Label: EQUALINE OMEPRAZOLE- omeprazole tablet, orally disintegrating, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 15, 2019

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

  • Active ingredient (in each tablet)

    Omeprazole 20 mg

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  • Purpose

    Acid reducer

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  • Use

    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
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  • Warnings

    Allergy alert: do not use if you are allergic to omeprazole

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  • 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 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.

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  • 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
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  • Ask a doctor or pharmacist before use if you are

    taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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  • 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
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • 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).

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  • Directions

    for adults 18 years of age and older
    this product is to be used once a day (every 24 hours), every day for 14 days
    it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

    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 Course (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.
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  • 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
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  • Inactive ingredients

    amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

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  • Questions or comments?

    1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST

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  • Package/Label Principal Display Panel

    compare to Prilosec OTC®

    MELTechTM

    Melts In Your Mouth

    24 HR

    omeprazole

    delayed release orally disintegrating tablets 20mg

    acid reducer

    melts in your mouth dissolves without water

    treats frequent heartburn!

    actual size

    14 tablets

    ONE 14-DAY COURSE OF TREATMENT

    MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

    strawberry flavor

    omeprazole image
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  • INGREDIENTS AND APPEARANCE
    EQUALINE OMEPRAZOLE 
    omeprazole tablet, orally disintegrating, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-634
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color RED (reddish) Score no score
    Shape ROUND Size 9mm
    Flavor STRAWBERRY Imprint Code 20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41163-634-74 14 in 1 CARTON 10/11/2018
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA209400 10/11/2018
    Labeler - Supervalu Inc (006961411)
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