Naproxen Sodium Tablet, Film Coated, Extended Release
FDA Label NDC 68210-4096

Drug Facts

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Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/

fever reducer

• temporarily relieves minor aches and pain due to :
• backache
• headache
• menstrul cramps
• minor pain of arthritis
• muscular aches
• the common cold
• toothache
• temporarily reduces fever

Warnings

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• asthma (wheezing)
• blisters
• facial swelling
• hives
• rash
• shock
• skin reddening

If an allergic reaction occurs, stop use and seek medical help right away.

This product contains a non steroidal anti-inflammatory drug(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

NSAID's except aspirin increases 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.

• if you have ever had an allergic reaction to any other pain reliever / fever reducer
• right before or after surgery

• the stomach bleeding warning applies to you
• you have a history of stomach problems,such as a heartburn
• you have a high blood pressure, heart disease, liver cirrhosis or kidney disease
• you are taking a diuretic
• you have problems or serious side effects taking pain relievers or fever reducers
• you have asthma

• under a doctor 's care for any serious conditions
• taking any other drug

• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

• you experience any of following sign of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• you have difficulty swallowing
• it feel like the pill is stuck in your throat
• redness or swelling is present in the painful area
• any new symptoms appear

If pregnant or breast feeding, ask a health profession before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complication during the delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a position control center right away (1-800-222-1222)

• each tablet contains: sodium 20 mg
• store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)

Colloidal silicon dioxide*, croscarmellose sodium*, FD&C Blue#2 lake, hypromellose, magnesium stearate*, maize starch*, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate*, stearic acid*, titanium dioxide.

*contains one or more of these ingredients

CABINET

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)