MAXIMUM STRENGTH ZANTAC (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]

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MAXIMUM STRENGTH ZANTAC (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]
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NDC 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0597-0121-66, 0597-0121-68, 0597-0121-78, 0597-0121-80, 0597-0121-82, 0597-0121-85, 0597-0121-90, 0597-0121-94
Set ID 4da36a98-7363-4a8a-9bfe-5dfa7d2e1268
Category HUMAN OTC DRUG LABEL
Packager Boehringer Ingelheim Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number NDA021698
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  • 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.

  • INDICATIONS & USAGE

  • KEEP OUT OF REACH OF CHILDREN

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0121
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 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
    Colorpink (Dark Pink) Scoreno score
    ShapePENTAGON (5 sided)Size4mm
    FlavorImprint Code Z;150
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0597-0121-061 in 1 CARTON12/21/200611/30/2021
    13 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0597-0121-501 in 1 CARTON12/21/200611/30/2021
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0597-0121-081 in 1 POUCH; Type 0: Not a Combination Product12/21/200611/30/2021
    4NDC:0597-0121-094 in 1 CARTON12/21/200611/30/2021
    48 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0597-0121-243 in 1 CARTON12/21/200611/30/2021
    58 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:0597-0121-381 in 1 CARTON12/21/200611/30/2021
    68 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:0597-0121-641 in 1 CARTON12/21/200611/30/2021
    765 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0597-0121-681 in 1 CARTON12/21/200611/30/2021
    865 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0597-0121-8080 in 1 CARTON12/21/200611/30/2021
    91 in 1 POUCH; Type 0: Not a Combination Product
    10NDC:0597-0121-8280 in 1 CARTON12/21/200611/30/2021
    101 in 1 POUCH; Type 0: Not a Combination Product
    11NDC:0597-0121-941 in 1 CARTON12/21/200611/30/2021
    1145 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:0597-0121-902 in 1 CARTON12/21/200611/30/2021
    1245 in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:0597-0121-851 in 1 CARTON12/21/200611/30/2021
    1385 in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:0597-0121-012 in 1 CARTON12/21/200611/30/2021
    1450 in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:0597-0121-781 in 1 CARTON12/21/200611/30/2021
    1578 in 1 BOTTLE; Type 0: Not a Combination Product
    16NDC:0597-0121-661 in 1 CARTON12/21/200611/30/2021
    1640 in 1 BOTTLE; Type 0: Not a Combination Product
    17NDC:0597-0121-112 in 1 CARTON12/21/200611/30/2021
    1760 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02169812/21/200611/30/2021
    Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
    Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Manufacturing Services LLC079415560manufacture(0597-0121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boehringer Ingelheim Promeco S.A de C.V.812579472label(0597-0121) , analysis(0597-0121) , manufacture(0597-0121) , pack(0597-0121)
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