Home > Drugs A-Z > Ranitidine

Ranitidine (Shasun Pharmaceuticals Limited)

Available Formats

Dosage Form Package Information Links
TABLET 1 BAG in 1 BOX (57910-404-33) > 6000 TABLET in 1 BAG Label Information
TABLET 600 TABLET in 1 BAG (57910-404-32) Label Information

Complete Ranitidine Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • 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

    • with other acid reducers
    • if you have kidney disease, except under the advice and supervision of a doctor
    • 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.

  • Ask a doctor before use if you have

    • nausea or vomiting
    • stomach pain
    • unexplained weight loss
    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • 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:

              â—‹ to relieve symptoms, swallow 1 tablet with a glass of water

              â—‹ to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause              heartburn

              â—‹ can be used up to twice daily (do not take more than 2 tablets in 24 hours)

              â—‹ do not chew tablet

    children under 12 years: ask a doctor


  • Other information

    • Blister: do not use if individual unit is open or torn Bottle: do not use of 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 sodium and sugar free

  • Inactive ingredients

    Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearte, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide


  • Questions?

    call 1-800-406-7984


  • SPL UNCLASSIFIED SECTION

    IMPORTANT

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

    Distributed by: Ohm Laboratories Inc, 1385 Livingston Avenue, North Brunsluick, NJ 08902

    MADE IN INDIA


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57910-404
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 150 mg
    Inactive Ingredients
    Ingredient Name Strength
    COLLOIDAL 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 (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color PINK Score no score
    Shape OVAL (Oval Shaped) Size 12mm
    Flavor Imprint Code RX;828
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57910-404-32 600 in 1 BAG
    2 NDC:57910-404-33 1 in 1 BOX
    2 6000 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA200536 06/28/2011
    Labeler - Shasun Pharmaceuticals Limited (650064850)
    Registrant - Shasun Pharmaceuticals Limited (915786829)
    Establishment
    Name Address ID/FEI Business Operations
    Shasun Pharmaceuticals Limited 915786829 Manufacture