Label: ACID REDUCER- ranitidine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 10, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Ranitidine 150 mg (as ranitidine hydrochloride, USP 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 (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 CARTON OR INDIVIDUAL BLISTER UNIT 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, talc, titanium dioxide

  • QUESTIONS?

    or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

    DISTRIBUTED BY:

    WINCO FOODS, LLC, BOISE, ID 83704

    MADE IN INDIA

    5113377/0914

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Zantac 150®

    WinCo FOODS

    MAXIMUM STRENGTH

    RANITIDINE TABLETS, USP 150 mg/ACID REDUCER

    Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

    24 Tablets

    rani150carton24's
  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-243
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 9R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-243-2424 in 1 CARTON01/08/2015
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20053608/15/2012
    Labeler - WinCo Foods, LLC (056098817)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shasun Pharmaceuticals Limited915786829MANUFACTURE(67091-243)