Label: RANITIDINE- ranitidine hydrochloride tablet, film coated

  • NDC Code(s): 49035-353-30, 49035-353-55, 49035-353-69
  • Packager: Wal-Mart Stores, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/15

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 mg)

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  • PURPOSE

    Acid reducer

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  • 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
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  • 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

    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).

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  • 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
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  • 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
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  • INACTIVE INGREDIENTS

    Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide

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  • QUESTIONS?

    Call 1-888-287-1915

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  • PRINCIPAL DISPLAY PANEL

    NDC 49035-353-30

    equate

    Compare to Zantac 75®Active Ingredient*

    Regular Strength

    Ranitidine Tablets, 75 mg

    Acid Reducer

    Prevents and Relieves Heartburn associated with acid indigestion and sour stomach

    75 mg

    30 TABLETS

    Distributed by: Wal-Mart Stores, Inc.,

    5114573 12/14

    This is the 30 count blister carton label for Walmart Ranitidine tablets, 75 mg.
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  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-353
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 75 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color pink Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code OR;606
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-353-55 150 in 1 BOTTLE; Combination Product Type = C112160
    2 NDC:49035-353-69 10 in 1 BLISTER PACK; Combination Product Type = C112160
    3 NDC:49035-353-30 30 in 1 BOTTLE; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA201745 07/10/2012
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Ranbaxy Pharmaceuticals Inc. (184769029)
    Establishment
    Name Address ID/FEI Business Operations
    Shasun Pharmaceuticals Limited 915786829 MANUFACTURE(49035-353)
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