Label: NAPROXEN SODIUM- naproxen sodium tablet, coated 

  • Label RSS
  • NDC Code(s): 57344-144-01, 57344-144-02, 57344-144-03, 57344-144-04, view more
    57344-144-05, 57344-144-06, 57344-144-07, 57344-144-08, 57344-144-10, 57344-144-11
  • Packager: AAA Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID1)


    1
    nonsteroidal anti-inflammatory drug
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  • Purpose

    Pain reliever/fever reducer

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  • 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
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  • 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

    • 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 asthma
    • 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 any other drug

    When using this product

    • take with food or milk if stomach upset occurs
    • long term continuous use may increase the risk of heart attack or stroke

    Stop use and ask a doctor if

    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    • 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
    • you develop heartburn
    • 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.

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  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)
    • drink a full glass of water with each dose
    adults and children 12 years and older
    • 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 period
    children under 12 years
    • ask a doctor
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  • Other information

    • each tablet contains: sodium 20 mg
    • store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
    • retain carton for complete product information
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  • Inactive ingredients

    croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

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  • PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton

    RESTORE u

    NDC 57344-144-01

    COMPARE TO THE ACTIVE
    INGREDIENT IN ALEVE®

    Naproxen
    Naproxen Sodium Tablets, 220 mg

    Pain Reliever / Fever Reducer
    (NSAID)

    24 COATED TABLETS

    PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57344-144
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    FD&C BLUE NO. 2  
    POLYETHYLENE GLYCOLS  
    MAGNESIUM STEARATE  
    POLYVINYL ALCOHOL  
    POVIDONES  
    STARCH, CORN  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code I3
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-144-01 1 in 1 CARTON
    1 24 in 1 BOTTLE, PLASTIC
    2 NDC:57344-144-02 1 in 1 CARTON
    2 50 in 1 BOTTLE, PLASTIC
    3 NDC:57344-144-03 1 in 1 CARTON
    3 100 in 1 BOTTLE, PLASTIC
    4 NDC:57344-144-04 1 in 1 CARTON
    4 150 in 1 BOTTLE, PLASTIC
    5 NDC:57344-144-05 1 in 1 CARTON
    5 200 in 1 BOTTLE, PLASTIC
    6 NDC:57344-144-06 1 in 1 CARTON
    6 300 in 1 BOTTLE, PLASTIC
    7 NDC:57344-144-07 500 in 1 BOTTLE, PLASTIC
    8 NDC:57344-144-08 200 in 1 BOTTLE, PLASTIC
    9 NDC:57344-144-10 400 in 1 BOTTLE, PLASTIC
    10 NDC:57344-144-11 600 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079096 12/15/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
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