ZANTAC 150 ACID REDUCER (RANITIDINE) TABLET [LIL' DRUG STORE PRODUCTS, INC]

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ZANTAC 150 ACID REDUCER (RANITIDINE) TABLET [LIL' DRUG STORE PRODUCTS, INC]
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NDC 66715-9736-2, 66715-9736-3, 66715-9736-6, 66715-9736-8
Set ID 5e569962-0763-4669-96c2-93012ff6cd6c
Category HUMAN OTC DRUG LABEL
Packager Lil' Drug Store Products, Inc
Generic Name
Product Class
Product Number
Application Number NDA021698
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  • SPL UNCLASSIFIED SECTION

    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 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

    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • unexplained weight loss
    • nausea or vomiting
    • stomach pain
    • 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

    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 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, synthetic red iron oxide, titanium dioxide, triacetin

  • Questions?

    call 1-888-285-9159, or visit www.zantacotc.com

  • SPL UNCLASSIFIED SECTION

    PRODUCT MANUFACTURED BY:
    BOEHRINGER INGELHEIM CONSUMER
    HEALTH CARE PRODUCTS
    DIVISION OF BOEHRINGER INGELHEIM
    PHARMACEUTICALS, INC.
    RIDGEFIELD, CT 06877

    PRODUCT REPACKAGED AND
    DISTRIBUTED BY:
    LIL' DRUG STORE PRODUCTS, INC.
    CEDAR RAPIDS, IA 52402

  • PRINCIPAL DISPLAY PANEL - 5 Tablet Pouch Carton

    EZ Paks
    Stores & Travels Easily!

    MAXIMUM STRENGTH

    Zantac
    150®
    RANITIDINE TABLETS 150 mg / ACID REDUCER

    STRONG
    FAST
    LASTING

    PREVENTS & RELIEVES
    HEARTBURN     associated with
    acid indigestion and sour stomach

    5
    TABLETS
    IN 5 PACKETS OF 1 TABLET

    Lil'
    Drug Store®

    Principal Display Panel - 5 Tablet Pouch Carton
  • INGREDIENTS AND APPEARANCE
    ZANTAC 150   ACID REDUCER
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9736
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ranitidine Hydrochloride (UNII: BK76465IHM) (Ranitidine - UNII:884KT10YB7) Ranitidine150 mg
    Inactive Ingredients
    Ingredient NameStrength
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Triacetin (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapePENTAGON (5 SIDED)Size4mm
    FlavorImprint Code Z;150
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9736-22 in 1 CARTON11/01/2010
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-9736-33 in 1 CARTON11/01/2010
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:66715-9736-85 in 1 CARTON11/01/2010
    31 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:66715-9736-620 in 1 CARTON11/01/201012/31/2017
    41 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02169811/01/2010
    Labeler - Lil' Drug Store Products, Inc (093103646)
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