GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [L. PERRIGO COMPANY]

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  • GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [L. PERRIGO COMPANY]

GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [L. PERRIGO COMPANY]
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NDC 0113-0520-55, 0113-0520-74
Set ID dcd93796-8904-415d-a379-c4ea590cf544
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number NDA209400
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  • Active ingredient (in each tablet)

    Omeprazole 20 mg

  • Purpose

    Acid reducer

  • 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
  • Warnings

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

  • 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.

  • 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

    •
    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.
  • 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
  • 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

  • Questions or comments?

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

  • Package/Label Principal Display Panel

    MELTech™

    Melts In Your Mouth

    Treats Frequent Heartburn!

    24 HR

    Omeprazole

    Delayed Release Orally Disintegrating Tablets 20 mg

    Actual Size

    Strawberry Flavor

    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

    Compare to Prilosec OTC®

    omeprazole image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE OMEPRAZOLE 
    omeprazole tablet, orally disintegrating, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorRED (reddish) Scoreno score
    ShapeROUNDSize9mm
    FlavorSTRAWBERRYImprint Code 20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0520-553 in 1 CARTON06/21/2018
    114 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0113-0520-7414 in 1 CARTON06/19/2018
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20940006/19/2018
    Labeler - L. Perrigo Company (006013346)
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