Label: NEXIUM 24HR- esomeprazole magnesium tablet

  • NDC Code(s): 0573-2451-14, 0573-2451-28, 0573-2451-42, 0573-2451-43
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 1, 2021

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

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

    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.

    Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or

    missing.

  • Additional Information

    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

    NDC 0573-2451-42

    Nexium®

    esomeprazole magnesium

    delayed-release tablets

    20 mg/acid reducer

    24HR

    See new warning information

    Treats Frequent Heartburn

    Tablets

    May take 1 to 4 days for full effect

    42 TABLETS

    Three 14-day courses of treatment

    PAA114854 Front Carton

    Nexium 24 Hr Tablets  42ct
  • 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 (120 .MU.M) (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
    3NDC:0573-2451-282 in 1 CARTON07/01/2021
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0573-2451-433 in 1 PACKAGE07/01/2021
    414 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 - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-2451) , LABEL(0573-2451) , MANUFACTURE(0573-2451) , PACK(0573-2451)