FAMILY WELLNESS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [FAMILY DOLLAR SERVICES INC]

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FAMILY WELLNESS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [FAMILY DOLLAR SERVICES INC]
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NDC 55319-915-30, 55319-915-74
Set ID 0f195e96-4acb-48fa-b1f7-d6504601fe27
Category HUMAN OTC DRUG LABEL
Packager Family Dollar Services Inc
Generic Name
Product Class
Product Number
Application Number NDA022032
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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 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:

    •
    warfarin, clopidogrel or cilostazol (blood-thinning medicines)
    •
    prescription antifungal or anti-yeast medicines
    •
    diazepam (anxiety medicine)
    •
    digoxin (heart medicine)
    •
    tacrolimus or mycophenolate mofetil (immune system medicines)
    •
    prescription antiretrovirals (medicines for HIV infection)
    •
    methotrexate (arthritis medicine)

    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

    •
    swallow 1 tablet with a glass of water before eating in the morning
    •
    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
    •
    swallow whole. Do not chew or crush tablets

    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. 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) and protect from moisture
  • Inactive ingredients

    carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    COMPARE TO PRILOSEC OTC®

    100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

    Omeprazole

    Delayed Release Tablets 20 mg

    Acid Reducer

    Treats Frequent Heartburn!

    Occurring 2 Or More Days A Week

    ONE 14-DAY COURSE OF TREATMENT

    14 TABLETS

    ACTUAL SIZE

    OTC network

    omeprazole-image
  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS OMEPRAZOLE 
    omeprazole tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-915
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-915-7414 in 1 CARTON08/14/2013
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:55319-915-302 in 1 CARTON08/14/2013
    214 in 1 CARTON
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02203208/14/2013
    Labeler - Family Dollar Services Inc (024472631)
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