Label: DG HEALTH OMEPRAZOLE- omeprazole tablet, delayed release

  • NDC Code(s): 55910-915-01, 55910-915-02, 55910-915-03, 55910-915-30, view more
    55910-915-74
  • Packager: Dolgencorp, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 22, 2019

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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

    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 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.
    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 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) and protect 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?

    1-888-309-9030

  • Principal Display Panel

    See current Drug Facts

    Compare to Prilosec OTC®

    Omeprazole

    Delayed Release Tablets 20 mg

    Acid Reducer

    Treats Frequent Heartburn!

    24 HR

    THIS ITEM IS ELECTRONICALLY PROTECTED

    20 mg

    14 Tablets

    One 14-Day Course of Treatment

    Actual Tablet Size

    May take 1 to 4 days for full effect

    omeprazole image
  • INGREDIENTS AND APPEARANCE
    DG HEALTH OMEPRAZOLE 
    omeprazole tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-915
    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)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-915-302 in 1 CARTON06/13/2011
    114 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:55910-915-7414 in 1 CARTON02/14/2010
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:55910-915-022 in 1 CARTON05/20/2012
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:55910-915-011 in 1 CARTON07/06/201307/06/2013
    414 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:55910-915-033 in 1 CARTON07/24/2013
    514 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02203202/14/2010
    Labeler - Dolgencorp, LLC (068331990)