The US Food and Drug Administration has approved Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg tablets), the first nonprescription fixed-dose combination product containing acetaminophen and naproxen sodium. The over-the-counter product is indicated for the temporary relief of minor aches and pains associated with headache, backache, muscular aches, toothache, menstrual cramps, and minor arthritis pain in adults and pediatric patients aged 12 years and older.

According to the US Food and Drug Administration (FDA), other combination products containing acetaminophen and a nonsteroidal anti-inflammatory drug (NSAID) are available, but Tylenol with Naproxen is the first fixed-dose combination of acetaminophen with naproxen sodium. The product is dosed every 12 hours and is labeled for up to 12 hours of pain relief.

The FDA stated that approval was supported by evidence demonstrating the effectiveness and safety of the fixed-dose combination and the contribution of each active ingredient to the overall analgesic effect. The product labeling is consistent with other nonprescription acetaminophen- and NSAID-containing products and includes standard warnings for both drug classes.

The Drug Facts label warns consumers not to use the product with other acetaminophen-containing medications because doing so may cause liver damage. Consistent with labeling for other NSAID-containing products, the label also includes warnings regarding stomach bleeding and an increased risk for heart attack, heart failure, and stroke. The FDA notes that these risks increase when NSAIDs are taken at doses or for durations that exceed labeled directions.

The labeling also includes pregnancy recommendations consistent with other nonprescription acetaminophen- or NSAID-containing products. Patients who are pregnant or breast-feeding are advised to ask a health care professional before use. The Drug Facts label also advises against using naproxen sodium at 20 weeks of pregnancy or later unless specifically directed by a physician.

The FDA encourages consumers to read and follow the Drug Facts label and to consult a health care professional if they have questions about appropriate use. Kenvue Brands LLC manufactures Tylenol with Naproxen.

Source: US Food and Drug Administration