QUALITY CHOICE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]

QUALITY CHOICE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-170-42
Set ID 0022ca14-9177-4fe9-90f3-1d67592d8d6c
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association
Generic Name
Product Class
Product Number
Application Number NDA022032
  • Active ingredient (in each tablet)

    Omeprazole delayed-release tablet, 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

    Do not use if you have trouble or pain swallowing food, vomiting with blood, or 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

    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 (immune system medicine)
    • prescription antiretrovirals (medicines for HIV infection)

    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

    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.

  • Directions


    • 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 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 or crush 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)
    • keep product out of high heat and humidity
    • protect product from moisture
  • Inactive ingredients

    carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate

    Questions or comments?

    Call 1-800-540-3765

  • Principal Display Panel

    NDC 63868-170-42

    QUALITY CHOICE

    Treats Frequent Heartburn!

    Occurring 2 or more days a week

    Omeprazole

    Delayed Release Tablets, 20mg

    Frequent Heartburn Relief

    Acid Reducer

    42 Tablets

    Three 14-day courses of treatment

    omeprazole carton

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE OMEPRAZOLE  
    omeprazole tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-170
    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)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) (UNII: 36BGF0E889)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeOVAL (capsule-shaped) Size13mm
    FlavorImprint Code 20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-170-423 in 1 CARTON
    114 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02203203/01/2014
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)

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