WAL-ZAN (RANITIDINE) TABLET [WALGREEN COMPANY]

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WAL-ZAN (RANITIDINE) TABLET [WALGREEN COMPANY]
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NDC 0363-0362-02, 0363-0362-23, 0363-0362-50, 0363-0362-52, 0363-0362-95
Set ID 80536bce-8c34-4bb4-89c8-5e2700a27ce5
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number ANDA200536
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  • ACTIVE INGREDIENT (IN EACH TABLET)

    Ranitidine 150 mg (as ranitidine hydrochloride, USP 168 mg)

  • PURPOSE

    Acid reducer

  • USES

    •
    relieves heartburn associated with acid indigestion and sour stomach
    •
    prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages
  • WARNINGS

    Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

    Do Not Use

    •
    if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor
    •
    with other acid reducers
    •
    if you have kidney disease, except under the advice and supervision of a doctor

    Ask a doctor before use if you have

    •
    frequent chest pain
    •
    frequent wheezing, particularly with heartburn
    •
    unexplained weight loss
    •
    nausea or vomiting
    •
    stomach pain
    •
    had heartburn over 3 months. This may be a sign of a more serious condition.
    •
    heartburn with lightheadedness, sweating or dizziness
    •
    chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

    Stop use and ask a doctor if

    •
    your heartburn continues or worsens
    •
    you need to take this product for more than 14 days

    If pregnant or breast-feeding

    ask a health professional before use.

    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

    •
    adults and children 12 years and over:
    •
    to relieve symptoms, swallow 1 tablet with a glass of water
    •
    to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
    •
    can be used up to twice daily (do not take more than 2 tablets in 24 hours)
    •
    children under 12 years: ask a doctor
  • OTHER INFORMATION

    •
    TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.
    •
    store at 20° - 25° C (68° - 77° F)
    •
    avoid excessive heat or humidity
    •
    this product is sodium and sugar free
  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

  • QUESTIONS?

    call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    Well at Walgreens

    WALGREENS PHARMACIST RECOMMENDED*

    NDC 0363-0362-02

    MAXIMUM STRENGTH

    Wal-Zan® 150

    Ranitidine Tablets, USP 150 mg/Acid Reducer

    •
    Prevents & relieves heartburn associated with acid indigestion & sour stomach

    200 TABLETS

    Compare to Zantac 150® active ingredient‡‡

    DISTRIBUTED BY: WALGREEN CO.

    5114247/ORG115-F

    Walzanlabel200's
  • INGREDIENTS AND APPEARANCE
    WAL-ZAN 
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0362
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVAL (Oval, Shaped) Size12mm
    FlavorImprint Code 9R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0362-231 in 1 CARTON
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-0362-501 in 1 CARTON
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-0362-951 in 1 CARTON
    395 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-0362-521 in 1 BOTTLE
    465 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0363-0362-021 in 1 CARTON
    5200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20053606/28/2011
    Labeler - Walgreen Company (008965063)
    Registrant - Ranbaxy Pharmaceuticals Inc (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shasun Pharmaceuticals Limited915786829MANUFACTURE(0363-0362)
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