Mucinex 12hr Cold and Fever Multi-Symptom
30 mg + 110 mg + 600 mg · Tablet, Extended Release
- Available without prescription
- Expectorant
- Active substance
- Naproxen Sodium, Dextromethorphan Hydrobromide, Guaifenesin
- Used in
- Muscles, joints and bones
- Made by
- Reckitt Benckiser LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2026-06-02
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
- Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
All warnings ↓- Sold without a prescription
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
temporarily relieves:
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- 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
From the official label · 2026-06-02 · DailyMed
How to take it
These directions are for this exact strength and form. Another one is different.
- 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
Quoted from the official label, section “Dosage & Administration”.
Other 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.
Quoted from the official label, section “Warnings”.
Keep away from children
In case of overdose, get medical help or contact a Poison Control Center right away.
Quoted from the official label, section “OTC — Keep Out of Reach of Children”.
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)
Quoted from the official label, section “OTC — Other Information”.
What kind of medicine it is
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
Quoted from the official label, section “OTC — Purpose”.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
croscarmellose sodium, FD&C red no. 40, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium bicarbonate, sodium lauryl sulfate
Quoted from the official label, section “Inactive Ingredients”.
Questions about this product
1-866-MUCINEX (1-866-682-4639)
Quoted from the official label, section “OTC — Questions”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Colour dyes
FD&C red no. 40
Some people react to dyes such as tartrazine (Yellow 5) or carmine.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Details
| Made by | Reckitt Benckiser LLC |
|---|---|
| Active substance | Naproxen Sodium, Dextromethorphan Hydrobromide, Guaifenesin |
| Used in | Muscles, joints and bones |
| Strength | 30 mg + 110 mg + 600 mg |
| Form | Tablet, Extended Release |
| Route | Oral |
| Packs | 2 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK · 4 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| NDC | 72854-001 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).