Label: ZEGERID OTC- omeprazole and sodium bicarbonate capsule, gelatin coated

  • NDC Code(s): 11523-7276-1, 11523-7276-2
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 10, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each capsule)

    Omeprazole 20 mg

    Sodium Bicarbonate 1100 mg

  • PURPOSE

    Purpose

    Acid reducer

    Allows absorption of this omeprazole product

  • INDICATIONS & USAGE

    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

    Warnings

    Allergy alert: Do not use if you are allergic to omeprazole

  • DO NOT USE

    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 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 DOCTOR/PHARMACIST

    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

    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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-1222).

  • Directions

    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

    Other information

    ● each tablet 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

  • INACTIVE INGREDIENT

    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

    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

  • 42 count 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

    Zegerid Carton 42 ct

  • INGREDIENTS AND APPEARANCE
    ZEGERID OTC 
    omeprazole and sodium bicarbonate capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7276
    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) SODIUM BICARBONATE1100 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (blue band) Scoreno score
    ShapeOVALSize23mm
    FlavorImprint Code ZEG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-7276-11 in 1 CARTON10/01/2017
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11523-7276-21 in 1 CARTON10/01/2017
    242 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20136110/01/2017
    Labeler - Bayer HealthCare LLC. (112117283)