DEXALYTE SOLUTION injection, solution

Dexalyte Solution by

Drug Labeling and Warnings

Dexalyte Solution by is a Animal medication manufactured, distributed, or labeled by Vedco, Nova-Tech, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 intraperi-
toneally 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 mLCalves, Ponies, and Foals - 500 to 1000 mLAdult Sheep and Swine - 500 to 1000 mL

These are suggested dosages. The actual amountand 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. 

PRECAUTIONS

TAKE TIME OBSERVE LABEL DIRECTIONS

VETERINARY INDICATIONS

FOR ANIMAL USE ONLY

WARNINGS AND PRECAUTIONS

KEEP OUT OF REACH OF CHILDREN

CAUTION:

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

COMPOSITION:

Each 500 mL of sterile
aqueous solution contains:
Dextrose  H2O.........................12.50 gSorbitol...................................12.50 gSodium Lactate.........................3.95 gSodium Chloride........................2.40 gPotassium Chloride....................0.37 gMagnesium Chloride 6H2O.........0.21 gCalcium Chloride 2H2O..............0.19 g

Milliequivalents per literCationsSodium...................................153 mEq/LPotassium..................................9 mEq/LCalcium.....................................6 mEq/LMagnesium................................4 mEq/LAnionsChloride..................................101 mEq/LLactate.....................................71 mEq/LOsmolarity (calc.)  602 mOsmol/L

STORAGE AND HANDLING

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

INFORMATION FOR OWNERS/CAREGIVERS

18-804-60 

Rev. 01-07

Distributed By
VEDCO, INC.
St. Joseph, MO 64507

NDC: 50989-643-17

NET CONTENTS: 1000 mL

Lot No.

Exp. Date

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEXALYTE SOLUTION 
dexalyte solution injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 50989-643
Route of Administration	INTRAVENOUS, INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK)	Dextrose Monohydrate	12.50 g  in 500 mL
Sorbitol (UNII: 506T60A25R) (Sorbitol - UNII:506T60A25R)	Sorbitol	12.50 g  in 500 mL
Sodium Lactate (UNII: TU7HW0W0QT) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Lactate	3.95 g  in 500 mL
Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698)	Sodium Chloride	2.40 g  in 500 mL
Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152)	Potassium Chloride	0.37 g  in 500 mL
Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838)	Magnesium Chloride	0.21 g  in 500 mL
Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB)	Calcium Chloride	0.19 g  in 500 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50989-643-17	1000 mL in 1 BOTTLE, PLASTIC
2	NDC: 50989-643-16	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/12/2018

Labeler - Vedco (021634266)

Registrant - Vedco (021634266)

Establishment
Name	Address	ID/FEI	Business Operations
Nova-Tech, Inc.		196078976	manufacture, api manufacture