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Zantac 75 (Boehringer Ingelheim Pharmaceuticals Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 4 BLISTER PACK in 1 CARTON (0597-0122-40) > 10 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 100 POUCH in 1 CARTON (0597-0122-61) > 1 TABLET, COATED in 1 POUCH Label Information
TABLET, COATED 1 BLISTER PACK in 1 CARTON (0597-0122-34) > 4 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 100 POUCH in 1 CARTON (0597-0122-57) > 1 TABLET, COATED in 1 POUCH Label Information
TABLET, COATED 3 BLISTER PACK in 1 CARTON (0597-0122-37) > 10 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (0597-0122-54) > 60 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (0597-0122-92) > 105 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 TABLET, COATED in 1 POUCH (0597-0122-08) Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (0597-0122-81) > 80 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 2 BLISTER PACK in 1 CARTON (0597-0122-27) > 10 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 1 BLISTER PACK in 1 CARTON (0597-0122-13) > 10 TABLET, COATED in 1 BLISTER PACK Label Information

Complete Zantac 75 Information

  • Drug Facts

    Active ingredient (in each tablet) Purpose
    Ranitidine 75 mg (as ranitidine hydrochloride 84 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

  • 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

    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)
      • do not chew tablet
    • 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 20-25ºC (68-77ºF)
    • avoid excessive heat or humidity
    • this product is sodium and sugar free

  • Inactive ingredients

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


  • Questions?

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


  • SPL UNCLASSIFIED SECTION

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

    Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products
    Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877
    © 2016, BI Pharmaceuticals, Inc. All rights reserved.
    Product of Spain. Manufactured in Mexico.


  • PRINCIPAL DISPLAY PANEL

    Zantac 75mg - 30ct Blister Packs
    NDC: 0597-0122-27

    ct6121b

  • PRINCIPAL DISPLAY PANEL

    Zantac 75mg - 80 ct Carton
    NDC: 0597-0122-81

    ct6125b

  • INGREDIENTS AND APPEARANCE
    ZANTAC 75 
    ranitidine tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0597-0122
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ranitidine hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine 75 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 Score no score
    Shape PENTAGON (5 sided) Size 3mm
    Flavor Imprint Code Z;75
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0597-0122-34 1 in 1 CARTON
    1 4 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0597-0122-54 1 in 1 CARTON
    2 60 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0597-0122-81 1 in 1 CARTON
    3 80 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:0597-0122-40 4 in 1 CARTON
    4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:0597-0122-61 100 in 1 CARTON
    5 1 in 1 POUCH; Type 0: Not a Combination Product
    6 NDC:0597-0122-96 1 in 1 CARTON
    6 96 in 1 BOTTLE; Type 0: Not a Combination Product
    7 NDC:0597-0122-08 1 in 1 POUCH; Type 0: Not a Combination Product
    8 NDC:0597-0122-01 2 in 1 CARTON
    8 1 in 1 POUCH; Type 0: Not a Combination Product
    9 NDC:0597-0122-37 3 in 1 CARTON
    9 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    10 NDC:0597-0122-13 1 in 1 CARTON
    10 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020520 12/21/2006
    Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
    Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
    Establishment
    Name Address ID/FEI Business Operations
    Boehringer Ingelheim Promeco S.A de C.V. 812579472 LABEL(0597-0122) , MANUFACTURE(0597-0122) , PACK(0597-0122) , ANALYSIS(0597-0122)
    Establishment
    Name Address ID/FEI Business Operations
    Patheon Manufacturing Services LLC 079415560 MANUFACTURE(0597-0122)