CALCICURE injection, solution

CalciCure by

Drug Labeling and Warnings

CalciCure by is a Animal medication manufactured, distributed, or labeled by Vedco, Nova-Tech, Inc., Zhejiang Ruibang Laboratories, Jost Chemical Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

Parenteral Solution

FOR ANIMAL USE ONLY

Indications:

For intravenous use in milk fever,
and in calcium, phosphorus, magnesium and
glucose deficiency in animals.

Note:

Intravenous administration is always
preferable. If used subcutaneously, always
distribute dose in several places and massage
to facilitate absorption.

Dosage:

Cattle, 500 mL. For milk fever prophy-
laxis, give 200-500 mL at time of calving.
Horses, 250-500 mL; Sheep, 50-125 mL.
Repeat in 2 to 6 hours if needed. This product
contains no preservative. Unused portion
remaining in bottle must be discarded.

Caution:

Large doses administered intra-
venously may have toxic action on heart if
the blood level of calcium is raised
excessively. Doses should be carefully
regulated according to severitity of hypo-
calcemia and injected slowly so that
administration may be stopped if toxic
action becomes evident.

WARNINGS AND PRECAUTIONS

KEEP OUT OF REACH OF CHILDREN

CAUTION:

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

CONTAINS:

Calcium borogluconate, dextrose, magnesium
borogluconate, calcium hypophosphite and
base.
Total calcium chemically equivalent to
calcium borogluconate ..................... 26.0% w/v
Dextrose  H2O .............................. 15.0% w/v
Magnesium borogluconate ................. 6.0% w/v
Total phosphorus in amounts
chemically equivalent to elemental
phosphorus ..................................... 0.5% w/v

STORAGE AND HANDLING

Store between 15-30°C (59-86°F).

PRECAUTIONS

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS

Distributed By
VEDCO, INC.
St. Joseph, MO 64507

NDC: 50989-496-16

STERILE SOLUTION

NET CONTENTS: 500 mL

18-811-50

Iss. 5-06

Lot No.

Exp. Date

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALCICURE 
calcicure injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 50989-496
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Calcium Borogluconate (UNII: 6915G2PQI0) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	26 g  in 100 mL
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	15 g  in 100 mL
Magnesium Gluconate (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838)	Magnesium Gluconate	6 g  in 100 mL
Phosphorus (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	Phosphorus	0.5 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50989-496-18	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/11/2017

Labeler - Vedco (021634266)

Registrant - Vedco (021634266)

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruibang Laboratories		544807456	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Jost Chemical Co.		147882294	api manufacture