GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]

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GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]
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NDC 0113-0058-03
Set ID bcf32242-de17-4da1-b707-4ce26262eb78
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number ANDA201361
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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

    •
    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 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 20-25oC (68-77oF)
    •
    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

    Treats Frequent Heartburn

    Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg

    Acid Reducer

    Allows Absorption of this Omeprazole Product

    Compare to active ingredients of Zegerid OTC®

    100% SATISFACTION GUARANTEED

    42 Capsules

    Three 14-Day Courses of Treatment

    Package Contains 3 Bottles

    732-c2-92-omeprazole-and-sodium-bicarbonate-1.jpg
    732-c2-92-omeprazole-and-sodium-bicarbonate-2.jpg
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE 
    omeprazole, sodium bicarbonate capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0058
    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:0113-0058-033 in 1 CARTON06/19/2017
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20136106/19/2017
    Labeler - L. Perrigo Company (006013346)
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