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Major Ranitidine (Major Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE in 1 CARTON (0904-5832-51) > 50 TABLET in 1 BOTTLE Label Information
TABLET 3 BLISTER PACK in 1 CARTON (0904-5832-24) > 8 TABLET in 1 BLISTER PACK Label Information

Complete Major Ranitidine Information

  • Active ingredient (in each tablet)

    Ranitidine 150 mg (as ranitidine hydrochloride 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.
  • 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

    • store at 20°-25°C (68°-77°F)
    • avoid excessive heat or humidity
    • this product is sugar free

  • Inactive Ingredients

    colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD&C yellow # 6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.
  • Questions or comments?

    Call 1-800-753-3935 Monday- Friday 9AM- 5PM EST


  • Product Label

    Major®

    Maximum Strength Ranitidine Tablets, USP 150 mg

    Acid Reducer

    Prevents and relieves heartburn associated with acid indigestion and sour stomach

    Compare to the active ingredient of Zantac 150®*

    *This product is not manufactured by Boehringer Ingelheim Consumer Health care products, owner of the registered trademark Zantac 150®

    Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

    DO NOT USE IF PRINTED FOIL UNDER BOTTLE CAP IS OPEN OR TORN

    Distributed by

    major® pharmaceuticals

    31778 enterprise drive

    livonia MI 48150 USA

    Product of INDIA

    Ranitidine 50 count

    Major Ranitidine Tablets 150 mg


  • INGREDIENTS AND APPEARANCE
    MAJOR RANITIDINE  MAXIMUM STRENGTH
    ranitidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5832
    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)  
    DIETHYL PHTHALATE (UNII: UF064M00AF)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color ORANGE Score no score
    Shape HEXAGON (6 SIDED) Size 11mm
    Flavor Imprint Code W;741
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5832-24 3 in 1 CARTON
    1 8 in 1 BLISTER PACK
    2 NDC:0904-5832-51 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 ANDA078653 02/18/2008
    Labeler - Major Pharmaceuticals (191427277)