ZANTAC 75 (RANITIDINE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]

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ZANTAC 75 (RANITIDINE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]
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NDC 67751-152-01, 67751-152-02
Set ID 9279ec21-82f8-40db-9f47-873968e9f58d
Category HUMAN OTC DRUG LABEL
Packager Navajo Manufacturing Company Inc.
Generic Name
Product Class
Product Number
Application Number NDA020520
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  • Drug Facts

  • Active ingredient (in each tablet)

    Ranitidine 75 mg (as ranitidine hydrochloride 84 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

    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, necks 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 individual foil pouch 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

    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 for Tips for Managing Heartburn

  • Package Labeling:

    Zantac 75

  • INGREDIENTS AND APPEARANCE
    ZANTAC 75 
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-152(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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    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:67751-152-011 in 1 CARTON09/17/2016
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67751-152-022 in 1 CARTON09/17/2016
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02052009/17/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)
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