Reckitt’s Mucinex 12HR Cold & Fever Multi-Symptom is the first US Food and Drug Administration (FDA)-approved over-the-counter (OTC) drug in the cold and flu category in 14 years. 

Mucinex that treats fever, cough, chest congestion and body pain for 12 hours. 

According to The Centers for Disease Control and Prevention (CDC), the 2024-25 flu season resulted in an estimated 51 million illnesses, while the 2025-26 season saw a surge in flu cases across the country that coincided with an earlier flu season. 

“This milestone reinforces Reckitt’s commitment to delivering trusted, science-backed solutions that meet everyday health needs and truly fit how Americans live,” said Jérôme Lemaire, President, Reckitt North America. “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.” 

Recognising the role that inflammatory processes play in many cold and flu symptoms, Mucinex was developed to provide long-lasting multi-symptom relief. It is the first product in its category to combine guaifenesin, dextromethorphan HBr, and naproxen sodium, an NSAID (non-steroidal anti-inflammatory drug), in a bilayer tablet. 

“True innovation starts with understanding consumer needs and applying science to solve them,” said Angela Naef, Chief R&D Officer, Reckitt. “This approval is the culmination of more than a decade of research and development to create a first-of-its-kind formulation that delivers long-lasting relief from multiple cold and flu symptoms.”