Label: ESOMEPRAZOLE capsule

  • NDC Code(s): 69618-056-14, 69618-056-42
  • Packager: Reliable 1 Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 9, 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 20.7 mg esomeprazole magnesium, USP)

  • Purpose

    Acid reducer

  • Uses

    treats frequent heartburn (occurs 2 or more days a week)

    not intended for innediate 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 sings of a serious condition. See your doctor.

  • ASK 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, particulary with heartburn

    unexplained weight loss

    nausea or vomiting

    stomach pain

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking

    warfarin, clopifogrel or cilostazol (blood-thinning medicines)

    prescription antifungal or anti-yeast medications

    digozin (heart medicine)

    diazepam (anxiety medicine)

    tacrolimus or mycophenolate mofetil (immune system medicines)

    prescription antiretovirals (medicines for HIV infections)

    methotrexate (arthritis medicine)

  • STOP USE

    Stop use and ask a doctor if

    your heartburn continues or worsens

    you need to take this prodcut 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 OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health prefessional before use

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contract a Posion Control Center right away.

  • Directions

    adults 18 years of age and older

    this prodcut is to be used once a day (every 24 hours), every day for 14 days

    make 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 of more than 14 days unless directed by your doctor

    Repeated 14-Day Courses (if needed)

    you may repeart a 14-day course every 4 months

    do not take for more than 14 days or more often than every 4 mounths unless directed by a doctor

    children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be cuased by a serious condition.

  • Other Information

    each capsule contains: magnesium, 15 mg

    read the directions and warmings before use

    keep the carton. It contains important information.

    store at 20-25ºC (68 to 77ºF)

  • Inactive ingredients

    acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1, ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium odixe, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide

  • Questions or comments?

    call tool-free weekdays 8 AM to 10 PM EST at 1-888-375-3784

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-056-42

    Compare to the active ingredient in Nexium® 24 HR**

    Esomeprazole Magnesium

    Delayed-Release Capsules, USP

    20 mg*

    Acid Reducer

    42 Capsules

    Three 14-day Courses of Treatment

    Esomeprazole

  • INGREDIENTS AND APPEARANCE
    ESOMEPRAZOLE 
    esomeprazole capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-056
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Coloryellow (Gelatin capsule shell with light blue cap and dark blue body) Scoreno score
    ShapeOVAL (Capsule) Size9mm
    FlavorImprint Code RDY;327
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-056-423 in 1 CARTON11/01/2018
    1NDC:69618-056-1414 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20767311/01/2018
    Labeler - Reliable 1 Laboratories (079718111)