The U.S. Food and Drug Administration has approved Tylenol with Naproxen, marking the first time a fixed-dose combination of acetaminophen and naproxen sodium has been approved for nonprescription use. The product provides up to 12 hours of pain relief in a single tablet.
The approved product contains 325 mg of acetaminophen and 110 mg of naproxen sodium per tablet. It is indicated for the temporary relief of minor aches and pains related to headaches, backaches, muscular aches, toothaches, menstrual cramps, and minor arthritis pain. The medication is intended for use in adults and children 12 years of age and older.
This approval is part of a federal effort known as President Trump's The Great Healthcare Plan, which aims to make more verified safe pharmaceutical drugs available for over-the-counter purchase. This initiative is intended to lower healthcare costs and increase consumer choice by strengthening price transparency, increasing competition, and reducing the need for costly doctor visits.
Kenvue Brands LLC manufactures Tylenol with Naproxen. The approval was supported by evidence demonstrating the safety and effectiveness of the combination and how each ingredient contributes to overall pain relief.
The FDA has issued specific safety warnings for the new product. Consumers are advised not to use Tylenol with Naproxen with other medications containing acetaminophen due to the risk of liver damage. Because it contains a nonsteroidal anti-inflammatory drug (NSAID), the labeling includes warnings regarding stomach bleeding and an increased risk of heart attack, stroke, or heart failure if used longer or more frequently than directed.
Regarding pregnancy, the label advises pregnant or breastfeeding individuals to consult a health professional before use. The Drug Facts label also states that naproxen sodium should not be used at 20 weeks or later during pregnancy unless directed by a doctor.
The FDA encourages all consumers to carefully read and follow the product labeling and to consult a healthcare provider with any unanswered questions.
