Dextrose 50% Solution: Product Information

DEXTROSE 50% SOLUTION- dextrose monohydrate injection, solution
Nova-Tech, 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.

Dosage And Administration:

The usual dose is 50 mL per 100 lbs of body weight. It should be administered intravenously only. Dosage may be repeated in 8 to 10 hours or on successive days if necessary.

Caution:

It should be warmed to body temperature and administered slowly. This product contains no presevatives. Do not use if solution is not clear. Entire contents should be used upon opening. Discard any unused portion.

FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN

Active Ingredients

Dextrose H2 O………………………50% w/v

Water for Injection……………….q.s.

Indications:

Dextrose 50% Solution is indicated for use as an aid in the treatment of uncomplicated primary ketosis in cattle.

Store between 15°C-30°C (59°F-86°F).

TAKE TIME OBSERVE LABEL DIRECTIONS

Manufactured by:

Nova-Tech, Inc.

Grand Island, NE 68801 USA

18-801

RMS 92-325

NDC# 65207-801-50

Nova-Tech® Animal Health

Dextrose 50% Solution

Sterile Solution

Net Contents:

500 mL (16.91 fl oz)

Assembled in USA

Lot No. Exp. Date

Container label
(click image for full-size original)
Container label
(click image for full-size original)

DEXTROSE 50% SOLUTION
dextrose injection, solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:65207-801
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 50 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65207-801-50 500 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/13/2020
Labeler — Nova-Tech, Inc. (196078976)
Registrant — Nova-Tech, Inc. (196078976)
Establishment
Name Address ID/FEI Operations
Nova-Tech, Inc. 196078976 manufacture, api manufacture

Revised: 03/2020 Nova-Tech, Inc.

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