Label: REGULAR STRENGTH ACID REDUCER- ranitidine tablet

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

Drug Label Information

Updated October 14, 2014

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  • 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 any 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 minutesbefore 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 INDIVIDUAL BLISTER IS OPEN OR TORN
    •
    store at 20º - 25ºC (68º - 77ºF)
    •
    avoid excessive heat or humidity
    •
    this product is sodium and sugar free
  • Inactive ingredients

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

  • Questions

    call 1-800-406-7984

  • Principal display panel

    FAMILY
    wellness

    COMPARE TO THE ACTIVE INGREDIENT OF ZANTAC 150*

    Maximum Strength
    Acid Reducer
    Ranitidine Tablets, USP 150 mg

    Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

    24 TABLETS

    DISTRIBUTED BY
    FAMILY DOLLAR SERVICES, INC.,
    10401 MONROE RD,
    MATTHEWS, NC 28105 USA

    5110360 0614

    MADE IN INDIA

     

    Ranitidine_150mg_24's

    Ranitidine_150mg_24's

  • INGREDIENTS AND APPEARANCE
    REGULAR STRENGTH ACID REDUCER 
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-351
    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)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 9R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-351-243 in 1 CARTON
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:55319-351-651 in 1 CARTON
    265 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20053606/28/2011
    Labeler - Family Dollar (024472631)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shasun Pharmaceuticals Limited915786829API MANUFACTURE(55319-351)
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