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NADA Number: 141-123

Proprietary Name GastroGard®
Sponsor Merial Ltd.
Sponsor Address 3239 Satellite Blvd.
Bldg. 500
Duluth, GA    30096-4640
USA
Ingredients Omeprazole
Species (Class) EQUIDS (Horse, foals 4 weeks and older, not for food)
EQUIDS (Horse, not for meat production)
Routes of Administration Per Os
Dosage Form Paste
Dispensing Status RX
Patent Number (Expiration Date) 4255431 (No Expiration Date)
5708017 (No Expiration Date)
Exclusivity No product using omeprazole as an active ingredient has been previously approved for use in horses in any other application.
Dosage Amount,
Indications
& Limitations

520.1615 Omeprazole.

Specifications: Each gram of oral paste contains 0.37 gram of omeprazole.

Conditions of use:

Horses

Amount: For treatment of gastric ulcers, 1.8 milligrams of omeprazole per pound of body weight (4 milligrams per kilogram) once daily for 4 weeks. For prevention of recurrence of gastric ulcers, 0.9 milligram of omeprazole per pound of body weight (2 milligrams per kilogram) once daily for at least an additional 4 weeks.

Indications: For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.

Limitations: Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.