Label: HEALTHY ACCENTS OMEPRAZOLE- omeprazole tablet, delayed release

  • NDC Code(s): 55316-915-01, 55316-915-03, 55316-915-30, 55316-915-55, view more
    55316-915-74
  • Packager: DZA Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/15

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

    Do not use

    if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. 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.
    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
    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 (immune system medicine)
    prescription antiretrovirals (medicines for HIV infection)

    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

    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)

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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) and protect from moisture
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  • 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

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  • Questions or comments?

    1-866-322-2439

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  • Principal Display Panel

    omeprazole

    delayed release tablets 20 mg

    acid reducer

    treats frequent heartburn!

    occurring 2 or more days a week

    14 tablets

    one 14-day course of treatment

    Omeprazole Carton Image
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  • INGREDIENTS AND APPEARANCE
    HEALTHY ACCENTS OMEPRAZOLE 
    omeprazole tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-915
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    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)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    Product Characteristics
    Color BROWN Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code 20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55316-915-55 3 in 1 CARTON
    1 1 in 1 CARTON
    1 14 in 1 BLISTER PACK
    2 NDC:55316-915-74 1 in 1 CARTON
    2 14 in 1 BLISTER PACK
    3 NDC:55316-915-30 2 in 1 CARTON
    3 1 in 1 CARTON
    3 14 in 1 BLISTER PACK
    4 NDC:55316-915-03 3 in 1 CARTON
    4 NDC:55316-915-01 14 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022032 03/03/2008
    Labeler - DZA Brands LLC (090322194)
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