ZANTAC 150 MAXIMUM STRENGTH COOL MINT (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]

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  • ZANTAC 150 MAXIMUM STRENGTH COOL MINT (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]

ZANTAC 150 MAXIMUM STRENGTH COOL MINT (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]
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NDC 41167-0320-0, 41167-0320-1, 41167-0320-2, 41167-0320-3, 41167-0320-4, 41167-0320-5, 41167-0320-6, 41167-0320-7
Set ID 46da3875-7a43-4a13-ae0b-3243fe2c2f56
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number NDA021698
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  • SPL UNCLASSIFIED SECTION

    Zantac 150 Cool Mint Tablets

    Drug Facts

  • Active ingredient (in each tablet) 

    Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

  • Purpose

    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 ■ store at 20-25°C (68-77°F)

    ■ avoid excessive heat or humidity       ■ this product is sodium and sugar free

  • Inactive ingredients

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

  • Questions?

    call 1-800-633-1610 or visit www.zantacotc.com

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

  • PRINCIPAL DISPLAY PANEL

    Cool Mint TABLETS
    Maximum Strength
    Zantac
    150
    40 Tablets

    PRINCIPAL DISPLAY PANEL Cool Mint TABLETS Maximum Strength Zantac 150 40 Tablets

  • INGREDIENTS AND APPEARANCE
    ZANTAC 150  MAXIMUM STRENGTH COOL MINT
    ranitidine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapePENTAGON (5 SIDED)Size4mm
    FlavorImprint Code Z;150
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0320-11 in 1 CARTON09/23/2018
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-0320-23 in 1 CARTON09/23/2018
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-0320-04 in 1 CARTON07/26/2018
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:41167-0320-61 in 1 CARTON01/04/2018
    440 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:41167-0320-31 in 1 CARTON01/04/2018
    550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:41167-0320-41 in 1 CARTON01/04/2018
    665 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:41167-0320-71 in 1 CARTON01/04/2018
    778 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    8NDC:41167-0320-51 in 1 CARTON01/04/2018
    890 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02169801/04/2018
    Labeler - Chattem, Inc. (003336013)
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