ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]

ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]
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NDC 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-68, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87
Set ID 888d9feb-fc9b-49cc-8361-30b5da86ea05
Category HUMAN OTC DRUG LABEL
Packager Boehringer Ingelheim Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number NDA021698
  • 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)
      • 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 INGREDIENT

    Inactive ingredients FD&C Blue No.1, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide

  • QUESTIONS

    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.

    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.

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL

    Zantac 150 mg Cool Mint - 24 Count Carton

    zantac-150-cool-mint-24ct
  • PRINCIPAL DISPLAY PANEL

    Zantac 150 mg Cool Mint - 65 Count Carton

    zantac-150-cool-mint-65ct
  • INGREDIENTS AND APPEARANCE
    ZANTAC MAXIMUM STRENGTH 150 COOL MINT 
    ranitidine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ranitidine hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine150 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    hypromelloses (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    sucralose (UNII: 96K6UQ3ZD4)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapePENTAGON (5 sided)Size4mm
    FlavorMINTImprint Code Z;150
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0597-0120-061 in 1 CARTON
    13 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0597-0120-081 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0597-0120-094 in 1 CARTON
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0597-0120-243 in 1 CARTON
    48 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0597-0120-381 in 1 CARTON
    58 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:0597-0120-501 in 1 CARTON
    650 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0597-0120-681 in 1 CARTON
    765 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0597-0120-8080 in 1 CARTON
    81 in 1 POUCH; Type 0: Not a Combination Product
    9NDC:0597-0120-8280 in 1 CARTON
    91 in 1 POUCH; Type 0: Not a Combination Product
    10NDC:0597-0120-871 in 1 CARTON
    1085 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:0597-0120-781 in 1 CARTON
    1178 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:0597-0120-762 in 1 CARTON
    128 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02169812/21/2006
    Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
    Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Manufacturing Services LLC079415560MANUFACTURE(0597-0120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boehringer Ingelheim Promeco S.A de C.V.812579472LABEL(0597-0120) , PACK(0597-0120) , MANUFACTURE(0597-0120) , ANALYSIS(0597-0120)