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Ranitidine (Chain Drug Marketing Association Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 24 TABLET in 1 BLISTER PACK (63868-487-24) Label Information
TABLET 50 TABLET in 1 BOTTLE (63868-487-50) Label Information

Complete Ranitidine Information

  • 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

    QC QUALITY CHOICE®

    NDC 63868-0487-50

    †Compare to the active ingredient in Zantac 150®

    MAXIMUM STRENGTH

    HEARTBURN

    150 RANITIDINE TABLETS, USP 150 mg

    ACID REDUCER

    Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

    50 Tablets

    ©DISTRIBUTED BY QUALITY CHOICE

    5093011/0112

    This is the 50 count bottle carton label for Quality Choice Ranitidine tablets, USP 150 mg.

  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    ranitidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-487
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 150 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color pink Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code 9R
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63868-487-24 24 in 1 CARTON
    1 1 in 1 BLISTER PACK
    2 NDC:63868-487-50 1 in 1 CARTON
    2 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA200536 03/30/2012
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Establishment
    Name Address ID/FEI Business Operations
    Shasun Pharmaceuticals Limited 915786829 manufacture(63868-487)