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

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 9, 2020

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  • Active ingredients (in each capsule)

    Omeprazole 20 mg

    Sodium Bicarbonate 1100 mg

  • Purpose

    Acid reducer

    Allows absorption of this omeprazole product

  • 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.
  • 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).

  • 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.
  • 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
  • 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

  • Questions or comments?

    1-800-719-9260

  • 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
  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE AND SODIUM BICARBONATE 
    omeprazole, sodium bicarbonate capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-732
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (blue band) Scoreno score
    ShapeCAPSULESize23mm
    FlavorImprint Code 732
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-732-011 in 1 CARTON08/25/2017
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:37808-732-033 in 1 CARTON08/25/2017
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20136108/25/2017
    Labeler - H E B (007924756)
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