Animal NDC 57319-630-07 Calcium Gluconate

Animal Product Information

Field Name Field Value
Animal NDC Code 57319-630-07
Proprietary Name Calcium Gluconate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Calcium Gluconate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Phoenix
Product Type Otc Animal Drug
Usage Information
    For use in cattle as an aid in treating uncomplicated milk fever (parturient paresis).
Active Ingredient(s)
  • Calcium Gluconate
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Calcium Gluconate Images

Calcium Gluconate Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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


Otc - 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.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.