Label: NEXIUM 24HR- esomeprazole magnesium tablet

  • NDC Code(s): 0573-2451-14, 0573-2451-42
  • Packager: Wyeth Consumer Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 12, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Esomeprazole 20 mg (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate)

  • PURPOSE

    Purpose

    Acid reducer

  • 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
  • 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
    • 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.

  • 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 tablet with a glass of water before eating in the morning
      • take every day for 14 days
      • do not take more than 1 tablet a day
      • swallow whole. Do not crush or chew tablets.
      • 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.
  • 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)
  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, crospovidone, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, paraffin, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, sucrose, talc, titanium dioxide, triethyl citrate

  • QUESTIONS

    Questions or comments?

    call toll-free weekdays 9 AM to 5 PM EST at 1-866-226-1600

    Made in France

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

    Nexium is a registered trademark of AstraZeneca AB and is used under license.

  • PRINCIPAL DISPLAY PANEL - 14 Tablet Bottle Label

    Treats Frequent Heartburn

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

    May take 1 to 4 days for full effect

    14 Tablets
    Tablets

    One 14-day course of treatment

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

    NDC 0573-2451-14

    See new warning

    Treats Frequent Heartburn

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

    Tablets

    May take 1 to 4 days for full effect

    14
    TABLETS

    One 14-day course of treatment

    PRINCIPAL DISPLAY PANEL - 14 Tablet Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 42 Tablet Bottle Carton

    See new warning
    NDC 0573-2451-42

    Treats Frequent Heartburn

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

    Tablets

    May take 1 to 4 days for full effect

    42
    TABLETS

    Three 14-day courses of treatment

    PRINCIPAL DISPLAY PANEL - 42 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NEXIUM 24HR 
    esomeprazole magnesium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2451
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code N;20;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2451-141 in 1 CARTON02/06/2016
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-2451-423 in 1 BLISTER PACK02/06/2016
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20792002/06/2016
    Labeler - Wyeth Consumer Healthcare LLC (828831730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-2451) , LABEL(0573-2451) , MANUFACTURE(0573-2451) , PACK(0573-2451)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Consumer Healthcare LLC828831730ANALYSIS(0573-2451) , MANUFACTURE(0573-2451)