Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release

  • NDC Code(s): 59726-912-14
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 3, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredient (in each capsule)

    Esomeprazole 20 mg
    (*Each delayed-release capsule corresponds to 21.7 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

  • 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

    • warfarin, clopidogrel or cilostazol (blood-thinning medicines)
    • prescription antifungal or anti-yeast medicines
    • digoxin (heart medicine)
    • diazepam (anxiety medicine)
    • tacrolimus or mycophenolate mofetil (immune system medicines)
    • prescription antiretrovirals (medicines for HIV infection)
    • methotrexate (arthritis medicine)
  • 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 (1-800-222-1222) right away.

  • 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 us
    • keep the carton. It contains important information.
    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    gelatin, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion type C, mono-and di-glycerides, polysorbate 80, sodium lauryl sulfate, sugar spheres (contain sucrose, corn starch and purified water), talc, titanium dioxide, triethyl citrate.

    Each capsule is imprinted with blue pharmaceutical ink which contains butyl alcohol, dehydrated alcohol, FD&C Blue No 2 aluminum lake, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and having two parallel bands which contains FD&C Blue No 2 aluminum lake, gelatin and polysorbate 80

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

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

    24-hour

    esomeprazole magnesium

    delayed-release capsules

    USP, 20 mg*

    acid reducer

    treats frequent heartburn

    may take 1 to 4 days for full effect

    **This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Nexium® 24HR.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP OR BAND AROUND THE CENTER OF EACH CAPSULE IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY 11590

  • Package label

    Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

    READYinCASE 24-Hour esomeprazole magnesium

  • INGREDIENTS AND APPEARANCE
    ESOMEPRAZOLE MAGNESIUM 
    esomeprazole magnesium capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-912
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code AMNEAL1050
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-912-141 in 1 CARTON01/31/2020
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20971601/31/2020
    Labeler - P & L Development, LLC (800014821)