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Ranitidine (P and L Development of New York Corporation)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE in 1 BOX (59726-580-10) > 10 TABLET in 1 BOTTLE Label Information

Complete Ranitidine Information

  • Active ingredient (in each tablet)

    Ranitidine 75 mg (as ranitidine hydrochloride 84 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 eating or drinking 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

    Ask a doctor before use if you have
    • frequent wheezing, particularly with heartburn
    • frequent chest pain
    • stomach pain
    • unexplained weight loss
    • nausea or vomiting
    • 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.


  • 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

    • 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, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, titanium dioxide.


  • Questions or comments?

    Call 1-877-753-3935 Monday- Friday 9AM-5PM EST


  • Principal Display Panel

    *Compare to the active ingredient in Zantac 75®

    Ranitidine Tablets USP, 75 mg

    Acid Reducer

    Prevents and relieves:

    Heartburn associated with acid indigestion and sour stomach

    10 Tablets

    10 Doses

    * This product is not manufactured or distributed by Boehringer Ingelheim Consumer health care products, owner of the registered trademark Zantac 75®

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    DO NOT USE IF PRINTED FOIL UNDER BOTTLE CAP IS OPEN OR TORN

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

    Distributed by:

    PL Developments

    200 Hicks street

    Westbury NY 11590

    PRODUCT OF INDIA


  • Product Label

    PL Developments

    Ranitidine 75 mg


  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-580
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 75 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIETHYL PHTHALATE (UNII: UF064M00AF)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color PINK Score no score
    Shape HEXAGON (6 SIDED) Size 8mm
    Flavor Imprint Code W;75
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59726-580-10 1 in 1 BOX
    1 10 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078884 03/19/2013
    Labeler - P and L Development of New York Corporation (800014821)
    Registrant - P and L Development of New York Corporation (800014821)