Calcium Gluconate: Product Information

CALCIUM GLUCONATE- calcium gluconate injection, solution
Phoenix

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.

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.

TAKE TIME OBSERVE LABEL DIRECTIONS

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

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

Store between 15°C-30°C (59°F-86°F).

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.

product label
(click image for full-size original)

CALCIUM GLUCONATE
calcium gluconate injection, solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:57319-630
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM GLUCONATE (CALCIUM CATION) CALCIUM GLUCONATE 23 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57319-630-07 500 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/04/2019
Labeler — Phoenix (150711039)
Registrant — Nova-Tech, Inc. (196078976)
Establishment
Name Address ID/FEI Operations
Nova-Tech, Inc. 196078976 manufacture, api manufacture

Revised: 11/2019 Phoenix

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