RANITIDINE TABLET [SHOPKO STORES OPERATING CO., LLC.]

RANITIDINE TABLET [SHOPKO STORES OPERATING CO., LLC.]
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NDC 37012-127-50
Set ID c182e00b-9bb0-4af8-bc35-ee8eeda6ab18
Category HUMAN OTC DRUG LABEL
Packager Shopko Stores Operating Co., LLC.
Generic Name
Product Class
Product Number
Application Number ANDA078653
  • 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     
    • unexplained weight loss 
    • 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 
    • frequent wheezing, particularly with heartburn 
    • nausea or vomiting      
  • Stop use and ask a doctor if

    • your heartburn continues or worsens
    • stomach pain continues
    • you need to take this product for more than 14 days
  • If pregnant or breast-feeding,

    ask a health care 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 older:
      • 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 of age: ask a doctor
  • Other information

    • do not use if printed foil under cap is torn or open
    • store at controlled room temperature 20°-25°C (68°-77°F)
    • avoid excessive heat or humidity
    • this product is sugar free
    • *This product is not manufactured or distributed by Glaxosmithkline Consumer Healthcare, owner of the registered trademark Zantac® 150
  • Inactive Ingredients

    colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD&C yellow # 6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.
  • Principal display panel

    SHOPKO®

    Maximum Strength HEARTBURN

    Ranitidine Tablets, USP 150 mg

    Acid Reducer

    One tablet relieves: heartburn, acid indigestion & sour stomach

    *Compare to Zantac 150® active ingredient

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

    Packaged by:

    PL Developments

    200 Hicks street

    Westbury, NY 11590, USA

    Questions or comments?

    call toll free 1-877-753-3935

    Product of INDIA

  • Product Label

    shopko ranitidine 50 count

    Ranitidine 150 mg

  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIETHYL PHTHALATE (UNII: UF064M00AF)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeHEXAGON (6 SIDED)Size10mm
    FlavorImprint Code W;741
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-127-501 in 1 CARTON
    150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07865307/11/2010
    Labeler - Shopko Stores Operating Co., LLC. (023252638)

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