Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release

  • NDC Code(s): 46122-538-03, 46122-538-04, 46122-538-74
  • Packager: Amerisource Bergen
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 11, 2021

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

  • Drug Facts

    Active ingredient   (in each capsule) 


    *Esomeprazole 20 mg
    (Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

  • 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)
    • Meets USP dissolution test 2
  • Inactive ingredients

    colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.

    Questions or comments?


    call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)


    Distributed By Amerisource Bergn
    1300 Morris Drive, Chesterbrook, PA 19087
    Questions or Concerns?       
    www.mygnp.com

    Made in India
    Code: TS/DRUGS/22/2009


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label)

    Rx
    GOOD                         NDC 46122-538-74                        
    NEIGHBOR                                      
    PHARMACY®
                                          
                                                            24 HR
    Esomeprazole Magnesium
    delayed release capsules USP 20 mg*
    Acid Reducer
    Treats Frequents Heartburn         Capsules
    May take 1 to 4 days for full effect    
    14 Capsules  |one 14-day course  of treatment

    esomeprazole-fig1.jpg


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton)

    Rx
    GOOD                                                Compare to Nexium® 24 HR
    NEIGHBOR                                       active ingredient**
    PHARMACY®
                                      NDC 46122-538-74
    See new warning information                24 HR
    Esomeprazole
    Magnesium

    delayed release capsules USP 20 mg*
    Acid Reducer
    Treats Frequents Heartburn
    May take 1 to 4 days for full effect           actual
    14                    Capsules                         size
    Capsules
     |     one 14-day course
                            of treatment



    esomeprazole-fig2.jpg
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (28 Capsule Container Carton)

    Rx
    GOOD
    NEIGHBOR                                  Compare to Nexium® 24 HR  active ingredient**
    PHARMACY®                               NDC 46122-538-03
    See new warning information              24 HR
    Esomeprazole Magnesium
    delayed release capsules USP 20 mg*
    Acid Reducer
    Treats Frequents Heartburn
    May take 1 to 4 days for full effect     Capsules      actual
                                                                                    size
    28 Capsules | two 14-day courses
    (2 bottles of 14 each) | of treatment

    esomeprazole-fig3.jpg



  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Capsule Container Carton)

    Rx
    GOOD
    NEIGHBOR             Compare to Nexium® 24 HR  active ingredient**
    PHARMACY®         NDC 46122-538-04
    See new warning information              24 HR
    Esomeprazole Magnesium
    delayed release capsules USP 20 mg*
    Acid Reducer
    Treats Frequents Heartburn
    May take 1 to 4 days for full effect     Capsules      actual
                                                                                      size
    42 Capsules                | three 14-day courses of treatment
    (3 bottles of 14 each)

    esomeprazole-fig4.jpg


  • INGREDIENTS AND APPEARANCE
    ESOMEPRAZOLE MAGNESIUM 
    esomeprazole magnesium capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-538
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    AMMONIA (UNII: 5138Q19F1X)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code I81
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-538-741 in 1 CARTON10/16/2017
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:46122-538-032 in 1 CARTON10/16/2017
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:46122-538-043 in 1 CARTON10/16/2017
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20933910/16/2017
    Labeler - Amerisource Bergen (007914906)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(46122-538) , MANUFACTURE(46122-538)