Label: ZEGERID OTC- omeprazole and sodium bicarbonate capsule

  • NDC Code(s): 11523-7265-1, 11523-7265-3
  • Packager: Bayer HealthCare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 30, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each capsule) Purpose
    Omeprazole 20 mg Acid reducer
    Sodium Bicarbonate 1100 mg Allows absorption of this omeprazole product
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  • 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

    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
    • 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
    • a sodium-restricted diet

    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 or mycophenolate mofetil (immune system medicines)
    • prescription antiretrovirals (medicines for HIV infection)
    • methotrexate (arthritis medicine)
    • any other prescription drugs. Sodium bicarbonate may interact with certain prescription drugs

    Stop use and ask 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.

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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, although some people get complete relief of symptoms within 24 hours
      • 14-Day Course of Treatment
        • swallow 1 capsule with a glass of water at least 1 hour before eating in the morning
        • take every day for 14 days
        • do not take more than 1 capsule a day
        • do not chew or crush the capsule
        • do not open capsule and sprinkle on 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

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

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  • Other information

    • each capsule contains: sodium 303 mg
    • read the directions, warnings and accompanying label information before use
    • store at 20°-25°C (68°-77°F)
    • tamper-evident: do not use if the blue band around the capsule is missing or broken. Do not use if foil inner seal imprinted with, "Sealed for your protection" is missing, open or broken.
    • keep product out of high heat and humidity
    • protect product from moisture
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  • Inactive ingredients

    croscarmellose sodium, FD&C blue No. 1, gelatin, magnesium stearate, pharmaceutical ink, polysorbate 80, titanium dioxide

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  • Questions or comments?

    Questions or comments?

    Call 1-888-4-ZEG-OTC (1-888-493-4682) between 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday or visit www.ZegeridOTC.com

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  • SPL UNCLASSIFIED SECTION

    © 2015 Bayer.

    Dist by: Bayer HealthCare LLC, Whippany, NJ 07981
    Product of Spain.

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  • PRINCIPAL DISPLAY PANEL - 42 Capsule Carton

    Treats Frequent Heartburn

    Zegerid

    OTC ®

    • Omeprazole 20 mg/Acid Reducer

    • Sodium Bicarbonate 1100 mg/

    Allows Absorption of this Omeprazole Product

    42

    CAPSULES

    Three 14-Day Courses of Treatment

    42 count carton

    42 count carton

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  • INGREDIENTS AND APPEARANCE
    ZEGERID OTC 
    omeprazole and sodium bicarbonate capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7265
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1100 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (with blue band) Score no score
    Shape CAPSULE Size 23mm
    Flavor Imprint Code ZEG;20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-7265-1 1 in 1 CARTON 04/01/2010
    1 14 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:11523-7265-3 3 in 1 CARTON 04/01/2010
    2 14 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022281 04/01/2010
    Labeler - Bayer HealthCare LLC (968091715)
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