Label: HEARTBURN RELIEF MAXIMUM STRENGTH- ranitidine hydrochloride tablet, film coated

  • NDC Code(s): 33992-0620-1
  • Packager: GREENBRIER INTERNATIONAL, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 04/15

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

  • Active ingredient (in each tablet)

    Ranitidine 150 mg
    (as ranitidine hydrochloride USP, 168 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 certain foods and beverages
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  • Warnings

    Allergy alert: Do not use if you are allergic to ranitidine or any 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 (1-800-222-1222) right away. 

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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 20º-25ºC (68º-77ºF)
    • avoid excessive heat or humidity
    • this product is sodium and sugar free
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

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

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  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

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  • Principal display panel

    ASSUREDâ„¢

    COMPARE TO ACTIVE INGREDIENT OF MAXIMUM STRENGTH ZANTAC 150®*

    MAXIMUM STRENGTH
    HEARTBURN
    RELIEF
    • Ranitidine 150 mg
    - Acid Reducer

    Relieves and prevents heartburn due to acid indigestion

    30 tablets

    TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN

    DOES NOT CONTAIN GLUTEN
    *This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Zantac 150®.
    50844    ORG031362001
    Product of India

    ITEM #200907
    Distributed by: Greenbrier International, Inc.
    Chesapeake, VA 23320 USA

    Assured 44-620

    Assured 44-620

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  • INGREDIENTS AND APPEARANCE
    HEARTBURN RELIEF  MAXIMUM STRENGTH
    ranitidine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0620
    Route of Administration ORAL DEA Schedule     
    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)  
    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:33992-0620-1 1 in 1 CARTON
    1 30 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA200536 06/15/2013
    Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
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