Label: NEXIUM 24HR- esomeprazole magnesium capsule, delayed release
NEXIUM 24HR CLEARMINIS- esomeprazole magnesium capsule, delayed release

  • NDC Code(s): 0573-2450-14, 0573-2450-15, 0573-2450-17, 0573-2450-28, view more
    0573-2450-42, 0573-2450-43, 0573-2450-44, 0573-2450-56, 0573-2452-14, 0573-2452-42, 0573-2452-43
  • Packager: Wyeth Consumer Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 12, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredient (in each capsule) Purpose
    (Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)
    Esomeprazole 20 mg Acid reducer
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  • INDICATIONS & USAGE

    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

    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 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

    • warfarin, clopidogrel or cilostazol (blood-thinning medicines)
    • prescription antifungal or anti-yeast medicines
    • digoxin (heart medicine)
    • diazepam (anxiety medicine)
    • tacrolimus or mycophenolate mofetil (immune system medicines)
    • 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

    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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  • DOSAGE & ADMINISTRATION

    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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  • STORAGE AND HANDLING

    Other Information

    • read the directions and warnings before use
    • keep the carton. It contains important information.
    • store at 20-25°C (68-77°F)
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  • INACTIVE INGREDIENT

    Nexium 24HR Capsules

    corn starch, D&C red no. 28, FD&C blue no. 1, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

    Nexium 24HR ClearMinis

    carmine, corn starch, FD&C blue no. 2, FD&C blue no. 2 aluminum lake, FD&C red no. 3, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

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  • QUESTIONS

    Questions or comments?

    call toll-free 1-866-226-1600

    Made in France

    For most recent product information, visit www.Nexium24HR.com

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  • PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Label

    Treats Frequent Heartburn

    Nexium®
    24HR
    esomeprazole magnesium
    delayed-release capsules
    20 mg/acid reducer

    May take 1 to 4 days for full effect

    14 Capsules
    Capsules

    One 14-day course of treatment

    PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Carton

    NDC 0573-2450-14

    Treats Frequent Heartburn

    Nexium®
    24HR
    esomeprazole magnesium
    delayed-release capsules
    20 mg/acid reducer

    Capsules

    May take 1 to 4 days for full effect

    14
    CAPSULES

    One 14-day course of treatment

    PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Carton
    Close
  • PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Blister Pack

    NDC 0573-2450-15

    Treats Frequent Heartburn

    Nexium®
    24HR
    esomeprazole magnesium
    delayed-release capsules
    20 mg/acid reducer

    May take 1 to 4 days
    for full effect

    14
    CAPSULES

    One 14-day course
    of treatment

    Capsules

    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 Capsule Bottle Blister Pack
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  • PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Label - Non-Child Resistant

    Treats Frequent Heartburn

    Nexium®
    24HR
    esomeprazole magnesium
    delayed-release capsules
    20 mg/acid reducer

    May take 1 to 4 days for full effect

    14 Capsules
    Capsules

    One 14-day course of treatment

    PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Label - Non-Child Resistant
    Close
  • PRINCIPAL DISPLAY PANEL - 28 Capsule Bottle Carton

    NDC 0573-2450-28

    Arthritis Foundation
    Ease of
    Use

    CAP

    Treats Frequent Heartburn

    Nexium®
    24HR
    esomeprazole magnesium
    delayed-release capsules
    20 mg/acid reducer

    Capsules

    28
    CAPSULES

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

    Two 14-day courses of treatment

    May take 1 to 4 days for full effect

    PRINCIPAL DISPLAY PANEL - 28 Capsule Bottle Carton
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  • PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Label - Clear Minis

    Treats Frequent Heartburn

    Nexium®
    24HR
    esomeprazole magnesium
    delayed-release capsules
    20 mg/acid reducer

    May take 1 to 4 days for full effect

    14 Capsules
    Clear Minis™

    One 14-day course of treatment

    PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Label - Clear Minis
    Close
  • PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Carton - Clear Minis

    NDC 0573-2452-14

    New
    mini capsule

    Treats Frequent Heartburn

    Nexium®
    24HR
    esomeprazole magnesium
    delayed-release capsules
    20 mg/acid reducer

    Clear Minis™

    14
    CAPSULES
    One 14-day course of treatment

    May take 1 to 4 days for full effect

    PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Carton - Clear Minis
    Close
  • PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton - Clear Minis

    NDC 0573-2452-42

    New
    mini capsule

    Treats Frequent Heartburn

    Nexium®
    24HR
    esomeprazole magnesium
    delayed-release capsules
    20 mg/acid reducer

    Clear Minis™

    42
    CAPSULES
    Three 14-day courses of treatment

    May take 1 to 4 days for full effect

    PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton - Clear Minis
    Close
  • INGREDIENTS AND APPEARANCE
    NEXIUM 24HR 
    esomeprazole magnesium capsule, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2450
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color PURPLE (amethyst) Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code NEXIUM;20;mg
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-2450-14 1 in 1 CARTON 05/27/2014
    1 14 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:0573-2450-15 1 in 1 BLISTER PACK 05/27/2014
    2 14 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0573-2450-28 2 in 1 CARTON 05/27/2014
    3 14 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:0573-2450-42 3 in 1 CARTON 05/27/2014
    4 14 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:0573-2450-43 3 in 1 BLISTER PACK 05/27/2014
    5 14 in 1 BOTTLE; Type 0: Not a Combination Product
    6 NDC:0573-2450-44 3 in 1 CARTON 05/27/2014
    6 14 in 1 BOTTLE; Type 0: Not a Combination Product
    7 NDC:0573-2450-56 2 in 1 PACKAGE 05/27/2014
    7 2 in 1 BLISTER PACK
    7 14 in 1 BOTTLE; Type 0: Not a Combination Product
    8 NDC:0573-2450-17 1 in 1 CARTON 05/27/2014
    8 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
    NDA NDA204655 05/27/2014
    NEXIUM 24HR CLEARMINIS 
    esomeprazole magnesium capsule, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2452
    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
    CARMINIC ACID (UNII: CID8Z8N95N)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color PURPLE (amethyst) , YELLOW Score no score
    Shape CAPSULE Size 10mm
    Flavor Imprint Code NEXIUM;20;mg
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-2452-14 1 in 1 CARTON 03/01/2017
    1 14 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:0573-2452-42 3 in 1 CARTON 03/01/2017
    2 14 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0573-2452-43 3 in 1 BLISTER PACK 03/01/2017
    3 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
    NDA NDA204655 03/01/2017
    Labeler - Wyeth Consumer Healthcare LLC (828831730)
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