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Acid Reducer (L Perrigo Company)

Available Formats

Dosage Form Package Information Links
TABLET 3 BLISTER PACK in 1 CARTON (0113-0047-62) > 8 TABLET in 1 BLISTER PACK Label Information
TABLET 1 BOTTLE in 1 CARTON (0113-0047-71) > 50 TABLET in 1 BOTTLE Label Information

Complete Acid Reducer Information

  • 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

    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. (1-800-222-1222)


  • 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

    • do not use if printed foil under cap is broken or missing (Bottle Only)
    • do not use if blister unit is broken or torn (Blister Only)
    • avoid excessive heat or humidity
    • store at 20° - 25°C (68° - 77°F)
    • this product is sugar free

  • Inactive ingredients

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


  • Questions or comments?

    1-800-719-9260


  • 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, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

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

    MAXIMUM STRENGTH Ranitidine Tablets 150 mg relieve and prevent heartburn associated with acid indigestion and sour stomach.

    image 1

    Certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion or 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.

    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.

    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.

    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
    Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers 

    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 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.

    Questions or comments?1-800-719-9260

    BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn. Bottle contains desiccant.

    BLISTERS: Do not use if the individual blister unit is open or torn.

    perrigo

    Made in India

    Revision 11/11

    04709 00 J1


  • Principal Display Panel

    Maximum Strength

    Ranitidine Tablets 150 mg

    Acid Reducer

    Prevents & Relieves

    Heartburn

    Acid Indigestion

    Sour Stomach

    Compare to active ingredient of Zantac 150®

    (# Doses) {Replace "#" with the number of tablets in the package}

    Acid Reducer Carton Image 1
    Acid Reducer Carton Image 2

  • INGREDIENTS AND APPEARANCE
    ACID REDUCER  MAXIMUM STRENGTH
    ranitidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0047
    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)  
    Product Characteristics
    Color ORANGE Score no score
    Shape HEXAGON (6 sided) Size 11mm
    Flavor Imprint Code W;741
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0113-0047-62 3 in 1 CARTON
    1 8 in 1 BLISTER PACK
    2 NDC:0113-0047-71 1 in 1 CARTON
    2 50 in 1 BOTTLE
    3 NDC:0113-0047-02 1 in 1 CARTON
    3 24 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078653 02/19/2008
    Labeler - L. Perrigo Company (006013346)