Label: ESOMEPRAZOLE tablet, orally disintegrating, delayed release

  • NDC Code(s): 64239-112-02, 64239-112-03, 64239-112-04, 64239-112-05, view more
    64239-112-07, 64239-112-08, 64239-112-09, 64239-112-10
  • Packager: Dexcel Pharma Technologies Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 14, 2022

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  • Drug Facts

    Active ingredient (in each tablet)

    Esomeprazole 20 mg

    (Each delayed-release tablet corresponds to 22.3 mg

    esomeprazole magnesium trihydrate) 

  • 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

    • Esomeprazole may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash

    If an allergic reaction occurs, stop use and seek medical help right away.

    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 (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

    • take 1 tablet before eating in the morning
    • do not crush or chew tablets
    • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
    • take every day for 14 days
    • do not take more than 1 tablet a day
    • do not use for more than 14 days unless directed by your doctor
    • do not take this medicine with alcohol

    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 SAFETY INFORMATION

    Other information

    • read the directions and warnings before use
    • keep the carton. It contains important information
    • store at 20-25°C (68-77°F); keep product out of high heat and moisture
    • store in the original package
  • Inactive ingredients

    acetone, alcohol, amino methacrylate copolymer, ascorbic acid, benzyl alcohol, cetyl alcohol, colloidal silicon dioxide, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, flavor, hypromellose, hypromellose phthalate, isopropyl alcohol, mannitol, microcrystalline cellulose, modified starch, polysorbate 80, pregelatinized starch, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments? 1-800-XXX-XXXX:

    Weekdays XXX AM to XXX PM EST

  • Tips for Managing Heartburn

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

    NDC 64239-112-02

    MELTechTM

    Melts in Your Mouth

    Compare to the active ingredient in Nexium® 24HR*

    Treats Frequent Heartburn! 24HR

    Esomeprazole

    Delayed Release

    Orally Disintegrating Tablets 20 mg

    Acid Reducer

    Melts in your mouth

    Dissolves without water

    14 TABLETS

    One 14-day course of treatment

    May take 1 to 4 days for full effect

    Wildberry Flavor

    Actual size

    image description

  • PRINCIPAL DISPLAY PANEL

    NDC 64239-112-03

    MELTechTM

    Melts in Your Mouth

    Compare to the active ingredient in Nexium® 24HR*

    Treats Frequent Heartburn! 24HR

    Esomeprazole

    Delayed Release

    Orally Disintegrating Tablets 20 mg

    Acid Reducer

    Melts in your mouth

    Dissolves without water

    28 TABLETS

    Two 14-day courses of treatment

    May take 1 to 4 days for full effect

    Wildberry Flavor

    Actual size

    image description

  • PRINCIPAL DISPLAY PANEL

    NDC 64239-112-04

    MELTechTM

    Melts in Your Mouth

    Compare to the active ingredient in Nexium® 24HR*

    Treats Frequent Heartburn! 24HR

    Esomeprazole

    Delayed Release

    Orally Disintegrating Tablets 20 mg

    Acid Reducer

    Melts in your mouth

    Dissolves without water

    42 TABLETS

    Three 14-day courses of treatment

    May take 1 to 4 days for full effect

    Wildberry Flavor

    Actual size

    image description

  • PRINCIPAL DISPLAY PANEL

    NDC 64239-112-05

    MELTechTM

    Melts in Your Mouth 

    FREE SAMPLE

    Compare to the active ingredient in Nexium® 24HR*

    Treats Frequent Heartburn! 24HR

    Esomeprazole

    Delayed Release

    Orally Disintegrating Tablets 20 mg

    Acid Reducer

    Melts in your mouth

    Dissolves without water

    2 TABLETS

    First 2 doses of a 14-day course of treatment

    May take 1 to 4 days for full effect

    Wildberry Flavor

    Actual size

    image description

  • PRINCIPAL DISPLAY PANEL

    NDC 64239-112-07

    MELTechTM

    Melts in Your Mouth 

    Compare to the active ingredient in Nexium® 24HR*

    Treats Frequent Heartburn! 24HR

    Esomeprazole

    Delayed Release

    Orally Disintegrating Tablets 20 mg

    Acid Reducer

    Melts in your mouth

    Dissolves without water

    14 TABLETS

    One 14-day course of treatment

    May take 1 to 4 days for full effect

    Wildberry Flavor

    Actual size

    image description

  • PRINCIPAL DISPLAY PANEL

    NDC 64239-112-08

    MELTechTM

    Melts in Your Mouth 

    Compare to the active ingredient in Nexium® 24HR*

    Treats Frequent Heartburn! 24HR

    Esomeprazole

    Delayed Release

    Orally Disintegrating Tablets 20 mg

    Acid Reducer

    Melts in your mouth

    Dissolves without water

    28 TABLETS

    Two 14-day courses of treatment

    May take 1 to 4 days for full effect

    Wildberry Flavor

    Actual size

    image description

  • PRINCIPAL DISPLAY PANEL

    NDC 64239-112-09

    MELTechTM

    Melts in Your Mouth 

    Compare to the active ingredient in Nexium® 24HR*

    Treats Frequent Heartburn! 24HR

    Esomeprazole

    Delayed Release

    Orally Disintegrating Tablets 20 mg

    Acid Reducer

    Melts in your mouth

    Dissolves without water

    42 TABLETS

    Three 14-day courses of treatment

    May take 1 to 4 days for full effect

    Wildberry Flavor

    Actual size

    image description

  • PRINCIPAL DISPLAY PANEL

    NDC 64239-112-10

    MELTechTM

    Melts in Your Mouth 

    FREE SAMPLE

    Compare to the active ingredient in Nexium® 24HR*

    Treats Frequent Heartburn! 24HR

    Esomeprazole

    Delayed Release

    Orally Disintegrating Tablets 20 mg

    Acid Reducer

    Melts in your mouth

    Dissolves without water

    2 TABLETS

    First 2 doses of a 14-day course of treatment

    May take 1 to 4 days for full effect

    Wildberry Flavor

    Actual size

    image description

  • INGREDIENTS AND APPEARANCE
    ESOMEPRAZOLE 
    esomeprazole tablet, orally disintegrating, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64239-112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Esomeprazole (UNII: N3PA6559FT) (ESOMEPRAZOLE - UNII:N3PA6559FT) Esomeprazole20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize11mm
    FlavorRASPBERRY (Wildberry) Imprint Code 20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64239-112-072 in 1 CARTON04/12/2024
    17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:64239-112-082 in 1 CARTON04/12/2024
    22 in 1 CARTON
    27 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:64239-112-093 in 1 CARTON04/12/2024
    32 in 1 CARTON
    37 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:64239-112-101 in 1 CARTON04/12/2024
    42 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:64239-112-022 in 1 CARTON04/12/2024
    57 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:64239-112-032 in 1 CARTON04/12/2024
    62 in 1 CARTON
    67 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:64239-112-043 in 1 CARTON04/12/2024
    72 in 1 CARTON
    77 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:64239-112-051 in 1 CARTON04/12/2024
    82 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21427804/12/2024
    Labeler - Dexcel Pharma Technologies Ltd (533597626)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dexcel Pharma Technologies Ltd533597626manufacture(64239-112)
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