Naproxen Sodium

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

The FDA approval grants Kenvue a three-year exclusivity period for the new OTC formulation. Credit: DC Studio / Shutterstock.com. The US Food and Drug Administration (FDA) has approved Kenvue’s Tylenol with Naproxen, the first over-the-counter (OTC) fixed-dose combination of acetaminophen (650mg) and naproxen sodium (220mg). This combination aims to provide an additional non-opioid pain relief option without the need for prescriptions. The approval introduces a new choice for individuals seeking relief from persistent pain. Tylenol with Naproxen combines acetaminophen, known for its fast-acting effect, with naproxen sodium, a non-steroidal anti-inflammatory drug, which is intended to offer longer-lasting results. The combined formulation begins working in under 30 minutes and delivers pain relief for up to 12 hours. Kenvue cited results from eight clinical studies that evaluated the performance of Tylenol with Naproxen against products containing either acetaminophen or naproxen sodium alone. The company noted that data showed improved pain relief with the fixed-dose combination compared to the individual ingredients. The company referenced findings from the Kenvue Pain Consumer Survey conducted in March 2026, which involved 6,240 respondents. In that survey, approximately 75% of people living with persistent pain reported dissatisfaction with current pain relief methods. Kenvue chief medical officer Dr Rajesh Mishra said: “This milestone reflects the long-standing leadership of Tylenol in translating rigorous clinical science into accessible, over-the-counter solutions. “Persistent pain often leaves people trapped in a cycle of trial and error, navigating between choosing short-term relief or more complex treatment options. “Tylenol with Naproxen simplifies that choice, offering fast onset, 12-hour duration, and the safety profile of two well-established non-opioid ingredients in one fixed-dose.” FDA approval of Tylenol with Naproxen grants Kenvue a three-year period of exclusivity for the new OTC formulation. Tylenol with Naproxen is expected to be available soon at major retailers across the US.