Label: OMEPRAZOLE AND SODIUM BICARBONATE- omeprazole, sodium bicarbonate capsule, gelatin coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 30, 2019

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

  • Active ingredients (in each capsule)

    Omeprazole 20 mg

    Sodium Bicarbonate 1100 mg

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  • Purpose

    Acid reducer

    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 a prescription drug. Acid reducers may interact with certain prescription drugs.

    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
    you develop a rash or joint pain

    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, 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 band around the capsule is missing or broken. Do not use if printed seal under cap is broken or missing.
    keep product out of high heat and humidity
    protect product from moisture
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  • Inactive ingredients

    FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Compare to Zegerid OTC® active ingredients

    Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg

    Omeprazole, 20 mg/Acid Reducer - Sodium Bicarbonate, 1100 mg/

    Allows Absorption of this Omeprazole Product

    Acid Reducer

    Treats Frequent Heartburn

    42 CAPSULES

    actual size

    Three 14-day courses of treatment

    omeprazole and sodium bicarbonate image
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  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE AND SODIUM BICARBONATE 
    omeprazole, sodium bicarbonate capsule, gelatin coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-732
    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) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1100 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE (blue band) Score no score
    Shape CAPSULE Size 23mm
    Flavor Imprint Code 732
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-732-01 1 in 1 CARTON 08/25/2017
    1 14 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:37808-732-03 3 in 1 CARTON 08/25/2017
    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
    ANDA ANDA201361 08/25/2017
    Labeler - H E B (007924756)
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