Label: ESOMEPRAZOLE MAGNESIUM tablet, delayed release

  • NDC Code(s): 58602-840-05, 58602-840-61, 58602-840-62
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 17, 2023

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

  • Drug Facts

    Active ingredient (in each tablet)


    *Esomeprazole 20 mg
    (Each film-coated delayed-release tablet 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.
    ■ Esomeprazole may cause severe skin reactions.
       Symptoms may include:
       ■  skin reddening ■  blisters ■  rash
    If an allergic reaction occurs, stop use and seek medical help 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

    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 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.

    Other information

    • read the directions and warnings before use
    • keep the carton. It contains important information.
    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, hypromellose, low substituted hydroxy propyl cellulose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, mono and di-glycerides, polyethylene glycol, polysorbate 80, red iron oxide, sodium stearyl fumarate, 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)

    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:  
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India  

    Code: TS/DRUGS/22/2009      

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

    AUROHEALTH

    NDC 58602-840-05

    Esomeprazole Magnesium
    Delayed-Release Tablets 20 mg*

    Acid Reducer
    24 HR

    May take 1 to 4 days for full effect
    Treats Frequent Heartburn
    14 Tablets
    One 14-day course of treatment


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

    #Compare to Nexium® 24 HR
    Active ingredient

    AUROHEALTH

    NDC 58602-840-05
    See new warning information

    Esomeprazole Magnesium
    Delayed-Release 
    Tablets 20 mg*

    Acid Reducer
    24 HR

    Treats Frequent Heartburn

    May take 1 to 4 days for full effect
    14 Tablets
    One 14-day course of treatment


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)
  • INGREDIENTS AND APPEARANCE
    ESOMEPRAZOLE MAGNESIUM 
    esomeprazole magnesium tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-840
    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)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    HYDROXYPROPYL CELLULOSE (20000 WAMW) (UNII: KZQ570MOA5)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW) (UNII: 7773C1ROEU)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MICROCRYSTALLINE CELLULOSE 301 (UNII: W7YXH6D4BD)  
    MICROCRYSTALLINE CELLULOSE 302 (UNII: 91B875MM4H)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    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
    ColorPINK (Light pink) Scoreno score
    ShapeOVAL (Oblong, Biconvex) Size13mm
    FlavorImprint Code K;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-840-051 in 1 CARTON07/12/2023
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-840-612 in 1 CARTON07/12/2023
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-840-623 in 1 CARTON07/12/2023
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21447307/12/2023
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-840) , MANUFACTURE(58602-840)