DEXOLYTE- dextrose monohydrate, sorbitol, sodium lactate, sodium chloride, potassium chloride, magnesium chloride and calcium chloride injection, solution 
A & G Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Dexolyte Solution
Injection
Electrolytes-Dextrose

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION

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

INDICATIONS

For use in conditions associated with fluid and electrolyte loss, such as dehydration, shock, vomiting and diarrhea, particularly when an immediate source of energy is also indicated.

CONTRAINDICATIONS

Do not administer intraperitoneally to horses.

CAUTION

This product contains no preservatives. Use entire contents when first opened. Discard any unused solution.

DOSAGE AND ADMINISTRATION

Warm solution to body temperature and administer slowly (10 to 30 mL per minute) by intravenous or intraperitoneal injection, using strict aseptic procedures.

Adult Cattle and Horses- 1000 to 2000 mL
Calves, Ponies and Foals- 500 to 1000 mL
Adult Sheep and Swine- 500 to 1000 mL

These are suggested dosages. The actual amount and rate of fluid administration must be judged by the veterinarian in relation to the condition being treated and the clinical response of the animal, being careful to avoid overhydration.

COMPOSITION

Each 500 mL of sterile aqueous solution contains:
Dextrose.H2O...............................12.50 g
Sorbitol........................................12.50 g
Sodium Lactate..............................3.95 g
Sodium Chloride.............................2.40 g
Potassium Chloride.........................0.37 g
Magnesium Chloride.6H2O..............0.21 g
Calcium Chloride.2H2O...................0.19 g

Milliequivalents per liter

Cations
     Sodium..............................153 mEq/L
     Potassium.............................9 mEq/L
     Calcium.................................6 mEq/L
     Magnesium............................4 mEq/L

Anions
     Chloride.............................101 mEq/L
     Lactate................................71 mEq/L
Osmolarity (calc.) 602 mOsmol/L

Store between 15 degrees C - 30 degrees C (59 degrees F - 86 degrees F).

Manufactured by:
Nova-Tech, Inc.
Grand Island, NE 68801
Mfg. USA                 Iss. 06-09

NET CONTENTS: 500 mL

Manufactured for:
A and G Pharmaceuticals
Clarksburg, NJ 08510

TAKE TIME OBSERVE LABEL DIRECTIONS

image of label

DEXOLYTE 
electrolyte with dextrose injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:57699-804
Route of Administration INTRAVENOUS, INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose Monohydrate 12.50   in 500 mL
Sorbitol (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) Sorbitol 12.50   in 500 mL
Sodium Lactate (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT) Sodium Lactate 3.95   in 500 mL
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride 2.40   in 500 mL
Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) Potassium Chloride 0.37   in 500 mL
Magnesium Chloride (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) Magnesium Chloride 0.21   in 500 mL
Calcium Chloride (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) Calcium Chloride 0.19   in 500 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57699-804-50 500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/28/2013
Labeler - A & G Pharmaceuticals, Inc. (182147033)
Registrant - A & G Pharmaceuticals, Inc. (182147033)
Establishment
Name Address ID/FEI Business Operations
Nova-Tech, Inc. 196078976 manufacture

Revised: 3/2013
Document Id: 4ef97d24-e909-4c94-b738-7f9dfc1898db
Set id: e2dc5286-7271-4476-bd9a-c07f434dfe7d
Version: 2
Effective Time: 20130314
 
A & G Pharmaceuticals, Inc.