Home > Drugs A-Z > NAPROXEN SODIUM

NAPROXEN SODIUM (SPIRIT PHARMACEUTICALS,LLC)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED, EXTENDED RELEASE 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68210-0400-0) Label Information

Complete NAPROXEN SODIUM Information

  • Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purpose
    *
    • Nonsteroidal anti-inflammatory drug
    Naproxen Sodium 220 mg Pain reliever
    (Naproxen Sodium 200mg) (NSAID) * Fever reducer

  • Uses

    • 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

    Allergy alert

    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.

    Stomach bleeding warning

    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

    Heart attack and stroke warning 

    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.

    Do not use
    • if you have ever had an allergic reaction to any other pain reliever / fever reducer
    • right before or after surgery

    Ask a doctor before use if
    • 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

    Ask a doctor or pharmacist before use if you are
    • under a doctor 's care for any serious conditions
    • 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 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)


  • Direction

    *Do not take more than as 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 table every 8 to 12 hours while symptoms last
    - for the first dose you may have 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 any 24 hour period
    *Children under 12 years - ask a doctor


  • Other information

    • 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)

  • Inactive ingredients

    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


  • SPL UNCLASSIFIED SECTION

    Distributed By: Greenbrier International, Inc. Chesapeake, VA 23320


  • PRINCIPAL DISPLAY PANEL - 220 mg Bottle Carton

    ASSUR XED â„¢

    SEE NEW WARNINGS INFORMATION

    Compare to the active
    ingredient in Aleve®*

    ALL DAY
    PAIN RELIEF

    NAPROXEN SODIUM TABLETS, USP 220 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    • STRENGTH TO LAST 12 HOURS

    15 TABLETS (OVAL-SHAPED)

    image description


  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0400
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONES (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Color blue Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code 144
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68210-0400-0 1 in 1 CARTON 12/22/2017
    1 15 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:68210-0400-1 1 in 1 CARTON 11/22/2017
    2 50 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090545 11/22/2017
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
    Establishment
    Name Address ID/FEI Business Operations
    Marksans Pharma Ltd 925822975 manufacture(68210-0400)