Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release

  • NDC Code(s): 69230-320-14, 69230-320-31, 69230-320-32, 69230-320-33
  • Packager: Camber Consumer Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 8, 2020

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

  • ACTIVE INGREDIENT (in each capsule)

    Esomeprazole 20 mg
    (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate 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


  • 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

    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)
  • INACTIVE INGREDIENTS

    Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide, polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

  • QUESTIONS OR COMMENTS?

    call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418.


    Distributed by:
    Camber Consumer Care, Inc.

    Piscataway, NJ 08854, USA.

  • PRINCIPAL DISPLAY PANEL

    Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton


    carton

  • INGREDIENTS AND APPEARANCE
    ESOMEPRAZOLE MAGNESIUM 
    esomeprazole magnesium capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: MB5IUD6JUA)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    AMMONIA (UNII: 5138Q19F1X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    Product Characteristics
    ColorWHITE (white opaque cap) , BLUE (blue opaque body) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code H;E4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69230-320-311 in 1 CARTON06/02/2020
    1NDC:69230-320-1414 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69230-320-322 in 1 CARTON06/02/2020
    2NDC:69230-320-1414 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69230-320-333 in 1 CARTON06/02/2020
    3NDC:69230-320-1414 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21250706/02/2020
    Labeler - Camber Consumer Care (079539968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hetero Labs Limited Unit III676162024ANALYSIS(69230-320) , MANUFACTURE(69230-320)