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naproxen sodium

Rite Aid Corporation

Rite Aid Corporation Naproxen Sodium Tablets, 220 mg Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

naproxen sodium 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

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
  • •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,

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.

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

Directions

  • •do not take more than directed
  • •the smallest effective dose should be used
  • •drink a full glass of water with each dose
take 1 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8- to 12-hour period
  • do not exceed 3 tablets in a 24-hour periodask a doctor

    Adults and

    children

    12 years

    and older

    Children

    under 12

    years

    naproxen sodium Other information

    • •each tablet contains: sodium 21 mg
    • •store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

    Inactive ingredients

    FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

    Questions or comments?

    1-800-719-9260

    Principal Display Panel

    Compare to the active ingredient of Aleve® Tablets

    pain reliever/fever reducer

    naproxen sodium tablets, 220 mg

    pain reliever/fever reducer (NSAID)

    strength to last 12 hours

    actual size

    naproxen sodium

    Naproxen Sodium TABLET

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:11822-0490
    Route of Administration ORAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    naproxen sodium NAPROXEN 220 mg

    Inactive Ingredients

    Ingredient Name Strength
    HYPROMELLOSES
    MAGNESIUM STEARATE
    cellulose, microcrystalline
    POLYETHYLENE GLYCOLS
    POVIDONES
    talc
    titanium dioxide

    Product Characteristics

    Color Size Imprint Code Shape
    BLUE (Light Blue) 10 mm L490 ROUND

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 50 in 1 BOTTLE
    2 100 in 1 BOTTLE
    3 NDC:11822-0490-7 1 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074661 2001-05-16


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    Be sure to consult your doctor before taking any medication!
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