NAPROXEN SODIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]

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NAPROXEN SODIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]
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NDC 71335-1061-1, 71335-1061-2, 71335-1061-3, 71335-1061-4, 71335-1061-5, 71335-1061-6, 71335-1061-7, 71335-1061-8
Set ID 3d57ba5c-3a1d-435a-aa4f-9cc709e1b8cf
Category HUMAN OTC DRUG LABEL
Packager Bryant Ranch Prepack
Generic Name
Product Class
Product Number
Application Number ANDA074661
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  • Active ingredient (in each tablet)

    Naproxen sodium 220 mg

    (naproxen 200 mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purposes

    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, kidney disease, asthma, or had a stroke
    •
    you are taking a diuretic
    •
    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

    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,

    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

    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 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

  • HOW SUPPLIED

    Product: 71335-1061

    NDC: 71335-1061-1 20 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1061-2 30 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1061-3 40 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1061-4 50 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1061-5 60 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1061-6 14 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1061-7 100 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1061-8 90 TABLET, FILM COATED in a BOTTLE

  • Naproxen Sodium 220mg Tablet

    Label Image
  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1061(NDC:45802-490)
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (Light Blue) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code L490
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1061-120 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
    2NDC:71335-1061-230 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
    3NDC:71335-1061-340 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
    4NDC:71335-1061-450 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
    5NDC:71335-1061-560 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
    6NDC:71335-1061-614 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
    7NDC:71335-1061-7100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
    8NDC:71335-1061-890 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07466104/11/2014
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1061) , RELABEL(71335-1061)
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