Label: ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG capsule, delayed release
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI capsule, delayed release

  • NDC Code(s): 25000-075-76, 25000-112-76
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 18, 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 22.3 mg esomeprazole magnesium trihydrate)

  • 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 include:
    o skin reddening
    o blisters
    o rash
    If an allergic reaction occurs, stop use and seek medical attention 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 (1-800-222-1222) 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
    • 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

    Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg

    Inactive ingredients black iron oxide, eudragit, FD&C Blue 1, FD&C Red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate.


    Esomeprazole Magnesium Delayed-Release Capsules 20 mg (Mini Capsules) 

    Inactive ingredients black iron oxide, corn starch, D&C red 27 aluminum lake, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate

  • Questions or comments

    Call 1-877-376-4271 (weekdays 9 AM to 5 PM)


    Tips for Managing Heartburn
    • Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
    • Eat slowly and do not eat big meals.
    • Do not eat late at night or just before bedtime.
    • Do not lie flat or bend over soon after eating.
    • Raise the head of your bed.
    • Wear loose-fitting clothing around your stomach.
    • If you are overweight, lose weight.
    • If you smoke, quit smoking.


    Manufactured for:
    Time-Cap Labs, Inc.
    7 Michael Avenue,
    Farmingdale,
    NY 11735, USA


    Manufactured by:
    Marksans Pharma Ltd.
    Plot No. L-82, L-83
    Verna Indl. Estate
    Verna, Goa-403722, India 

  • PRINCIPAL DISPLAY PANEL

    NDC: 25000-075-76

    Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg

    14 count bottle label


    esomeprazole-dr-20mg-14s-bottle-label


    NDC: 25000-075-76

    Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg

    14 count carton label


    esomeprazole-dr-20mg-14s-ifc-label

    NDC: 25000-112-76

    Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules)

    14 count bottle label


    esomeprazole-dr-minis-20mg-14s-bottle-label


    NDC: 25000-112-76

    Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules)

    14 count carton label


    esomeprazole-dr-minis-20mg-14s-carton-caps


  • INGREDIENTS AND APPEARANCE
    ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG 
    esomeprazole magnesium delayed-release capsules, 20 mg capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-075
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    SHELLAC (UNII: 46N107B71O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    Product Characteristics
    ColorPURPLE (golden cap and violet transparent body having light violet to violet colour band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 75
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-075-761 in 1 CARTON09/30/2023
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21726409/30/2023
    ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI 
    esomeprazole magnesium delayed-release 20 mg mini capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorYELLOW (golden yellow opaque cap, transparent body, light violet to violet color band) Scoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code 112
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-112-761 in 1 CARTON03/18/2024
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21726403/18/2024
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-075, 25000-112)