Label: TOPCARE OMEPRAZOLE- omeprazole tablet, delayed release

  • NDC Code(s): 76162-470-01, 76162-470-03
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 6, 2024

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  • Active ingredient (in each tablet)

    Omeprazole 20 mg

  • Purpose

    Acid reducer

  • 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.
    •
    omeprazole may cause severe skin reactions. Symptoms may include:
    •
    skin reddening
    •
    blisters
    •
    rash

    If an allergic reaction occurs, stop use and seek medical help right away.

    Do not use if you have:

    •
    trouble or pain swallowing food, vomiting with blood, or bloody or black stools
    •
    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

    These may be signs of a serious condition. See you doctor.

    Ask a doctor before use if you have:

    •
    had heartburn over 3 months. This may be a sign of a more serious condition.
    •
    frequent wheezing, particularly with heartburn
    •
    unexplained weight loss
    •
    nausea or vomiting
    •
    stomach pain

    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; some people get complete relief of symptoms within 24 hours

    14-Day Course of Treatment

    •
    swallow 1 tablet with a glass of water before eating in the morning
    •
    take every day for 14 days
    •
    do not take more than 1 tablet a day
    •
    do not use for more than 14 days unless directed by your doctor
    •
    swallow whole. Do not chew, crush, or suck tablets.

    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

    •
    read the directions and warnings before use
    •
    keep the carton. It contains important information.
    •
    store at 20-25˚C (68-77˚F) and protect from moisture
  • Inactive ingredients

    carnauba wax, FD&C blue #1/brilliant blue FCF aluminum lake, hypromellose, hypromellose acetate succinate, lactose monohydrate, menthol, monoethanolamine, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, sucralose, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    1-888-423-0139

  • Package/Label Principal Display Panel

    TopCare® health

    VALUE PACK!

    THREE-14 TABLET BOTTLES

    Omeprazole

    COMPARE TO PRILOSEC OTC®

    DELAYED RELEASE TABLETS 20 mg

    ACID REDUCER

    24 HR

    Treats Frequent Heartburn!

    SWALLOW – DO NOT CHEW

    COOL MINT COATED TABLET

    actual size

    42 TABLETS

    THREE 14-DAY COURSES OF TREATMENT • MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

    omeprazole image 1
    omeprazole image 2
  • INGREDIENTS AND APPEARANCE
    TOPCARE OMEPRAZOLE 
    omeprazole tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-470
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    HYPROMELLOSE ACETATE SUCCINATE, UNSPECIFIED (UNII: A7ZHS2RJ34)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize12mm
    FlavorMINT (COOL) Imprint Code 20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-470-033 in 1 CARTON09/22/2022
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:76162-470-011 in 1 CARTON09/22/2022
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02203209/22/2022
    Labeler - Topco Associates LLC (006935977)
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