FDA Approves Mucinex 12HR Cold & Fever Multi-Symptom for Cold and Flu Relief

What Is Mucinex 12HR Cold & Fever Multi-Symptom, and How Does It Work?

The FDA has approved Mucinex 12HR Cold & Fever Multi-Symptom.It is an over-the-counter medicine used to relieve symptoms of the common cold or the flu.These symptoms include a fever, headache, body aches, coughing, and chest congestion.This medicine contains three active ingredients: guaifenesin, dextromethorphan hydrobromide, and naproxen sodium.

Guaifenesin is an expectorant that thins and loosens mucus in the chest to make coughs more productive.

Dextromethorphan hydrobromide is a cough suppressant, which helps reduce the urge to cough. Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) that reduces fever and relieves pain. The medicine comes in a two-layer tablet. The tablet releases active ingredients quickly and over time to provide relief for up to 12 hours.

Why Was It Approved?

The FDA approved Mucinex 12HR Cold & Fever Multi-Symptom after reviewing scientific research and clinical evaluation submitted by the drugmaker. It combines an expectorant, a cough suppressant, and an NSAID pain reliever into a single extended-release tablet. Cold and flu symptoms are largely caused by the body’s inflammatory response to an infection. By adding naproxen sodium to cough and congestion ingredients, the tablet treats inflammation, fever, and mucus at the same time. This design allows people to manage multiple symptoms with extended relief rather than taking shorter-acting medicines repeatedly throughout the day.

What Do I Need to Know?

Mucinex 12HR Cold & Fever Multi-Symptom is taken by mouth with a full glass of water. The extended-release tablets must be swallowed whole. Do not crush, chew, or break the tablets. If you get an upset stomach, take the medicine with food or milk. This drug should not be used in children under 12 years of age. Because naproxen sodium is an NSAID, this medication carries safety warnings for severe allergic reactions, stomach bleeding, heart attack, and stroke. The risk of stomach bleeding is higher in people age 60 or older, those with past stomach ulcers, or those taking blood thinners, steroids, or other NSAID medications. Do not use this product if you are currently taking a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the last 14 days.

Ask a health care provider before use if you have high blood pressure, heart disease, kidney disease, liver cirrhosis, asthma, or a history of stomach problems. If you are pregnant or breastfeeding, speak with a health care provider before taking this drug. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless specifically directed by a health care provider, as it may cause issues for the fetus or delivery complications. Stop taking the medicine and seek emergency medical care right away if you have signs of an allergic reaction, signs of stomach bleeding (such as feeling faint, vomiting blood, or black stools), or symptoms of heart problems or stroke (such as chest pain, trouble breathing, or weakness on one side of the body). Contact a health care provider if pain or coughing gets worse, if a fever lasts more than three days, or if a cough lasts more than seven days.