Label: OMEPRAZOLE  DELAYED RELEASE- omeprazole tablet, delayed release 

  • Label RSS
  • NDC Code(s): 64861-303-01, 64861-303-02, 64861-303-03
  • Packager: Dexcel Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: 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 04/10

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

  • Omeprazole Delayed Release Tablets, 20 mg Drug Facts


    Active ingredient (in each tablet)
    Omeprazole delayed-release tablet, 20 mg
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  • PURPOSE

    Purpose
    Acid reducer

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  • INDICATIONS & USAGE


    Use
    • treats frequent heartburn (occurs 2 or more days a week)
    • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

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  • WARNINGS


    Warning
    Allergy alert:  Do not use if you are allergic to omeprazole

    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.

    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 or 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

    Ask a doctor or pharmacist before use if you are taking

    • clopidogrel bisulfate (anti-blood clotting medicine)
    • warfarin (blood-thinning medicine)
    • prescription antifungal or anti-yeast medicines
    • diazepam (anxiety medicine)
    • digoxin (heart medicine)
    • tacrolimus (immune system medicine)
    • atazanavir (medicine for HIV infection)

    Stop use and ask a doctor if

    • your heartburn continues or worsens
    • you need to take this product for more than 14 days
    • you need to take more than 1 course of treatment every 4 months

    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.
    (1-800-2221222)

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  • SPL UNCLASSIFIED SECTION


    Directions
    • adults 18 years of age and older
    • this product is to be used once a day (every 24 hours), every day for 14 days
    • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
    14-Day Course of Treatment
    • swallow 1 tablet with a glass of water before eating in the morning
    • take every day for 14 days
    • do not take more than 1 tablet a day
    • do not chew or crush the tablets
    • do not crush tablets in food
    • do not use for more than 14 days unless directed by your doctor
    Repeated 14-Day Courses (if needed)
    • you may repeat a 14-day course every 4 months
    • do not take for more than 14 days or more often than every 4 months unless directed by a doctor
    • children under 18 years of age:  ask a doctor
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  • SPL UNCLASSIFIED SECTION


    Other information
    • read the directions, warnings, and package insert before use
    • keep the carton and package insert.  They contain important information.
    • store at 20-25°C (68-77°F)
    • keep product out of high heat and humidity
    • protect product from moisture
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  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate

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  • QUESTIONS


    Questions or comments?
    1-800-719-9260
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  • Inner Carton Label


    Treats Frequent Heartburn!
    Occurring 2 or More Days a Week

    Omeprazole
    delayed release tablets 20 mg
    acid reducer

    14 TABLETS
    One 14-day course of treatment

    Inner Carton Label

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  • Blister Label


    Omeprazole DR Tablets
    20 mg

    Acid reducer
    Push tablet through foil.
    Dexcel Ltd.
    1 Dexcel St.  Or Akiva
    30600, Israel

    Do not chew or crush tablets

    Do not crush tablets in food


    Blister Label

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  • Bottle Label


    NOT FOR RESALE

    Treats Frequent Heartburn!
    Occurring 2 or More Days a Week

    Omeprazole Delayed
    Release Tablets 20 mg

    Acid Reducer

    14 Tablets
    One 14-day course of treatment

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    Manufactured by:
    Dexcel® Ltd.
    1 Dexcel St., Or Akiva
    30600, Israel

    Made in Israel

    Bottle Label Part 1
    Bottle Label Part 2
    Bottle Label Part 3



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  • Patient Package Insert


    Omeprazole Delayed Release Tablets 20 mg

    Acid Reducer

    Please read all of this package insert before taking Omeprazole Delayed Release Tablets 20 mg.  Save this to read, as you need.

    How Omeperazole Delayed Release Tablets 20 mg Work For Your Frequent Heartburn

    Omeprazole Delayed Release Tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers.  Omeprazole Delayed Release Tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid.  Omeprazole Delayed Release Tablets 20 mg are to be used once a day (every 24 hours), every day for 14 days.

    What to Expect When Using Omeprazole Delayed Release Tablets 20 mg

    Omeprazole Delayed Release Tablets 20 mg are a different type of medicine from antacids and other acid reducers.  Omeprazole Delayed Release Tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours.  Make sure you take the entire 14 days of dosing to treat your frequent heartburn.

    Safety Record

    For years, doctors have prescribed omeprazole to treat acid-related conditions in millions of people safely.

    Who Should Take Omeprazole Delayed Release Tablets 20 mg

    This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week.
    • Omeprazole Delayed Release Tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief or heartburn.
    How to Take Omeprazole Delayed Release Tablets 20 mg

    14-Day Course of Treatment
    • Swallow 1 tablet with a glass of water before eating in the morning.
    • Take every day for 14 days.
    • Do not take more than 1 tablet a day
    • Do not chew or crush the tablets.
    • Do not crush tablets in food.
    • Do not use for more than 14 days unless directed by your doctor.
    It is important not to chew or crush these tablets, or crush the tablets in food.  This decreases how well Omeprazole Delayed Release Tablets 20 mg work.

    When to Take Omeprazole Delayed Release Tablets 20 mg Again

    You may repeat a 14-day course of therapy every 4 months.


    When to Talk to Your Doctor

    Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

    Warnings and When to Ask Your Doctor

    Allergy alert:  Do not use if you are allergic to omeprazole

    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.

    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
    Ask a doctor or pharmacist before use if you are taking
    • clopidogrel bisulfate (anti-blood clotting medicine)
    • warfarin (blood-thinning medicine)
    • prescription antifungal or anti-yeast medicines
    • diazepam (anxiety medicine)
    • digoxin (heart medicine)
    • tacrolimus (immune system medicine)
    • atazanavir (medicine for HIV infection)
    Stop use and ask a doctor if
    • your heartburn continues or worsens
    • you need to take this product for more than 14 days
    • you need to take more than 1 course of treatment every 4 months
    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)

    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 and 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.
    How are Omeprazole Delayed Release Tablets 20 mg Sold

    Omeprazole Delayed Release Tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes.  These sizes contain one, two and three 14-day courses of treatment, respectively.  Do not use for more than 14 days in a row unless directed by your doctor.  For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

    For Questions or Comments About Omeprazole Delayed Release Tablets 20 mg

    Call 1-800-719-9260

    Made in Israel

    Manufactured by:
    DEXCEL® LTD.
    Southern Industrial Zone
    Or Akiva 30600, Israel


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  • Bulk 7-Count Blister Pack Carton Label


    70 Tablets

    OMEPRAZOLE DR TABLETS 20 MG OTC
    Acid reducer

    FOR REPACKAGING ONLY

    Manufactured by:  DEXCEL® LTD.
    Southern Industrial Zone, Or Akiva 30600, Israel

    • Store at 15° - 25°C (59° - 77°F)
    • Keep product out of high heat and humidity
    • Protect product from moisture
    Bulk 7-Count Blister Carton Label
    Close
  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE   DELAYED RELEASE
    omeprazole tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64861-303
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Omeprazole (Omeprazole) Omeprazole 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    Carnauba Wax  
    Ferric Oxide Red  
    Ferric Oxide Yellow  
    Hypromellose  
    Hypromellose Acetate Succinate 12070923 (3 MM2/S)  
    Lactose Monohydrate  
    Ethanolamine  
    Propylene Glycol  
    Sodium Lauryl Sulfate  
    Sodium Starch Glycolate Type A Potato  
    Sodium Stearate  
    Sodium Stearyl Fumarate  
    Talc  
    Titanium Dioxide  
    Triethyl Citrate  
    Product Characteristics
    Color brown (brownish) Score no score
    Shape OVAL (capsule-shaped) Size 13mm
    Flavor Imprint Code 20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64861-303-01 14 in 1 BOTTLE, PLASTIC
    2 NDC:64861-303-02 10 in 1 CARTON
    2 7 in 1 BLISTER PACK
    3 NDC:64861-303-03 2 in 1 CARTON
    3 7 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022032 03/01/2008
    Labeler - Dexcel Ltd. (600534200)
    Establishment
    Name Address ID/FEI Business Operations
    Dexcel Ltd. 600534200 analysis, label, manufacture, pack
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