Mucinex Tablet, Extended Release
FDA Label NDC 72854-223

Active ingredients
(in each extended-release tablet)

Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)

Pseudoephedrine HCl 120 mg,

Purposes
(in each extended-release tablet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*........Pain reliever/fever reducer

Pseudoephedrine HCl 120 mg,
extended-release..................................Nasal decongestant
*nonsteroidal anti-inflammatory drug

Uses
temporarily relieves these cold, sinus, and flu symptoms:
■ sinus pressure

■ minor body aches and pains
■ headache
■ nasal and sinus congestion (promotes sinus drainage
and restores freer breathing through the nose)
■ 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
■ 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.
■ in children under 12 years of age

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, thyroid disease,
diabetes, have trouble urinating due to an enlarged
prostate gland, or had a stroke
■ you are taking a diuretic
■ you have problems or serious side effects from taking
pain relievers or fever reducers

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

■ redness or swelling is present in the painful area
■ any new symptoms appear
■ fever gets worse or lasts more than 3 days
■ you have difficulty swallowing or the extended-release
tablet feels stuck in your throat
■ you get nervous, dizzy, or sleepless
■ nasal congestion lasts more than 7 days

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 take more than directed
■ the smallest effective dose should be used
■ swallow whole; do not crush or chew
■ drink a full glass of water with each dose
■ adults and children 12 years and older:
1 extended-release tablet every 12 hours; do not
take more than 2 extended-release tablets in 24 hours
■ children under 12 years: do not use

Other information
■ each extended-release tablet contains : sodium 21 mg
■ FDA approved dissolution specification differs from the
USP dissolution specification
■ store at 20-25°C (68-77°F)
■ store in a dry place

Inactive ingredients
colloidal silicon dioxide, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polysorbate 80, povidone,
talc, titanium dioxide

Questions? 1-866-MUCINEX (1-866-682-4639)