Label: ZANTAC 75- ranitidine tablet, coated

  • NDC Code(s): 0597-0122-01, 0597-0122-08, 0597-0122-13, 0597-0122-34, view more
    0597-0122-37, 0597-0122-40, 0597-0122-54, 0597-0122-61, 0597-0122-81, 0597-0122-96
  • Packager: Boehringer Ingelheim Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 20, 2019

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

  • 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.

  • INDICATIONS & USAGE

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0122
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorpinkScoreno score
    ShapePENTAGON (5 sided)Size3mm
    FlavorImprint Code Z;75
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0597-0122-341 in 1 CARTON12/21/200611/30/2021
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0597-0122-541 in 1 CARTON12/21/200611/30/2021
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0597-0122-811 in 1 CARTON12/21/200611/30/2021
    380 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0597-0122-404 in 1 CARTON12/21/200611/30/2021
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0597-0122-61100 in 1 CARTON12/21/200611/30/2021
    51 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:0597-0122-961 in 1 CARTON12/21/200611/30/2021
    696 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0597-0122-081 in 1 POUCH; Type 0: Not a Combination Product12/21/200611/30/2021
    8NDC:0597-0122-012 in 1 CARTON12/21/200611/30/2021
    81 in 1 POUCH; Type 0: Not a Combination Product
    9NDC:0597-0122-373 in 1 CARTON12/21/200611/30/2021
    910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    10NDC:0597-0122-131 in 1 CARTON12/21/200611/30/2021
    1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02052012/21/200611/30/2021
    Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
    Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Manufacturing Services LLC079415560manufacture(0597-0122)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boehringer Ingelheim Promeco S.A de C.V.812579472pack(0597-0122) , analysis(0597-0122) , label(0597-0122) , manufacture(0597-0122)