CALCIUM GLUCONATE injection, solution

Calcium Gluconate by

Drug Labeling and Warnings

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

Drug Details [pdf]

INDICATIONS:

For use in cattle as an aid in treating uncomplicated milk fever (parturient paresis).

DOSAGE AND ADMINISTRATION:

For intravenous administrion only.

Cattle: 250 to 500 mL

Doasage may be repeated at 8 to 12 hour intervals if required.

PRECAUTIONS

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS

Manufactured by

Nova-Tech Inc.

Grand Island, NE 68801

RMS 92-593

18-802-50

Iss. 10-19

Lot No.

Exp. Date

NDC: 57319-630-07

Calcium Gluconate 23%

Sterile - Preservative Free

Next Contents: 500 mL

PhoenixTM

Manufactured for:

Clipper Distributing Company, LLC 

St. Joseph, MO 64507

Trademarks are property

of Clipper Distributing

Company, LLC

ACTIVE INGREDIENT

Each 500 mL CONTAINS:

Active Ingredients

Calcium Gluconate...................23% w/v

 (provides 10.71 g of Calcium * per 500 mL)

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

Inactive Ingredients

Boric Acid
  (as a solubilizing agent)...........3.5 grams
Electrolytes per 1000 mL:

Calcium 1069 mEq;
Hypertonic                              pH 2.5-4.5 

STORAGE AND HANDLING

Store between 15°C-30°C (59°F-86°F).

GENERAL PRECAUTIONS

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Caution:

Solution should be warmed to body temperature and admisinstered slowly. Entire contents should be used upon entering, as this product contains no preservative. Discard any unused portion. Do no use if solution is cloudy or contains precipitate.

Note: 

Monitor animal's condition closely. Re-treatment may be necessary. If there is no noticeable improvement within 24 hours following treatment, consult your veterinarian. Aseptic precautions should be observed.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALCIUM GLUCONATE 
calcium gluconate injection, solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 57319-630
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM GLUCONATE (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM GLUCONATE	23 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57319-630-07	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/04/2019

Labeler - Phoenix (150711039)

Registrant - Nova-Tech, Inc. (196078976)

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