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

  • NDC Code(s): 0573-2450-02, 0573-2450-14, 0573-2450-15, 0573-2450-17, view more
    0573-2450-28, 0573-2450-42, 0573-2450-43, 0573-2450-44, 0573-2452-02, 0573-2452-14, 0573-2452-42, 0573-2452-43
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 9, 2022

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

  • Active ingredient (in each capsule)

    Esomeprazole 20 mg

    (Each delayed-release capsule corresponds to 22.3 mg

    esomeprazole magnesium trihydrate)

    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
    Esomeprazole may cause severe skin reactions. Symptoms include:
    skin reddening
    blisters
    rash

    If an allergic reaction occurs, stop use and seek medical attention right away.

    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 Repeated 14-Day Courses (if needed)
    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
    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 (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

    Inactive Ingredients (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

  • QUESTIONS

    Questions or comments?

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

  • Additional Information

    KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.

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

    or yellow band around the center of each capsule is broken or missing.

    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.

    Distributed by: GSK Consumer Healthcare,

    Warren, NJ 07059

    ©2022 GSK group of companies or its licensor

    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

    NDC 0573-2450-14

    See new warning information

    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

    000078381 Front Carton

    Nexium 24HR Capsules 14 ct
  • PRINCIPAL DISPLAY PANEL

    NDC 0573-2452-14

    See new warning information

    Treats Frequent Heartburn

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

    Clear Minis™

    May take 1 to 4 days for full effect

    14
    CAPSULES
    One 14-day course of treatment

    000078392 Front Carton

    Nexium 24HR Clear Minis 14 ct
  • INGREDIENTS AND APPEARANCE
    NEXIUM 24HR 
    esomeprazole magnesium capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2450
    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)  
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorPURPLE (amethyst) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code NEXIUM;20;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2450-141 in 1 CARTON05/27/2014
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-2450-151 in 1 BLISTER PACK05/27/201412/31/2022
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0573-2450-282 in 1 CARTON05/27/2014
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0573-2450-423 in 1 CARTON05/27/2014
    414 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0573-2450-433 in 1 BLISTER PACK05/27/2014
    514 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0573-2450-443 in 1 CARTON05/27/2014
    614 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0573-2450-171 in 1 CARTON05/27/201404/29/2016
    714 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0573-2450-021 in 1 CARTON10/31/2014
    82 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20465505/27/2014
    NEXIUM 24HR CLEARMINIS 
    esomeprazole magnesium capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2452
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorPURPLE (amethyst) , YELLOWScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code NEXIUM;20;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2452-141 in 1 CARTON03/01/2017
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-2452-423 in 1 CARTON03/01/2017
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0573-2452-433 in 1 BLISTER PACK03/01/201708/31/2017
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0573-2452-021 in 1 CARTON03/01/2017
    42 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20465503/01/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-2450, 0573-2452) , LABEL(0573-2450, 0573-2452) , MANUFACTURE(0573-2450, 0573-2452) , PACK(0573-2450, 0573-2452)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Consumer Healthcare Canada ULC203812479ANALYSIS(0573-2450, 0573-2452) , LABEL(0573-2450, 0573-2452) , MANUFACTURE(0573-2450, 0573-2452) , PACK(0573-2450, 0573-2452)