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Maximum Strength Zantac (Boehringer Ingelheim Pharmaceuticals Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 80 POUCH in 1 CARTON (0597-0121-82) > 1 TABLET, COATED in 1 POUCH Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (0597-0121-94) > 45 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 2 BOTTLE in 1 CARTON (0597-0121-90) > 45 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (0597-0121-85) > 85 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (0597-0121-68) > 65 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BLISTER PACK in 1 CARTON (0597-0121-38) > 8 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 1 TABLET, COATED in 1 POUCH (0597-0121-08) Label Information
TABLET, COATED 4 BLISTER PACK in 1 CARTON (0597-0121-09) > 8 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 80 POUCH in 1 CARTON (0597-0121-80) > 1 TABLET, COATED in 1 POUCH Label Information
TABLET, COATED 3 BLISTER PACK in 1 CARTON (0597-0121-24) > 8 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (0597-0121-50) > 50 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BLISTER PACK in 1 CARTON (0597-0121-06) > 3 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (0597-0121-64) > 65 TABLET, COATED in 1 BOTTLE Label Information

Complete Maximum Strength Zantac Information

  • Drug Facts

    Active ingredient (in each tablet) Purpose
    Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)...................................................................................................... Acid reducer

  • 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

  • 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

    • 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
    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • unexplained weight loss
    • nausea or vomiting
    • stomach pain

  • 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

    • do not use if printed foil under bottle cap is open or torn (bottles)
    • do not use if individual blister unit is open or torn (blisters)
    • do not use if individual foil packet is open or torn (pouch)
    • store at 20º-25ºC (68º-77ºF)
    • avoid excessive heat or humidity
    • this product is sodium and sugar free

  • Inactive ingredients

    hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin


  • Questions?

    Call 1-888-285-9159 (English/Spanish) M – F, 8:30 – 5 EST, or visit www.zantacotc.com

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

    Boehringer Ingelheim Consumer Health Care Products
    Division of Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
    Copyright © 2015, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.
    Product of Spain. Manufactured in Mexico.


  • PRINCIPAL DISPLAY PANEL

    Zantac 150 mg - 24 Count Blister Carton

    Zantac 150 24 Count Blister Carton

  • PRINCIPAL DISPLAY PANEL

    Zantac 150 mg - 65 Count Bottle Carton

    Zantac 150 65 Count Bottle Carton

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH ZANTAC 
    ranitidine tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0597-0121
    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
    hypromelloses (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    triacetin (UNII: XHX3C3X673)  
    Product Characteristics
    Color PINK (Dark Pink) Score no score
    Shape PENTAGON (5 sided) Size 4mm
    Flavor Imprint Code Z;150
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0597-0121-06 1 in 1 CARTON
    1 3 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0597-0121-50 1 in 1 CARTON
    2 50 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0597-0121-08 1 in 1 POUCH; Type 0: Not a Combination Product
    4 NDC:0597-0121-09 4 in 1 CARTON
    4 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:0597-0121-24 3 in 1 CARTON
    5 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6 NDC:0597-0121-38 1 in 1 CARTON
    6 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7 NDC:0597-0121-64 1 in 1 CARTON
    7 65 in 1 BOTTLE; Type 0: Not a Combination Product
    8 NDC:0597-0121-68 1 in 1 CARTON
    8 65 in 1 BOTTLE; Type 0: Not a Combination Product
    9 NDC:0597-0121-80 80 in 1 CARTON
    9 1 in 1 POUCH; Type 0: Not a Combination Product
    10 NDC:0597-0121-82 80 in 1 CARTON
    10 1 in 1 POUCH; Type 0: Not a Combination Product
    11 NDC:0597-0121-94 1 in 1 CARTON
    11 45 in 1 BOTTLE; Type 0: Not a Combination Product
    12 NDC:0597-0121-90 2 in 1 CARTON
    12 45 in 1 BOTTLE; Type 0: Not a Combination Product
    13 NDC:0597-0121-85 1 in 1 CARTON
    13 85 in 1 BOTTLE; Type 0: Not a Combination Product
    14 NDC:0597-0121-01 2 in 1 CARTON
    14 50 in 1 BOTTLE; Type 0: Not a Combination Product
    15 NDC:0597-0121-78 1 in 1 CARTON
    15 78 in 1 BOTTLE; Type 0: Not a Combination Product
    16 NDC:0597-0121-66 1 in 1 CARTON
    16 40 in 1 BOTTLE; Type 0: Not a Combination Product
    17 NDC:0597-0121-11 2 in 1 CARTON
    17 60 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021698 12/21/2006
    Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
    Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
    Establishment
    Name Address ID/FEI Business Operations
    Patheon Manufacturing Services LLC 079415560 MANUFACTURE(0597-0121)
    Establishment
    Name Address ID/FEI Business Operations
    Boehringer Ingelheim Promeco S.A de C.V. 812579472 PACK(0597-0121) , ANALYSIS(0597-0121) , LABEL(0597-0121) , MANUFACTURE(0597-0121)