Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release

  • NDC Code(s): 69238-1050-1, 69238-1050-2, 69238-1050-3, 69238-1050-4, view more
    69238-1050-5, 69238-1050-8, 69238-1050-9
  • Packager: Amneal Pharmaceuticals NY LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 13, 2020

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

  • Drug Facts

    Active ingredient

    (in each capsule)

    Purpose

    Esomeprazole 20 mg

    Acid reducer

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

  • 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 the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center 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 use
    • keep the carton. It contains important information.
    • store at 20° to 25°C (68° to 77°F)
    • Tamper Evident: Do not use if printed safety seal under cap or band around the center of each capsule is broken or missing.
  • Inactive ingredients

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

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

  • Questions or comments?

    Call toll-free 1-877-835-5472

    Mon – Fri 9AM – 5PM EST.

    Made in India
    For most recent product information, visit www.amneal.com

  • PURPOSE

  • Principal Display Panel

    NDC 69238-1050-4

    Esomeprazole Magnesium Delayed-Release Capsules, USP/Acid Reducer (OTC)

    20 mg

    14 Capsules (Container Label)

    Amneal Pharmaceuticals LLC

     12

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    sd

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    NDC 69238-1050-3

    Esomeprazole Magnesium Delayed-Release Capsules, USP /Acid Reducer (OTC)

    20 mg

    42 Capsules (Carton Pack)

    Amneal Pharmaceuticals LLC

    uy
  • INGREDIENTS AND APPEARANCE
    ESOMEPRAZOLE MAGNESIUM 
    esomeprazole magnesium capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69238-1050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    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:69238-1050-11 in 1 BLISTER PACK06/05/2019
    1NDC:69238-1050-414 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69238-1050-92 in 1 BLISTER PACK06/05/2019
    2NDC:69238-1050-414 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69238-1050-83 in 1 BLISTER PACK06/05/2019
    3NDC:69238-1050-414 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69238-1050-51 in 1 CARTON06/05/2019
    4NDC:69238-1050-414 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69238-1050-22 in 1 CARTON06/05/2019
    5NDC:69238-1050-414 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:69238-1050-33 in 1 CARTON06/05/2019
    6NDC:69238-1050-414 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20971606/05/2019
    Labeler - Amneal Pharmaceuticals NY LLC (123797875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amneal Pharmaceuticals Private Limited915076126ANALYSIS(69238-1050) , LABEL(69238-1050) , MANUFACTURE(69238-1050) , PACK(69238-1050)