Quick answers
- What is Dextromethorphan, guaifenesin and naproxen used for?
- The Drug Facts label of Mucinex 12HR Cold and Fever Multi-Symptom (Reckitt Benckiser LLC) lists these uses: helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive; temporarily relieves; cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants; the intensity of coughing; the impulse to cough to help you get to sleep; minor aches and pains due to headache and the common cold; temporarily reduces fever.
- Do I need a prescription for Dextromethorphan, guaifenesin and naproxen?
- No. The products on this page are sold without a prescription (over the counter).
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Dextromethorphan, guaifenesin and naproxen been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Mucinex 12HR Cold and Fever Multi-Symptom · Reckitt Benckiser LLC
Dextromethorphan hydrobromide 30 mg · Guaifenesin 600 mg · Naproxen sodium 110 mg, tablet, extended release (oral)
Active ingredient (in each extended-release tablet)
Dextromethorphan HBr 30 mg Guaifenesin 600 mg Naproxen sodium 110 mg (naproxen 100 mg) (NSAID*) *nonsteroidal anti-inflammatory drug
Purpose
Active ingredients (in each extended-release tablet) >> Purposes Dextromethorphan HBr 30 mg >> Cough Suppressant Guaifenesin 600 mg >> Expectorant Naproxen Sodium 110 mg (NSAID*) >> Pain Reliever/Fever Reducer *nonsteroidal anti-inflammatory drug
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- minor aches and pains due to headache and the common cold
- temporarily reduces fever
Warnings
Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters If an allergic reaction occurs, stop use and seek medical help right away.
- Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- for children under 12 years of age
- right before or after heart surgery
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- you have a cough accompanied by too much phlegm (mucus)
Ask a doctor or pharmacist before use if
you are
- under a doctor’s care for any serious condition
- taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing
- it feels like the pill is stuck in your throat
- redness or swelling is present in the painful area
- any new symptoms appear
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
If pregnant or breast-feeding
ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not crush, chew, or break extended-release tablet
- do not take more than directed
- take each dose with a full glass of water
- adults and children 12 years and older: take 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
- children under 12 years of age: do not use
Other information
- each extended-release tablet contains: sodium 26 mg
- store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F)
Inactive ingredients
croscarmellose sodium, FD&C red no. 40, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium bicarbonate, sodium lauryl sulfate
Questions?
1-866-MUCINEX (1-866-682-4639)
— FDA label of Mucinex 12HR Cold and Fever Multi-Symptom, Reckitt Benckiser LLC, effective June 2, 2026. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Dextromethorphan hydrobromide 30 mg · Guaifenesin 600 mg · Naproxen sodium 110 mg · tablet, extended release (oral) · 1 product
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Mucinex 12HR Cold and Fever Multi-Symptom | Reckitt Benckiser LLC | DailyMed |
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Reckitt Benckiser LLC1 product
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.