Label: EQUALINE ESOMEPRAZOLE MAGNESIUM- esomeprazole capsule, delayed release

  • NDC Code(s): 41163-539-01, 41163-539-02, 41163-539-03
  • Packager: Supervalu Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 4, 2021

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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

  • 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 and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

  • Questions or comments?

    1-855-423-2630

  • Package/Label Principal Display Panel

    compare to Nexium® 24 HR active ingredient

    24 hour esomeprazole magnesium

    delayed-release capsules, 20 mg acid reducer

    treats frequent heartburn

    may take 1 to 4 days for full effect

    actual size

    CAPSULES

    14 capsules

    ONE 14-DAY COURSE OF TREATMENT

    1 BOTTLE INSIDE

    898-el-esomeprazole-magnesium
  • INGREDIENTS AND APPEARANCE
    EQUALINE ESOMEPRAZOLE MAGNESIUM 
    esomeprazole capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-539
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColorBLUE (opaque) Scoreno score
    ShapeCAPSULE (oblong) Size14mm
    FlavorImprint Code L898
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-539-011 in 1 CARTON09/25/2017
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41163-539-022 in 1 CARTON03/06/201803/01/2021
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41163-539-033 in 1 CARTON02/28/201803/01/2021
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20719309/25/2017
    Labeler - Supervalu Inc (006961411)
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