Label: MAXIMUM STRENGTH HEARTBURN RELIEF- ranitidine hydrochloride tablet 

  • Label RSS
  • NDC Code(s): 33992-0620-1
  • Packager: GREENBRIER INTERNATIONAL, 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 03/14

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 wheeing, 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.
    • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
    • heartburn with lightheadedness, sweating, or dizziness 

    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 INDIVIDUAL BLISTER UNIT 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, hyrpomellose, 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

    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

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

    Assured 44-620

    Assured 44-620

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  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH HEARTBURN RELIEF 
    ranitidine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-0620
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    MAGNESIUM STEARATE  
    TALC  
    TITANIUM DIOXIDE  
    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
    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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