Mannitol by Covetrus / Nova-Tech, Inc MANNITOL injection

Mannitol by

Drug Labeling and Warnings

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

Drug Details [pdf]

Recommended Use:

For use as an osmotic diuretic in dogs. Mannitol is essentially inert metabolically. When given parenterally, it is freely filtered at the glomerulus which produces osmotic diuresis as more than 90% of the mannitol injected escapes reabsorption.

Each 100 mL Contains:

Mannitol USP...................................20 g

Water for Injection...........................q.s.

This solution contains 1098 mOsmols/Liter

Dosage and administration:

The usual canine dosage administered intravenously is 1.5 - 2.0 g per kg body weight given over a 30 minute period. This is approximately 3.4-4.5 mL/lb of body weight.

Note:

Crystals of mannitol may form in a 20% saturated solution of mannitol. Dissolve the crystals by warming in hot water or autoclaving for 15 minutes. Cool to body temperature before administering. This is a single dose vial that contains no preservatives. Use entire contents when first opened.

STORAGE AND HANDLING

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

SPL UNCLASSIFIED SECTION

NDC: 11695-1254-1

Net contents: 100 mL (3.4 fl oz)

Lot No.

Exp. Date

Reorder #002469

Questions?

(855) 724-3461

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

Made in the USA

AH-002469-02

RMS-92-1192

L919-1119

REV: 1119

Caution:

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

FOR ANIMAL USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MANNITOL 
mannitol injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-1254
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)	MANNITOL	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-1254-1	100 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/16/2020

Labeler - Covetrus (603750329)

Registrant - Nova-Tech, Inc (196078976)

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