EXCHANGE SELECT ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]

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EXCHANGE SELECT ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]
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NDC 55301-898-01, 55301-898-03
Set ID 5fa9089f-90d1-48b6-bb79-c6171eeeaa03
Category HUMAN OTC DRUG LABEL
Packager Army & Air Force Exchange Service
Generic Name
Product Class
Product Number
Application Number ANDA207193
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  • Active ingredient (in each capsule)

    Esomeprazole 20 mg

    (Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)

  • Purpose

    Acid reducer

  • 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

    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. (1-800-222-1222)

  • 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.
  • 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 ingredients

    FD&C blue no. 1, FD&C red no. 3, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to Nexium® 24 HR active ingredient

    See New Warning Information

    Esomeprazole Magnesium Delayed-Release Capsules, 20 mg/Acid Reducer

    24 HOUR

    TREATS FREQUENT HEARTBURN

    CAPSULES

    Actual size

    42 CAPSULES

    Three 14-day courses of treatment

    May take 1 to 4 days for full effect

    quality value

    898-cz-esomeprazole-magnesium-1.jpg
    898-cz-esomeprazole-magnesium-2.jpg
  • INGREDIENTS AND APPEARANCE
    EXCHANGE SELECT ESOMEPRAZOLE MAGNESIUM 
    esomeprazole capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-898
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE (UNII: N3PA6559FT) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorBLUE (opaque) Scoreno score
    ShapeCAPSULE (oblong) Size14mm
    FlavorImprint Code L898
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55301-898-011 in 1 CARTON12/04/2017
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55301-898-033 in 1 CARTON12/04/2017
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20719312/04/2017
    Labeler - Army & Air Force Exchange Service (001695568)
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