RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]

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  • RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]

RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]
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NDC 68016-352-30, 68016-352-60
Set ID 92e1e60c-be24-4b20-8a2a-a39d03cc3cf3
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC.
Generic Name
Product Class
Product Number
Application Number ANDA201745
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  • ACTIVE INGREDIENT (IN EACH TABLET)

    Ranitidine 75 mg (as ranitidine hydrochloride USP, 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

    •
    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 (1-800-222-1222).

  • 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

    •
    TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER 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

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide

  • QUESTIONS?

    call 1-800-406-7984

    Read the directions, consumer information leaflet and warnings before use.

    Keep the carton. It contains important information.

    DISTRIBUTED BY

    CHAIN DRUG CONSORTIUM

    3301 NW BOCA RATON BLVD

    SUITE 101, BOCA RATON, FL 33431

  • PRINCIPAL DISPLAY PANEL

    Premier Value®

    NDC 68016-352-60

    Ranitidine Tablets, USP 75 mg

    Acid Reducer

    Regular Strength

    60 Tablets

    Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

    †Compare to the active ingredient of Zantac 75®

    †This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals Inc., owner of the registered trademark Zantac 75®.

    This is the 60 count bottle carton label for Premier Value Ranitidine tablets, USP 75 mg.
  • INGREDIENTS AND APPEARANCE
    RANITIDINE - ACID REDUCER 
    ranitidine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-352
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code OR;606
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-352-6060 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68016-352-3030 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20174507/10/2012
    Labeler - Chain Drug Consortium, LLC. (101668460)
    Registrant - Ohm Laboratories Inc. (184769029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shasun Pharmaceuticals Limited915786829MANUFACTURE(68016-352)
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