Mucinex Tablet, Extended Release
FDA Label NDC 72854-001

Drug Facts

Active ingredients (in each extended-release tablet)
Dextromethorphan HBr 30 mg
Guaifenesin 600 mg
Naproxen sodium 110 mg (naproxen 100 mg) (NSAID*)
*nonsteroidal anti-inflammatory drug

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)

NDC 72854-001-16

Mucinex®

12HR COLD & FEVER

MULTI-SYMPTOM

Naproxen Sodium 110 mg (NSAID) >> Pain Reliever/Fever Reducer

Dextromethorphan HBr 30 mg >> Cough Suppressant

Guaifenesin 600 mg >> Expectorant

Extended-Release Tablets

12 HOUR

Fever, Headache & Body Pain
Cough + Chest Congestion
Thins & Loosens Mucus

16 EXTENDED-RELEASE TABLET