GASTROGARD - omeprazole paste 
Merial Limited

----------

GastroGard®
(omeprazole) Oral Paste for Equine Ulcers

Oral Paste for Horses and Foals

Caution

Description

Chemical Structure

How Supplied

Storage Conditions

Indications

Dosage Regimen

Directions For Use

Warning

Adverse Reactions

Precautions

Clinical Pharmacology

Efficacy

Safety

Reproductive Safety

For More Information

PRINCIPAL DISPLAY PANEL - Label

GastroGard®
(omeprazole)
NADA 141-123, Approved by FDA

Caution: Federal (USA) law restricts this drug to use by or on the
order of a licensed veterinarian.

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

Dosage Regimen: For oral use in horses only. For treatment of
gastric ulcers, GastroGard® (omeprazole) Paste should be administered
orally once-a-day for 4 weeks at the recommended dosage of 1.8 mg
omeprazole/lb body weight (4 mg/kg). For the prevention of
recurrence of gastric ulcers, continue treatment for at least an
additional 4 weeks by administering GastroGard (omeprazole) Paste at
the recommended daily maintenance dose of 0.9 mg/lb (2 mg/kg).

NET WT. 6.15 g (2.28 g of omeprazole)

READ PACKAGE INSERT FOR FURTHER
INSTRUCTIONS AND IMPORTANT INFORMATION.

Warning: Do not use in horses intended for human
consumption.
Keep this and all drugs out of the reach of children.

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

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

Made in Brazil

Customer Assistance: For more information, please call
1-888-637-4251. US Patent: 4255431 and 5708017

®GastroGard is a registered trademark of the AstraZeneca
Group of Companies. ©2009 Merial. All rights reserved.

1824/01 / 36611, Rev. 02-2009

LOT
EXP

PRINCIPAL DISPLAY PANEL - Label

PRINCIPAL DISPLAY PANEL - 7 Syrings Carton

GastroGard®
(omeprazole) Oral Paste for Equine Ulcers

Improves and Heals Gastric Ulcers

Prevents Gastric Ulcer Recurrence

Once-a-Day Dosing

NADA 141-123, Approved by FDA

Contains 7 Syringes
Individually Wrapped

Product 3661101

MERIAL

PRINCIPAL DISPLAY PANEL - 7 Syrings Carton

PRINCIPAL DISPLAY PANEL - 72 Syringe Shipping Label

READ PACKAGE INSERT FOR FURTHER INSTRUCTIONS
AND IMPORTANT INFORMATION.

GastroGard®
(omeprazole) Oral Paste for Equine Ulcers

For Treatment and Prevention of
Recurrence of Equine Gastric Ulcers

CAUTION: Federal (USA) law restricts this drug to use by or
on the order of a licensed veterinarian.

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

Lot No & Exp Date

Product 3661172

Marketed by:
Merial LLC,
Duluth, GA 30096-4640, U.S.A.
Made in Brazil
1829/01
36611
Rev. 02-2009

®GastroGard is a
registered trademark of
the AstraZeneca Group
of Companies.
©2009 Merial.
All rights reserved.

CONTENTS: 72 Syringes Individually Wrapped

MERIAL

PRINCIPAL DISPLAY PANEL - 72 Syringe Shipping Label

GASTROGARD 
omeprazole   paste
Product Information
Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 50604-3704
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
omeprazole (omeprazole) omeprazole 370 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color YELLOW Score     
Shape Size
Flavor CINNAMON Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 50604-3704-1 7 SYRINGE In 1 CARTON contains a SYRINGE, PLASTIC
1 6.15 g In 1 SYRINGE, PLASTIC This package is contained within the CARTON (50604-3704-1)
2 50604-3704-2 72 SYRINGE In 1 BOX contains a SYRINGE, PLASTIC
2 6.15 g In 1 SYRINGE, PLASTIC This package is contained within the BOX (50604-3704-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141123 03/16/1999

Labeler - Merial Limited (034393582)
Revised: 06/2009 Merial Limited