ULCERGARD (OMEPRAZOLE) PASTE [MERIAL, INC.]

ULCERGARD (OMEPRAZOLE) PASTE [MERIAL, INC.]
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NDC 50604-9719-1, 50604-9719-2
Set ID 3d79106e-6a9d-4690-968d-d92c2de825c8
Category OTC ANIMAL DRUG LABEL
Packager Merial, Inc.
Generic Name
Product Class
Product Number
Application Number NADA141227
  • PREVENTS STOMACH ULCERS BY REDUCING ACID PRODUCTION

    Stomach ulcers are more common in horses than once believed. Studies have demonstrated stomach ulcers in over 90% of racehorses and 60% of performance horses in various disciplines. Horses secrete acid in their stomach 24 hours a day. Horses on grass pasture or eating large quantities of roughage infrequently develop stomach ulcers. Horses without continual access to roughage or in rigorous training are at greater risk of stomach ulceration due to the effects of acid on the stomach lining. The additional stresses of traveling, competition, stall confinement, and strenuous exercise can also contribute to the development of stomach ulcers in horses.

    ULCERGARD works to prevent stomach ulcers in horses. The active ingredient in ULCERGARD, omeprazole has been extensively tested for safety and effectiveness. It works by reducing the production of acid in the horse's stomach. To help horses maintain optimal gastric health, it is recommended that ULCERGARD be administered during stressful events or activities that may induce stomach ulcers. Such conditions may include: training, racing, showing, traveling, stall confinement, and competition.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE: Each syringe contains 4 individual daily doses for horses weighing 600-1200 lbs. Please refer to the following dosage chart for help in determining the correct dose for your horse.

    ULCERGARD® DOSAGE CHART
    HORSE WEIGHTDOSE*
    *
    Duration of 8 or 28 days

    Less than 600 lbs.

    Consult a veterinarian

    600-1,200 lbs.

    1 dose per day

    over 1,200 lbs.

    2 doses once per day

    SYRINGE INSTRUCTIONS:

    1.
    To set the syringe plunger, while holding plunger, turn the knurled ring on the plunger ¼ turn to the left and slide the knurled ring along the plunger shaft so that the side nearest the barrel is at the appropriate daily dose marking, aligning the arrow on the plunger with the notch on the ring, as shown in the pictogram.
    2.
    Lock the ring in place by making ¼ turn to the right. Ensure it is locked (it should no longer slide).
    3.
    Make sure horse's mouth contains no feed before administration.
    4.
    Remove syringe tip cover.
    5.
    Insert syringe into the corner of the horse's mouth.
    6.
    Depress the plunger until it stops at the dose ring.
    FigureFigure
    Figure
    The entire dose should be deposited on the back of the tongue or deep in the cheek pouch.
    Horses should be observed briefly to assure no part of the dose is lost or rejected.
    If any of the dose is lost, re-dosing is recommended.
    Replace cap if any unused doses remain in the syringe.
    Figure
  • SPL UNCLASSIFIED SECTION

    ACTIVE INGREDIENT: omeprazole 2.28 g.

  • VETERINARY INDICATIONS

    USES: For the prevention of gastric ulcers in horses.

  • DOSAGE & ADMINISTRATION

    DOSAGE: The minimum recommended dosage is 1 mg/kg per day (0.45 mg/lb) or 1/4 syringe. When given once daily during the stressful period, ULCERGARD has been shown to effectively prevent stomach ulcers in horses. This effect was tested in horses exposed to stressful conditions for either 8 or 28 days.

  • WARNINGS

    WARNING: Not for use in humans. Keep this and all medications out of the reach of children. In case of ingestion by humans, contact a physician. Do not use in horses intended for human consumption. To obtain product information call 1-877-MERIAL-E.

  • INFORMATION FOR HORSE OWNERS:

    ULCERGARD is intended for use in healthy horses. If you notice any signs of illness prior to or during the use of this product, consult your veterinarian for appropriate diagnosis and treatment recommendations.
    ULCERGARD may be used in horses that weigh at least 600 lbs. The effectiveness of ULCERGARD in the prevention of gastric ulcers in foals and weanlings has not been evaluated.
    ULCERGARD may be used safely in breeding stallions. Safety in pregnant mares has not been determined.
    Once daily administration of ULCERGARD is recommended in horses exposed to stressful conditions which may include: training, racing, showing, traveling, stall confinement, and competition.
    ULCERGARD is intended for use only in the prevention of gastric ulcers in healthy horses. Clinical signs of gastric ulcers may include: decreased appetite, recurrent colic, intermittent loose stools or diarrhea, poor hair coat, poor body condition or poor performance. These signs may also be associated with other diseases as well as existing gastric ulcers. If your horse is exhibiting one or more of these signs, consult your veterinarian for diagnosis and treatment.
  • STORAGE AND HANDLING

    STORAGE INFORMATION: Store at 68°F-77°F (20-25°C). Excursions between 59°F-86°F (15-30°C) are permitted.

  • CUSTOMER ASSISTANCE AND WEB SITE:

    For more information, please call 1-877-MERIAL-E or visit our web site: www.ULCERGARD.com.

    ®ULCERGARD is a registered trademark of Merial Inc.

    All rights reserved.

    ©2015 Merial, Inc.

    603003511

    Rev. 4-2015

    Marketed by: Merial, Inc,
    Duluth, GA 30096-4640,
    U.S.A.

    Made in Brazil

  • PRINCIPAL DISPLAY PANEL - 6 Syringe Carton

    For the prevention of gastric ulcers in horses.
    ONCE-A-DAY DOSING WITH A WELL-ACCEPTED PASTE

    ULCERGARD®
    (omeprazole) Oral Paste for Horses

    Contains 6 Syringes (4 Doses Each)
    Net Wt. Contains 6 x 0.22 oz (6.15 g)
    Oral Syringes

    NADA 141-227, Approved by FDA

    CONTAINS 24 DOSES

    MERIAL

    Make every dose count.
    See New Instructions.

    PRINCIPAL DISPLAY PANEL - 6 Syringe Carton
  • INGREDIENTS AND APPEARANCE
    ULCERGARD 
    omeprazole paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50604-9719
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    omeprazole (UNII: KG60484QX9) (omeprazole - UNII:KG60484QX9) omeprazole370 mg  in 1 g
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorCINNAMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50604-9719-11 in 1 CARTON
    16.15 g in 1 SYRINGE, PLASTIC
    2NDC:50604-9719-26 in 1 CARTON
    26.15 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14122702/18/2004
    Labeler - Merial, Inc. (799641006)

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