ReBalance Antiprotozoal: Product Information (Page 2 of 2)

HOW SUPPLIED:

Each mL of ReBalance Antiprotozoal Oral Suspension contains 250 mg of sulfadiazine ( as the sodium salt) and 12.5 mg pyrimethamine and is available in 946.4 mL (1 Quart) multiple dose child resistant, screw-capped bottles.

GENERAL INFORMATION:

For a Material Safety Data Sheet (MSDS) or to report Adverse Reactions, call Pegasus Laboratories, Inc. at 1-800-874-9764.

US patent No. 5,747,476; 6,255,308 and 6,448,252

Trademarks are property of Pegasus Laboratories, Inc.

Manufactured by:

Pegasus Laboratories, Inc.

An Employee Owned Company

Pensacola, FL 32514, USA

Insert Page 1
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Insert Page 2
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PRINCIPAL DISPLAY PANEL:

NDC #49427-247-11

ReBalance

Antiprotozoal Oral Suspension

(Sulfadiazine and Pyrimethamine)

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

Shake Well before Each Use

For oral Use in Horses Only

Keep Out of Reach of Children

Treatment for Equine Protozoal Myeloencephalitis (EPM) In Horses

NADA 141-240, Approved by FDA

PRN Pharmacal, Pegasus Laboratories, Inc.

NET CONTENTS: 946.4 mL (One Quart)

Bottle Label
(click image for full-size original)

REBALANCE ANTIPROTOZOAL
sulfadiazine and pyrimethamine suspension
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:49427-247
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFADIAZINE SODIUM (Sulfadiazine) Sulfadiazine 250 mg in 1 mL
Pyrimethamine (Pyrimethamine) Pyrimethamine 12.5 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor ALMOND Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49427-247-11 12 BOTTLE in 1 CARTON contains a BOTTLE
1 946 mL in 1 BOTTLE This package is contained within the CARTON (49427-247-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141240 11/05/2004
Labeler — Pegasus Laboratories, Inc (108454760)
Registrant — Pegasus Laboratories, Inc (108454760)
Establishment
Name Address ID/FEI Operations
Pegasus Laboratories, Inc 108454760 manufacture, analysis, label

Revised: 11/2019 Pegasus Laboratories, Inc

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