Label: DG HEALTH ESOMEPRAZOLE MAGNESIUM- esomeprazole capsule, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 8, 2024

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

  • Active ingredient (in each capsule)

    Esomeprazole 20 mg

    (Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)

  • Purpose

    Acid reducer

  • Uses

    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 esomeprazole.
    Esomeprazole 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 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

    adults 18 years of age and older
    this product is to be used once a day (every 24 hours), every day for 14 days
    may take 1 to 4 days for full effect
     
    14-Day Course of Treatment
    swallow 1 capsule with a glass of water before eating in the morning
    take every day for 14 days
    do not take more than 1 capsule a day
    swallow whole. Do not crush or chew capsules.
    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 before use. 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)
  • Inactive ingredients

    acacia, D&C yellow #10, FD&C blue #1, FD&C red #3, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, menthol, methacrylic acid and ethyl acrylate copolymer dispersion, natural and artificial cool mint flavor, peppermint oil, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, spearmint oil, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

  • Questions or comments?

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  • Package/Label Principal Display Panel

    DG® health

    Compare to the active ingredient of Nexium® 24 HR

    Esomeprazole Magnesium Delayed-Release Capsules, 20 mg

    Acid Reducer

    Treats Frequent Heartburn

    24 HOUR

    Releases a cooling sensation in mouth and throat

    Cool Mint Flavor

    Flavored Capsules

    14 Capsules

    One 14-Day Course of Treatment

    Actual Capsule Size

    May take 1 to 4 days for full effect

    22h-vt-esomeprazole-magnesium
  • INGREDIENTS AND APPEARANCE
    DG HEALTH ESOMEPRAZOLE MAGNESIUM 
    esomeprazole capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-640
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE (UNII: N3PA6559FT) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorBLUE (sealed with green band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorMINTImprint Code L898
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-640-011 in 1 CARTON05/03/2024
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20719305/03/2024
    Labeler - Dolgencorp Inc (068331990)