Reckitt has received approval from the U.S. Food and Drug Administration for a long-lasting cold and flu symptom-relief medication.

Mucinex 12HR Cold & Fever Multi-Symptom is the first drug to combine the active pharmaceutical ingredients of guaifenesin, dextromethorphan hydrobromide and naproxen sodium in a bilayer tablet, according to the company and the FDA.

The Nutley-based consumer goods company said the over-the-counter cold and flu medication marks the first New Drug Application (NDA) under the Reckitt name to receive FDA approval.

“By advancing the cold and flu category with longer-lasting, 12-hour symptom relief, we are not just expanding consumer choice and access, we are easing the care burden on families and empowering people to stay focused on their daily lives,” Jérôme Lemaire, President, Reckitt North America, said in the Aug. 5 announcement.

About the product

The Mucinex pill provides up to 12 hours of symptom relief in one dose, according to Reckitt. The active ingredients are:

• Guaifenesin: expectorant
• Dextromethorphan HBr: cough suppressant
• Naproxen sodium: non-steroidal anti-inflammatory drug for fever and pain

The medication aims to thin and loosen excess mucus, relieve chest congestion and control coughing.

Angela Naef, Reckitt’s chief R&D officer, said the FDA “approval is the culmination of more than a decade of research and development to create a first-of-its-kind formulation …”

“True innovation starts with understanding consumer needs and applying science to solve them,” Naef said.

In 2025, Reckitt announced it would sell its Essential Home business to private equity firm Advent International in a deal worth $4.8 billion. The move part of the company’s focus shift to core health and hygiene brands. Additional Reckitt brands include Dettol, Durex, Finish, Gaviscon, Harpic, Lysol, Nurofen, Strepsils, Vanish and Veet.