Label: WAL ZAN 150- ranitidine hydrochloride tablet, film coated

  • NDC Code(s): 0363-0950-02, 0363-0950-04, 0363-0950-09, 0363-0950-64
  • Packager: Walgreen Company
  • 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 08/14

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

  • Active ingredient (in each tablet)

    Ranitidine 150 mg (as ranitidine hydrochloride 168 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

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  • Do not use

    with other acid reducers
    if you have kidney disease, except under the advice and supervision of a doctor
    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.
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  • Ask a doctor before use if you have

    nausea or vomiting
    stomach pain
    unexplained weight loss
    frequent chest pain
    frequent wheezing, particularly with heartburn
    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
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  • 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)

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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 (up to 2 tablets in 24 hours)
    do not chew tablet
    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 sodium and sugar free
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  • Inactive ingredients

    FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, natural and artificial mint flavor, sucralose, titanium dioxide, triacetin

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  • Questions or comments?

    1-800-719-9260

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  • Consumer Information

    What you should know about MAXIMUM STRENGTH Ranitidine Tablets 150 mg

    Acid Reducer

    Cool Mint Tablets

    (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.

    • When swallowed, MAXIMUM STRENGTH Ranitidine Tablets 150 mg release a cooling sensation in the mouth and throat.

    Image 1

    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 sodium and 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.

    Eating or drinking 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.

    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 (up to 2 tablets in 24 hours).

    • Do not chew tablet.

    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 right away. (1-800-222-1222)

    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.

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

    DISTRIBUTED BY

    PERRIGO®

    ALLEGAN, MI 49010 U.S.A.

    : 905B5 00 J1

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  • Package/Label Principal Display Panel

    MAXIMUM STRENGTH

    Wal – Zan® 150

    Ranitidine Tablets USP, 150 mg

    Acid Reducer

    Prevents & relieves heartburn associated with acid indigestion & sour stomach

    Releases a cooling sensation in mouth & throat

    SUGAR FREE

    Actual Size

    COOL MINT TABLETS

    24 TABLETS

    Compare to Zantac 150® active ingredient

    24 COOL MINT TABLETS (24 DOSES)

    Walgreens Wal-Zan 150 Image 1
    Walgreens Wal-Zan 150 Image 2
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  • INGREDIENTS AND APPEARANCE
    WAL ZAN 150 
    ranitidine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0950
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SUCRALOSE  
    TITANIUM DIOXIDE  
    TRIACETIN  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code L950
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0950-02 1 in 1 CARTON
    1 24 in 1 BOTTLE
    2 NDC:0363-0950-09 1 in 1 CARTON
    2 65 in 1 BOTTLE
    3 NDC:0363-0950-04 1 in 1 CARTON
    3 85 in 1 BOTTLE
    4 NDC:0363-0950-64 1 in 1 CARTON
    4 32 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091429 09/17/2011
    Labeler - Walgreen Company (008965063)
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