Label: RANITIDINE tablet, coated

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

Drug Label Information

Updated November 15, 2011

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  • 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    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

    • Blister: do not use if individual unit is open or torn 
      Bottle: do not use if printed foil under bottle cap is open or torn
    • store at 20°-25°C (68°-77°F)
    • avoid excessive heat or humidity
    • this product is sugar free
  • Inactive Ingredients

    colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD and C yellow # 6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.
  • QUESTIONS

    Questions or comments?
    Call 1-800-346-6854

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

    Manufactured by:
    Wockhardt Limited,
    Mumbai, India.

    Distributed by:
    Wockhardt USA LLC.
    20 Waterview Blvd.
    Parsippany, NJ 07054
    USA.

    Rev.151111
  • PRINCIPAL DISPLAY PANEL

    500 T Label

    500 T Carton

  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55648-741
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIETHYL PHTHALATE (UNII: UF064M00AF)  
    Product Characteristics
    Colororange (orange colored film coated) Scoreno score
    ShapeHEXAGON (6 sided)Size10mm
    FlavorImprint Code W741
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55648-741-011 in 1 CARTON
    110 in 1 BOTTLE
    2NDC:55648-741-021 in 1 CARTON
    2100 in 1 BOTTLE
    3NDC:55648-741-051 in 1 CARTON
    3500 in 1 BOTTLE
    4NDC:55648-741-0310 in 1 CARTON
    410 in 1 BLISTER PACK
    5NDC:55648-741-066000 in 1 POUCH
    6NDC:55648-741-0030000 in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07865311/26/2007
    Labeler - WOCKHARDT LIMITED (650069115)
    Establishment
    NameAddressID/FEIBusiness Operations
    WOCKHARDT LIMITED676257570manufacture
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