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Acid Reducer (P and L Development of New York Corporation)

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TABLET 1 BOTTLE in 1 BOX (59726-127-10) > 150 TABLET in 1 BOTTLE Label Information

Complete Acid Reducer Information

  • 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 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
    • 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.


  • 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, FD&C yellow #6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and 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 150®

    Maximum Strength

    Ranitidine Tablets USP, 150 mg

    Acid Reducer

    Prevents and Relieves:

     Heartburn Associated with Acid Indigestion and Sour Stomach

    * This product is not manufactured or distributed by Boehringer Ingekheim Consumer Health Care Products, owner of the registered trademark Zantac 150©

    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 150 mg


  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    ranitidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-127
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIETHYL PHTHALATE (UNII: UF064M00AF)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color ORANGE Score no score
    Shape HEXAGON (6 SIDED) Size 10mm
    Flavor Imprint Code W;741
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59726-127-10 1 in 1 BOX
    1 150 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078653 03/25/2013
    Labeler - P and L Development of New York Corporation (800014821)
    Registrant - P and L Development of New York Corporation (800014821)