NAPROXEN (NAPROXEN SODIUM) TABLET [MEDLINE INDUSTRIES, INC.]

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NAPROXEN (NAPROXEN SODIUM) TABLET [MEDLINE INDUSTRIES, INC.]
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NDC 53329-675-30
Set ID 1ffd186b-7380-4e17-919e-2352d112bd30
Category HUMAN OTC DRUG LABEL
Packager Medline Industries, Inc.
Generic Name
Product Class
Product Number
Application Number NDA020204
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)1

    1
    nonsteroidal anti-inflammatory drug
  • Purposes

    Pain reliever/fever reducer

  • Uses

    •
    temporarily relieves minor aches and pains due to:
    •
    headache
    •
    minor pain of arthritis
    •
    backache
    •
    menstrual cramps
    •
    muscular aches
    •
    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 have problems or serious side effects from taking pain relievers or fever reducers
    •
    you have asthma
    •
    you are taking a diuretic

    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.

  • 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 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
  • Other information

    •
    each tablet contains: sodium 20 mg
    •
    store at room temperature. Avoid excessive heat above 40°C (104°F).
    •
    read all warnings and directions before use. Keep carton
  • Inactive ingredients

    FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

    Call toll free 1-800-MEDLINE (633-5463) Monday-Friday 9am-5pm cst)

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    Medline Industries, Inc.

    Mundelein, IL 60060

  • PRINCIPAL DISPLAY PANEL – 100 Tablet Bottle Carton

    Medline

    NDC53329-675-30

    **Compare to the active ingredient in Aleve

    Naproxen

    Pain Reliever/

    Fever Reducer (NSAID)

    Strength to last 12 Hours

    Naproxen Sodium Tablets

    220 mg

    100 Tablets – 220 mg each

    PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NAPROXEN 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-675
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (light blue) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code ALEVE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-675-301 in 1 CARTON
    1100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020407/26/2002
    Labeler - Medline Industries, Inc. (025460908)
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