ACID REDUCER (RANITIDINE) TABLET [WAL-MART STORES, INC]

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ACID REDUCER (RANITIDINE) TABLET [WAL-MART STORES, INC]
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NDC 49035-351-23
Set ID 72a73ed7-a269-4118-8e9c-f006d81a212b
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores, Inc
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 eating or drinking 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?

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-351-23

    equate®

    Compare to Maximum Strength Zantac 150® Tablets Active Ingredient*

    Maximum Strength

    Ranitidine Tablets, USP 150 mg

    Acid Reducer

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

    150 mg

    24 TABLETS

    Distributed by: Wal-Mart Stores, Inc.,

    5104622/ 0713

    newequaterani150

  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-351
    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
    ShapeOVALSize12mm
    FlavorImprint Code 9R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-351-231 in 1 CARTON
    124 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20053609/09/2013
    Labeler - Wal-Mart Stores, Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shasun Pharmaceuticals Limited915786829manufacture(49035-351)
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