Label: ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release

  • NDC Code(s): 71713-202-01, 71713-202-03
  • Packager: Thirty Madison Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 21, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient(s) in each capsule

    *Esomeprazole 20 mg

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

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  • Purpose

    Acid reducer

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  • 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

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  • 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

    • 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 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.

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  • 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.

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  • 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)

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  • 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

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  • Questions or comments

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

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  • SPL UNCLASSIFIED SECTION

    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.

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  • Container Label

    Container Label:

    Bottle

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  • Carton label
  • INGREDIENTS AND APPEARANCE
    ESOMEPRAZOLE MAGNESIUM 
    esomeprazole magnesium capsule, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71713-202
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT) Esomeprazole 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Shellac (UNII: 46N107B71O)  
    Sucrose (UNII: C151H8M554)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color BLUE (light blue cap) , BLUE (dark blue body) Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code RDY;327
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71713-202-01 1 in 1 CARTON 05/31/2019
    1 14 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:71713-202-03 3 in 1 CARTON 05/31/2019
    2 14 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA207673 05/31/2019
    Labeler - Thirty Madison Inc (080774087)
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