Label: KIRKLAND SIGNATURE OMEPRAZOLE- omeprazole tablet, delayed release 

  • Label RSS
  • NDC Code(s): 63981-915-55
  • Packager: Costco Wholesale Company
  • 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 01/13

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

  • Active ingredient (in each tablet)

    Omeprazole 20 mg

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  • Purpose

    Acid reducer

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  • Uses

    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

    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

    warfarin, clopidogrel or cilostazol (blood-thinning medicines)
    prescription antifungal or anti-yeast medicines
    diazepam (anxiety medicine)
    digoxin (heart medicine)
    tacrolimus (immune system medicine)
    prescription antiretrovirals (medicines 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
    you get diarrhea

    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

    for 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; 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 use for more than 14 days unless directed by your doctor
    swallow whole. Do not chew or crush tablets
     

    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. Heartburn in children may sometimes be caused by a serious condition.
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  • Other information

    read the directions and warnings before use
    keep the carton. It contains important information.
    store at 20-25°C (68-77°F) and protect from moisture
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  • 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 or comments?

    1-800-719-9260

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  • Principal Display Panel

    OMEPRAZOLE Delayed Release Tablets 20 mg

    Acid Reducer

    Treats Frequent Heartburn!

    occurring 2 or more days a week

    Actual Size

    # 14-Day courses of Treatment {Replace “#” with the number of courses of treatment in the package}

    OMEPRAZOLE Delayed Release Tablets 20 mg Carton Image 1
    OMEPRAZOLE Delayed Release Tablets 20 mg Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    KIRKLAND SIGNATURE OMEPRAZOLE 
    omeprazole tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63981-915
    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  
    LACTOSE MONOHYDRATE  
    PROPYLENE GLYCOL  
    SODIUM LAURYL SULFATE  
    SODIUM STEARATE  
    SODIUM STEARYL FUMARATE  
    TALC  
    TITANIUM DIOXIDE  
    TRIETHYL CITRATE  
    MONOETHANOLAMINE  
    HYPROMELLOSES  
    Product Characteristics
    Color BROWN Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code 20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63981-915-55 3 in 1 CARTON
    1 14 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022032 02/27/2008
    Labeler - Costco Wholesale Company (103391843)
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