Label: ESOMEPRAZOLE MAGNESIUM tablet, delayed release

  • NDC Code(s): 43598-469-28, 43598-469-42, 43598-469-52
  • Packager: Dr. Reddys Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 15, 2020

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

  • Active ingredient(s)

    *Esomeprazole 20 mg

    (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate, USP)  

  • Purpose

    Acid reducer

  • Use(s)

    • 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

    • 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 lightheadness·

    • frequent chest pain

    These may be signs of a serious condition. See your doctor.

    Ask a doctor before use if

    • 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

    • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

    Stop use and ask 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

    Pregnancy/Breastfeeding

    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 directions and warnings before use·
    • keep the carton. It contains important information
  • Storage

    · store at 20 to 25°C (68 to 77°F)

  • Inactive ingredients

    crospovidone, glyceryl monostearate, hypromellose, iron oxide red, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polysorbate 80, simethicone, sodium stearyl fumarate, sugar spheres (contains sucrose and maize starch), talc, titanium dioxide, triethyl citrate

  • Questions

    call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

  • SPL UNCLASSIFIED SECTION

    Tips for Managing Heartbun

    • Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chDistocolate, 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.

    Distributor:

    Dr. Reddy’s Laboratories Inc.,

    Princeton, NJ 08540

    Made in India

    Issued: 0420

  • Principal Display Panel

    Container 14's count:

    container

  • PRINCIPAL DISPLAY PANEL

    Carton 14's count:

    carton1

  • PRINCIPAL DISPLAY PANEL

    Carton 28s count

    carton2

  • PRINCIPAL DISPLAY PANEL

    Carton 42s count

    carton3

  • INGREDIENTS AND APPEARANCE
    ESOMEPRAZOLE MAGNESIUM 
    esomeprazole magnesium tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-469
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT) Esomeprazole20 mg
    Inactive Ingredients
    Ingredient NameStrength
    Crospovidone (UNII: 2S7830E561)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Mannitol (UNII: 3OWL53L36A)  
    Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Dimethicone 350 (UNII: 2Y53S6ATLU)  
    Sodium Stearyl Fumarate (UNII: 7CV7WJK4UI)  
    Sucrose (UNII: C151H8M554)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Triethyl Citrate (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorPINK (light pink) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 469
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43598-469-521 in 1 CARTON11/15/2020
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:43598-469-282 in 1 CARTON11/15/2020
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:43598-469-423 in 1 CARTON11/15/2020
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21157111/15/2020
    Labeler - Dr. Reddys Laboratories Inc (802315887)