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FDA LABEL GENERIC: Naproxen MFR: Command Brands, LLC

Naproxen Sodium 220 Mg (as Naproxen 200 Mg) Oral Tablet

Active ingredient

Naproxen sodium 220mg

(naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

minor pain of arthritis muscular aches backache menstrual cramps headache toothache 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 right before or after heart surgery

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, or kidney disease you are taking  a diuretic you have  problems or serious side effects from taking pain relievers or fever reducers you have asthma

Ask a doctor or pharmacist before use if you are

under a doctor’s care for any serious condition taking any other drug

When using this product

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

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

If pregnant or breast-feeding,

If pregnant or breast-feeding, ask a health professional 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 complications during delivery.

Keep out of reach of children

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

Directions

do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose Adults and children 12 years and older: take 1 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8 to 12 hour period do not exceed 3 caplets in a 24 hour period  Children under 12 years: ask a doctor

Other information

each caplet contains: sodium 20 mg store at 20-25°C (68-77° F) avoid high humidity and excessive heat above 40° C (104° F) do not use if tamper evident seal under bottle is broken or missing

Inactive ingredients

FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

May contain: corn starch, croscarmellose sodium, magnesium stearate, purified water, silicon dioxide, sodium starch glycolate, stearic acid  

Questions or Comments?

Call1-888-952-0050

Monday through Friday 9AM-5PM EST.

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