The US Food and Drug Administration has approved Mucinex 12HR Cold & Fever Multi-Symptom, an over-the-counter extended-release product for cold and flu symptom relief, according to an announcement from Reckitt.
Reckitt described the approval as the first FDA-approved OTC innovation in the cold and flu category in 14 years and the company’s first New Drug Application approval under the Reckitt name. The product is now available at retailers nationwide.
Mucinex 12HR Cold & Fever Multi-Symptom combines 3 active ingredients in a bilayer extended-release tablet: guaifenesin 600 mg, an expectorant; dextromethorphan HBr 30 mg, a cough suppressant; and naproxen sodium 110 mg, equivalent to naproxen 100 mg, a nonsteroidal anti-inflammatory drug used for pain relief and fever reduction.
- Drug: Mucinex 12HR Cold & Fever Multi-Symptom
- Class: NSAID/expectorant/cough suppressant combo
- Active ingredients: Guaifenesin, dextromethorphan HBr, naproxen sodium
- Indication: Fever, cough, chest congestion, body pain
- Formulation: Bilayer extended-release tablet, OTC
- Regulatory action: FDA NDA approval, 2026
- First OTC cold/flu NDA approval in ~14 years
- Duration claim: Up to 12 hours per dose
- Key safety note: Contains NSAID; use caution in at-risk patients
- Geography: United States; available at retail nationwide
What symptoms does Mucinex 12HR Cold & Fever Multi-Symptom treat?
Mucinex 12HR Cold & Fever Multi-Symptom helps loosen phlegm and thin bronchial secretions to make coughs more productive. It also temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, reduces the intensity and impulse to cough, relieves minor aches and pains due to headache and the common cold, and temporarily reduces fever.
It is the first and only FDA-approved OTC cold and flu medication that treats fever, cough, chest congestion, and body pain for 12 hours. The company also said the bilayer tablet provides immediate and extended release of active ingredients.
“True innovation starts with understanding consumer needs and applying science to solve them,” Angela Naef, PhD, chief research and development officer at Reckitt, said in the announcement. “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.”
How is the product used?
The product is indicated for adults and children aged 12 years and older. The labeled dosage is 2 extended-release tablets every 12 hours, taken with a full glass of water. Patients should not take more than 4 extended-release tablets in 24 hours and should not crush, chew, or break the tablets.
The product should not be used in children younger than 12 years.
What should primary care clinicians know?
For primary care clinicians, the approval is relevant because OTC cold and flu products are often used as first-line self-care, and patients may combine multiple products without recognizing overlapping ingredients or safety risks. This product contains naproxen sodium, so counseling should include attention to NSAID-related contraindications and warnings.
The label warns that naproxen sodium may cause severe allergic reactions, particularly in people allergic to aspirin. It also includes warnings for stomach bleeding and for heart attack, heart failure, and stroke risk associated with NSAID use. Risk of stomach bleeding is higher in adults aged 60 years and older; those with a history of stomach ulcers or bleeding problems; those taking anticoagulants, steroid drugs, or other NSAIDs; those who consume 3 or more alcoholic drinks daily while using the product; and those who take more than directed or use it longer than directed.
The product should not be used by patients who have ever had an allergic reaction to any other pain reliever or fever reducer, immediately before or after heart surgery, or while taking a prescription monoamine oxidase inhibitor or within 2 weeks after stopping one.
Patients should ask a clinician before use if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, prior stroke, persistent or chronic cough, cough with excessive phlegm, or are taking a diuretic, aspirin for cardioprotection, or other medications. The label notes that naproxen may decrease the cardioprotective benefit of aspirin.
Patients should stop use and seek medical advice if fever worsens or lasts more than 3 days, cough lasts more than 7 days or returns, pain worsens or lasts more than 10 days, new symptoms appear, or symptoms suggest stomach bleeding, heart problems, or stroke. Pregnant or breastfeeding patients should ask a health professional before use, and the label states that naproxen sodium should not be used at 20 weeks or later in pregnancy unless directed by a physician.
References
- Reckitt. Reckitt announces U.S. FDA approval of Mucinex 12HR Cold & Fever Multi-Symptom, the first OTC innovation in the cold & flu category in 14 years. Published August 5, 2026. Accessed August 5, 2026. https://www.reckitt.com/us/news/reckitt-announces-us-fda-approval-of-mucinex-12hr-cold-fever-multi-symptom-the-first-otc-innovation-in-the-cold-flu-category-in-14-years/
- DailyMed. Mucinex 12HR Cold and Fever Multi-Symptom—naproxen sodium, dextromethorphan hydrobromide, guaifenesin tablet, extended release. Updated June 2, 2026.
