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OMESEC (Corporacion Infarmasa)

Available Formats

Dosage Form Package Information Links
CAPSULE, DELAYED RELEASE 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (16853-1308-4) Label Information
CAPSULE, DELAYED RELEASE 28 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (16853-1308-2) Label Information
CAPSULE, DELAYED RELEASE 42 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (16853-1308-3) Label Information
CAPSULE, DELAYED RELEASE 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (16853-1308-1) Label Information

Complete OMESEC Information

  • ASK 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 DOCTOR/PHARMACIST


    Ask a doctor or pharmacist before use if you are taking:

    • Warfarin (blood-thinning medicine)
    • Prescription antifungal or anti-yeast medicines
    • Diazepam (anxiety medicine)
    • Digoxin (heart medicine)
    • Tacrolimus (immune system medicine)
    • Atazanavir (medicine for HIV infection)

  • DO NOT USE

    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.

    Do not use if capsule blister unit is open or torn

  • 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)



  • PREGNANCY OR BREAST FEEDING


    If pregnant or breast-feeding, ask a health professional before use


  • STOP USE

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

    Stop use and ask a Doctor if:

        * Your heartburn continues or worsens
        * You need to take his product for more than 14 days
        * You need to take more than 1 course of treatment every 4 months

    Do not use if capsule blister unit is open or torn


  • PURPOSE


    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.



  • QUESTIONS

    If you have questions of a medical nature, please contact your pharmacist, doctor or health care proffesional



  • STORAGE AND HANDLING

    • Read the directions, warnings and package insert before use
    • Keep the carton and package insert. They contain important information
    • Store at 20ºC to 25ºC ( 68ºF to 77ºF)
    • Keep product out of high heat and humidity
    • Protect product from moisture

  • DOSAGE & ADMINISTRATION

    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, although some people get complete relief of symptoms within 24 hours


    14-Day Course of Treatment

    • Swallow 1 capsule with a glass of water before eating in the morning
    • Take every day for 14 days
    • Do not take more than 1 capsule a day
    • Do not chew or crush the capsule
    • Do not crush capsules in food
    • Do not use for more than 14 days unless directed by your doctor
    Repeated 14-Day Courses (if needed)

    • You may repeat a 14-day course every 4 months
    • Do not take more than 14 days or more often than every 4 month unless directed by a doctor
    Children under 18 years of age: ask a doctor

    Other Information
    • Read the directions, warnings and package insert before use

  • INACTIVE INGREDIENT

    Diethyl Phthalate, Sodium Lauryl Sulfate, Disodium Phosphate, Hydroxypropyl Cellulose, Lactose, Hypromellose, Corn Starch, Hypromellose Phthalate, Sucrose


  • PRINCIPAL DISPLAY PANEL

    Omesec Caps
    Carton Label

  • INGREDIENTS AND APPEARANCE
    OMESEC 
    omeprazole capsule, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16853-1308
    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
    DIETHYL PHTHALATE (UNII: UF064M00AF) 0.144 mg
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 0.432 mg
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) 0.816 mg
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) 6.24 mg
    LACTOSE (UNII: J2B2A4N98G) 8.16 mg
    HYPROMELLOSE (UNII: 3NXW29V3WO) 11.81 mg
    STARCH, CORN (UNII: O8232NY3SJ) 24.96 mg
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5) 25.18 mg
    SUCROSE (UNII: C151H8M554) 142.26 mg
    Product Characteristics
    Color red (Red Capsule) Score score with uneven pieces
    Shape CAPSULE (Delayed Release Capsules) Size 17mm
    Flavor Imprint Code None
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16853-1308-2 28 in 1 BLISTER PACK
    2 NDC:16853-1308-1 14 in 1 BLISTER PACK
    3 NDC:16853-1308-3 42 in 1 BLISTER PACK
    4 NDC:16853-1308-4 2 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075410 02/28/2010
    Labeler - Corporacion Infarmasa (934098294)
    Establishment
    Name Address ID/FEI Business Operations
    Corporacion Infarmasa 934098294 manufacture