Guaifenesin

Reckitt has announced that the U.S. Food and Drug Administration (FDA) has approved Mucinex 12HR Cold and Fever Multi-Symptom, making it the first Over-the-Counter (OTC) innovation in the cold and flu category to receive FDA approval in 14 years. The approval also marks the first New Drug Application (NDA) approved under the Reckitt name, representing a major regulatory milestone for the consumer health company. The newly approved medicine was developed following more than a decade of scientific research, product development, clinical evaluation and regulatory collaboration. Designed to reflect evolving consumer preferences for convenient, long-lasting symptom management, the product aims to provide extended relief from multiple cold and flu symptoms through a single formulation. The approval comes amid a growing burden of seasonal respiratory illnesses in the United States. According to the U.S. Centres for Disease Control and Prevention (CDC), the 2024–25 influenza season resulted in an estimated 51 million illnesses, while the 2025–26 season experienced an early and widespread surge in flu activity. As consumers increasingly rely on OTC medicines as a first line of self-care, demand for safe, effective and longer-lasting treatment options continues to rise. Mucinex 12HR Cold and Fever Multi-Symptom is the first product in its category to combine guaifenesin, dextromethorphan hydrobromide and naproxen sodium, a Non-Steroidal Anti-Inflammatory Drug (NSAID), in a bilayer tablet. The formulation provides both immediate and extended release of its active ingredients, offering symptom relief that lasts for up to 12 hours—up to three times longer than most conventional cold and flu medicines, according to the company. Reckitt said the product was specifically developed to address the inflammatory processes that contribute to many common cold and flu symptoms, delivering sustained multi-symptom relief in a single dose. With the FDA approval, Reckitt is expanding its portfolio of consumer healthcare products while introducing a new treatment option aimed at improving convenience and symptom management for millions of people affected by seasonal cold and flu illnesses.

Company's First New Drug Approval 1 Addresses #1 Unmet Need for Long-Lasting Symptom Relief* Mucinex 12HR Cold & Fever Multi-Symptom is the first and only FDA-approved OTC cold and flu medication that treats fever, cough, chest congestion and body pain for 12 hours This marks the fourth FDA-approval for the Mucinex family of brands Mucinex 12HR Cold & Fever Multi-Symptom is now available at retailers nationwide NUTLEY, N.J., Aug. 5, 2026 /PRNewswire/ -- Reckitt announced today a milestone for the cold and flu category and the company: Mucinex® 12HR Cold & Fever Multi-Symptom is the first U.S. Food and Drug Administration (FDA)-approved over-the-counter (OTC) innovation in the cold and flu category in 14 years, and the first New Drug Application (NDA) under the Reckitt name to receive FDA approval.1 Developed to align with the way consumers choose to manage cold and flu symptoms, this achievement reflects more than a decade of Reckitt's scientific research, development, clinical evaluation and regulatory collaboration. Continue Reading Mucinex 12HR Cold & Fever Multi-Symptom is the first and only FDA-approved OTC cold and flu medication that treats fever, cough, chest congestion and body pain for 12 hours. Mucinex 12HR Cold & Fever Multi-Symptom is the first and only FDA-approved OTC cold and flu medication that treats fever, cough, chest congestion and body pain for 12 hours. Speed Speed The approval comes at a time when cold and flu place an increasingly significant burden on Americans, driving millions of illnesses, healthcare visits and missed days of work and school each year. 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.2 As people continue to rely on OTC medicines as a first line of self-care, expanding access to new innovations that provide safe, effective and convenient symptom relief are more important than ever. "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 advan cing 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." Cold and flu symptoms are largely driven by the body's inflammatory response to infection.3 Recognizing the role that inflammatory processes play in many cold and flu symptoms, Mucinex 12HR Cold & Fever Multi-Symptom was developed to provide long-lasting multi-symptom relief. As 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, it delivers immediate and extended release of active ingredients providing symptom relief that lasts up to three times longer than most cold and flu medications.** "True innovation starts with understanding consumer needs and applying science to solve them," said Angela Naef, Ph.D., 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." About Mucinex 12HR Cold & Fever Multi-Symptom Mucinex 12HR Cold & Fever Multi-Symptom is a first-of-its kind OTC medication designed to address the #1 unmet need in the cold and flu category—long-lasting symptom relief*—delivering up to 12 hours of relief in just one dose. Featuring a patented bi-layer tablet, Mucinex 12HR Cold & Fever Multi-Symptom combines three active ingredients for effective and convenient symptom relief: guaifenesin (expectorant), dextromethorphan HBr (cough suppressant), and naproxen sodium (NSAID for fever and pain). Reckitt launched Mucinex 12HR Cold & Fever Multi-Symptom in 2026, expanding the brand's portfolio of 12-hour products that consumers have trusted for more than 20 years to thin and loosen excess mucus, relieve chest congestion, and control coughing. Backed by more than a decade of scientific research and development, this milestone innovation reflects Reckitt's commitment to advancing science-backed solutions that address meaningful needs in the cold and flu category. About Reckitt We make the products people trust to care for the ones they love. We are home to some of the world's best-loved consumer health and hygiene brands, including Dettol, Durex, Finish, Gaviscon, Harpic, Lysol, Mucinex, Nurofen, Strepsils, Vanish and Veet. Consumers are at the heart of everything we do. By creating innovative, science-backed solutions, we support people every day to live healthier lives. Reckitt exists to protect, heal and nurture in the pursuit of a cleaner, healthier world. This commitment goes beyond the products we make. Through our actions, we expand access to healthcare, education and economic opportunities. We support the planet by reducing waste, conserving resources and driving sustainable innovation. We believe good health starts at home. With every action we take, we strive to make our consumers' lives easier, cleaner and healthier, to strengthen communities and to create a more sustainable future. Find out more or get in touch with us at Reckitt.com/us. Reckitt is the trading name of the Reckitt group of companies *Clear C&F U&A 2022 ** Compared to 1 dose of 4-hour medicine without re-dosing. References 1 U.S. Food and Drug Administration. (2026). Drugs@FDA: FDA-Approved Drugs: Mucinex® 12HR Cold & Fever Multi-Symptom, New Drug Application approval. 2 Centers for Disease Control and Prevention. (2026, July). Vital Statistics Rapid Release, Report No. 44: Mortality in the United States, Provisional Data, 2025. National Center for Health Statistics. 3 Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis 2005 Nov;5(11):718–25 Media Contact: Jen O'Neill Reckitt (U.S) [email protected] Will Hill Reckitt (UK) media&[email protected] SOURCE Reckitt 21% more press release views with Request a Demo