Label: RANITIDINE- ranitidine hydrochloride tablet, film coated

  • 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 08/13

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 1-800-406-7984

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  • PRINCIPAL DISPLAY PANEL

    sunmark®

    *COMPARE TO ZANTAC 75® ACTIVE INGREDIENT

    NDC 49348-473-12

    Ranitidine Tablets, USP 75 mg

    acid reducer

    Prevents and Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

    Regular Strength

    60 TABLETS

    Distributed By McKesson

    5104148/0713

    60's bottle carton label

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  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-473
    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
    COLLOIDAL 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:49348-473-12 1 in 1 CARTON
    1 60 in 1 BOTTLE
    2 NDC:49348-473-44 1 in 1 CARTON
    2 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA201745 09/20/2013
    Labeler - Sunmark (177667227)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Shasun Pharmaceuticals Limited 915786829 manufacture(49348-473)
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