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.

----------

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.

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

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.

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.

CONTRAINDICATIONS

Do not administer intraperitoneally to horses.

CONTAINS

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

STORAGE

Store between 15 degree C - 30 degree C (59 degree F - 86 degree F)

image of container label

DEXOLYTE 
electrolyte with dextrose injection, solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57699-804
Route of AdministrationINTRAVENOUS, INTRAPERITONEALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextrose Monohydrate (ANHYDROUS DEXTROSE) Dextrose Monohydrate12.50   in 500 mL
Sorbitol (SORBITOL) Sorbitol12.50   in 500 mL
Sodium Lactate (LACTIC ACID) Sodium Lactate3.95   in 500 mL
Sodium Chloride (SODIUM CATION) Sodium Chloride2.40   in 500 mL
Potassium Chloride (POTASSIUM CATION) Potassium Chloride0.37   in 500 mL
Magnesium Chloride (MAGNESIUM CATION) Magnesium Chloride0.21   in 500 mL
Calcium Chloride (CALCIUM CATION) Calcium Chloride0.19   in 500 mL
Packaging
#Item CodePackage Description
1NDC:57699-804-50500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/28/2013
Labeler - A & G Pharmaceuticals, Inc. (182147033)
Registrant - A & G Pharmaceuticals, Inc. (182147033)
Establishment
NameAddressID/FEIBusiness Operations
Nova-Tech, Inc.196078976manufacture
Establishment
NameAddressID/FEIBusiness Operations
Morton Salt, Inc137658043api manufacture

Revised: 01/2013
 
A & G Pharmaceuticals, Inc.