Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release


Drug Label Information

Updated November 14, 2019

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  • Active ingredient(s) in each capsule

    *Esomeprazole 20 mg

    (Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)

  • Purpose

    Acid reducer

  • Use(s)

    • 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

    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 lightheadness
    • 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

    • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

    Stop use and ask 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

    • each capsule contains: magnesium, 15 mg
    • read directions and warnings before use
    • keep the carton. It contains important information
    • store at 20 to 25°C (68 to 77°F)

  • Inactive ingredients

    acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1,  ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide

  • Questions or comments

    call toll-free weekdays 8 AM to 10 PM EST at 1-888-375-3784

  • 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.

    Revised: 0419

  • Placeholder Image


    esomeprazole magnesium capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-527(NDC:43598-407)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT) Esomeprazole20 mg
    Inactive Ingredients
    Ingredient NameStrength
    acetyltributyl citrate (UNII: 0ZBX0N59RZ)  
    Dibutyl Sebacate (UNII: 4W5IH7FLNY)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Gelatin (UNII: 2G86QN327L)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Magnesium Oxide (UNII: 3A3U0GI71G)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Povidone K30 (UNII: U725QWY32X)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Shellac (UNII: 46N107B71O)  
    Sucrose (UNII: C151H8M554)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUE (light blue cap) , BLUE (dark blue body) Scoreno score
    FlavorImprint Code RDY;327
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-527-141 in 1 CARTON03/01/2020
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:53943-527-423 in 1 CARTON03/01/2020
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Discount Drug Mart, Inc (047741335)