Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release


Drug Label Information

Updated February 14, 2020

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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

  • 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


    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

    warfarin, clopidogrel or cilostazol (blood-thinning medicines)

    prescription ant fungal or anti-yeast medicines

    digoxin (heart medicine)

    diazepam (anxiety medicine)

    tacrolimus or mycophenolate mofetil (immune system medicine)

    prescription antiretrovirals (medicines for HIV infection)

    methotrexate (arthritis medicine)

    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.

  • 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.

  • Principal Display Panel

    14 ct Carton:


    14 ct Bottle


    esomeprazole magnesium capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-277(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:69842-277-141 in 1 CARTON01/02/2019
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69842-277-282 in 1 CARTON01/02/2019
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69842-277-423 in 1 CARTON01/02/2019
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69842-277-151 in 1 CARTON05/20/2019
    414 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - CVS Pharmacy (062312574)