 325 mg of acetaminophen and 110 mg of naproxen sodium, Caliber.Az reports.

The medication is intended for the temporary relief of headaches, toothaches, muscle pain, menstrual cramps, back pain and minor arthritis pain.

It is approved for use by adults and children aged 12 and older, with dosing every 12 hours.

According to the FDA, combination products containing acetaminophen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are already available, but Tylenol with Naproxen is the first to combine these two specific active ingredients.

The approval was based on data demonstrating the combination's safety and effectiveness.

The regulator warned that the medication should not be taken with other acetaminophen-containing products because of the risk of liver damage.

Like other NSAIDs, it also carries warnings about potential stomach bleeding, heart attack, heart failure and stroke, particularly with excessive or prolonged use.

The drug is manufactured by Kenvue Brands LLC.

By Bakhtiyar Abbasov