Label: ACID REDUCER- ranitidine tablet

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

Drug Label Information

Updated October 15, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient (in each tablet)

    Ranitidine 150 mg (as ranitidine hydrochloride USP 167.414 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


    • 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
    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • unexplained weight loss
    • nausea or vomiting
    • stomach pain
  • 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 (1-800-222-1222) 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

    • TAMPER EVIDENT: Do Not Use If The Carton Or Printed Foil Under Cap Is Open or Torn

    • store at 20° to 25°C (68° to 77°F)
    • avoid excessive heat or humidity
    • this product is sugar free
    • USP Dissolution Test Pending
  • Inactive ingredients

    croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin

  • Questions?

    call 1-888-309-9030

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

  • Consumer Information

    What you should know about
    MAXIMUM STRENGTH
    Ranitidine Tablets USP, 150 mg
    ACID REDUCER

    (Please read all of this information before taking MAXIMUM STRENGTH
    Ranitidine Tablets 150 mg. Save this leaflet for future reference.)

    What are MAXIMUM STRENGTH Ranitidine Tablets 150 mg?


    • MAXIMUM STRENGTH Ranitidine Tablets 150 mg contain 150 mg of ranitidine (as ranitidine hydrochloride USP, 167.414 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

    Excellent Safety Record


    • The ingredient in MAXIMUM STRENGTH Ranitidine Tablets 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets 150 mg has been taken safely with many frequently prescribed medications.
    • MAXIMUM STRENGTH Ranitidine Tablets 150 mg are sugar free.

    What symptoms do MAXIMUM STRENGTH Ranitidine Tablets 150 mg relieve and prevent?


    • MAXIMUM STRENGTH Ranitidine Tablets 150 mg relieve and prevent heartburn associated with acid indigestion and sour stomach.
    • Certain foods or beverages, and even lying down to sleep can cause heartburn associated with acid indigestion and sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort.

    Figure1
    How should I take MAXIMUM STRENGTH Ranitidine Tablets 150 mg?


    • 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.
    • This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours).
    • MAXIMUM STRENGTH Ranitidine Tablets 150 mg should not be given to children under 12 years old unless directed by a doctor.
    • Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

    How do MAXIMUM STRENGTH Ranitidine Tablets 150 mg work?

    • MAXIMUM STRENGTH Ranitidine Tablets 150 mg reduce the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

    Tips for managing heartburn

     

    • Do not lie flat or bend over soon after eating
    • Do not eat late at night, or just before bedtime
    • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
    • Eat slowly and do not eat big meals
    • If you are overweight, lose weight
    • If you smoke, quit smoking
    • Raise the head of your bed
    • Wear loose fitting clothing around your stomach

    When should I see a doctor?

    • 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
      • 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
      • frequent chest pain
      • frequent wheezing, particularly with heartburn
      • unexplained weight loss
      • nausea or vomiting
      • stomach pain
    • 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 healthcare professional before use.

    • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

    Questions? Call 1-888-309-9030

    BOTTLES: Do not use if the carton or printed foil under cap is open or torn.

    DISTRIBUTED BY:
    DOLGENCORP, LLC
    100 MISSION RIDGE,
    GOODLETTSVILLE, TN 37072
    MADE IN INDIA

    Revised: 05/ 2019

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (24 Tablets Bottle)

    DG™ health

    Maximum Strength Acid Reducer

    Ranitidine Tablets 150 mg
    Acid Reducer


    PREVENTS & RELIEVES HEARTBURN
    Associated with

    Acid Indigestion

    and Sour Stomach

     

    8 Tablets (8 Doses)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (8 Tablets Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (24's Tablets)


    DG™ health

    Compare to the
    active Ingredient
    of Zantac 1509®*


    Maximum Strength
    Acid
    Reducer
    Ranitidine Tablets 150 mg
    Acid Reducer

    PREVENTS & RELIEVES
    HEARTBURN
    Associated with
    Acid Indigestion
    and Sour Stomach

    150 mg         8 Tablets (8 Doses)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (8 Tablets)

  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-092
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITE (White to Off-white) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code K;43
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-092-791 in 1 CARTON05/17/2019
    18 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20757805/17/2019
    Labeler - Dolgencorp, LLC (068331990)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(55910-092) , MANUFACTURE(55910-092)