Label: EXCHANGE SELECT ACID REDUCER- ranitidine hydrochloride tablet 

  • Label RSS
  • NDC Code(s): 55301-271-39
  • Packager: Army & Air Force Exchange Service
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/12

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

  • Active ingredient (in each tablet)

    Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

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  • Purpose

    Acid reducer

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  • 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
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  • 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 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.

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  • 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
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  • Other information

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

    colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, titanium dioxide.

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  • Questions or comments?

    1-800-719-9260

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  • Consumer Information

    What you should know about Ranitidine Tablets, USP 75 mg Acid Reducer

    Ranitidine Tablets, USP 75 mg

    (Please read all of this information before taking Ranitidine Tablets, USP 75 mg. Save this leaflet for future reference.)

    What is Ranitidine Tablet 75 mg?

    Ranitidine Tablet contains 75 mg of ranitidine (as ranitidine hydrochloride, 84 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

    Excellent safety record

    Ranitidine Tablets 75 mg has been used safely and effectively for years as an over-the-counter medication.
    Ranitidine Tablets 75 mg are sugar free.

    What symptoms does Ranitidine Tablet 75 mg treat and prevent?

    Ranitidine Tablet 75 mg relieves and prevents 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 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.

    Leaflet Image

    How should I take Ranitidine Tablet 75 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). Ranitidine Tablets 75 mg should not be given to children under 12 years old unless directed by a doctor.

    How does Ranitidine Tablet 75 mg work?

    Ranitidine Tablet 75 mg reduces the production of stomach acid. This is what makes Ranitidine Tablets 75 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

    Additional 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?

    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
    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
    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? Call 1-800-719-9260

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

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

    DISTRIBUTED BY PERRIGO, ALLEGAN, MI 49010

    Made in India

    :27100 00 J2

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  • Principal Display Panel

    Ranitidine Tablets 75 mg

    ACID REDUCER

    Compare to the active ingredient of Zantac 75®

    Prevents and Relieves

    Heartburn Associated with Acid Indigestion & Sour Stomach

    # DOSES {Replace "#" with number of tablets in package}

    Acid Reducer Carton Image 1
    Acid Reducer Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    EXCHANGE SELECT ACID REDUCER 
    ranitidine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55301-271
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 75 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    DIETHYL PHTHALATE  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    TITANIUM DIOXIDE  
    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:55301-271-39 1 in 1 CARTON
    1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076760 09/12/2012
    Labeler - Army & Air Force Exchange Service (001695568)
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