Guaifenesin

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

Some widely used over-the-counter cold and flu medicines may be exposing patients to unexpectedly high amounts of one ingredient, revealing a lapse in regulations and perhaps raising safety concerns, a company that develops such drugs reported on Wednesday. The company, AFT Pharmaceuticals of New Zealand, said that when the nasal decongestant phenylephrine, or PE, was combined with the pain reliever acetaminophen, levels of PE in the blood were two to four times as high as when the same dose of PE was taken alone. “Effectively, accidentally you are getting a higher dose here,” said Hartley C. Atkinson, chief executive for AFT. He and colleagues reported their finding in a brief correspondence published on Wednesday online in The New England Journal of Medicine website. The letter said the combination increased exposure to PE “beyond levels that were previously deemed to be safe and effective.” Drugs that combine PE and acetaminophen, which is the active ingredient in Tylenol, are common and include certain versions of Robitussin, Theraflu, Mucinex, DayQuil, Tylenol Cold and Flu and other brands. AFT sells a combination product in some markets outside of the United States. The potential adverse side effects from a high dose of PE could include higher blood pressure, elevated heart rate and nervousness. The Food and Drug Administration said it was aware of the finding but suggested it was not a safety concern. It said in a statement that PE was generally recognized as safe, including in combination with acetaminophen. The Consumer Healthcare Products Association, which is based in Washington and represents over-the-counter drug manufacturers, also dismissed any concerns, saying PE had been used safely for decades. Ron Eccles, director of the common cold center at Cardiff University in Britain, who was not involved in the study, said that while he did not think there were serious risks, “Regulatory authorities need to address this issue quickly to reassure the public that these freely available medicines are safe.” Still, the F.D.A. declined several years ago to increase the permitted dose of PE to 25 milligrams from 10 milligrams. Dr. Atkinson of ATF said that 10 milligrams of PE taken in combination with acetaminophen leads to blood levels similar to what would come from taking 25 milligrams of PE by itself. The Consumer Healthcare Products Association, in a 2007 document arguing against the dose increase, said that studies had found that the 25- milligram dose was more frequently associated with increased pulse rate and nervousness than the lower dose. An F.D.A. review concluded, however, that past studies “suggest only negligible effects” at either dose. The use of PE as a nasal decongestant increased markedly several years ago after access to another decongestant, pseudoephedrine, was restricted because it was being used to make methamphetamines. Some experts said the finding of the unexpected interaction of acetaminophen and PE showed that over-the-counter drugs need to be tested more thoroughly before being allowed on the market. “There’s a major public policy issue with respect to how over-the- counter products are regulated,” said Dr. Joshua Sharfstein, secretary of health and mental hygiene in Maryland and a former principal deputy commissioner of the F.D.A. Dr. Sharfstein was involved in 2007 in an effort to prohibit the use of certain cold medicines by infants and young children. Dr. Atkinson said his company discovered this effect in the course of developing a combination of PE, acetaminophen and ibuprofen. It found that levels of PE in the blood of people who took this combination were much higher than expected. Further testing showed that the effect was because of the acetaminophen, not the ibuprofen. He said it appeared that acetaminophen interfered with the breakdown of PE, allowing higher levels to build up in the blood. Still, the data for blood levels of PE shown in The New England Journal of Medicine website was for the triple combination. In its statement, the F.D.A. suggested the finding was irrelevant because the triple combination was not permitted to be sold in the United States. AFT is developing a combination product with half the usual dose of PE. It would benefit commercially if it could establish that the existing dose used in rival products raises safety issues. There is also controversy over whether PE is even effective. Leslie Hendeles, a professor of pharmacy and pediatrics at the University of Florida, said PE had only a minor effect at the dose used. Rather than raising safety concerns, he said, the finding that the effective dose of PE is increased in the combination medicines “would actually render what is an ineffective compound effective.” Source: New York Times, Andrew Pollack, 19 March 2014