CAL-PHOS 2 WITH POTASSIUM- cal-phos 2 with potassium injection injection, solution

Cal-Phos 2 With Potassium by

Drug Labeling and Warnings

Cal-Phos 2 With Potassium by is a Animal medication manufactured, distributed, or labeled by Clipper, Nova-Tech, Inc., Zhejiang Ruibang Laboratories, K+S KALI GmbH, Jost Chemical Co., Purac Biochem B.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMPOSITION:

Each 500 mL of sterile aqueous
solution contains:
Calcium ......................... 10.8 g
  (as calcium borogluconate, equivalent
  to calcium gluconate 23.2%)
Potassium ....................... 8.0 g
  (as potassium chloride)
Phosphorus ..................... 2.5 g
  (as sodium hypophosphite.H2O)
Magnesium ..................... 1.6 g
  (as magnesium borogluconate)
Dextrose.H2O ................ 75.0 g

Milliequivalents per liter

Cations
  Calcium .................. 1,080 mEq/L
  Potassium ................. 410 mEq/L
  Magnesium ............... 261 mEq/L
  Sodium .................... 161 mEq/L

Anions
  Borogluconate ......... 1,341 mEq/L
  Chloride .................... 410 mEq/L
  Hypophosphite ........... 161 mEq/L

INDICATIONS:

For use as an aid in the treatment
of hypocalcemia (parturient paresis, milk fever),
hypomagnesemia (grass tetany), and other
conditions associated with calcium, magnesium,
phosphorus and potassium deficiencies in cattle.

CONTRAINDICATIONS:

Do not administer this
product to animals showing signs of cardiac
distress.

PRECAUTIONS:

Administration should be made
slowly and with care to avoid adverse effects such
as heart block or shock. Perivascular or subcu-
taneous deposition of hypertonic solutions may
result in severe inflammation at the injection site.

CAUTION:

This product contains no preservatives.
Use entire contents when first opened. Discard any
unused solution.

DOSAGE AND ADMINISTRATION:

Warm solution to body temper-
ature. The usual intravenous dose
in cattle is 500 mL per 800 to
1,000 pounds of body weight.

STORAGE AND HANDLING

Store between 15 degrees C and 30 degrees C (59 degrees F and 86 degrees F).

VETERINARY INDICATIONS

FOR ANIMAL USE ONLY

CAUTION:

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

WARNINGS AND PRECAUTIONS

KEEP OUT OF REACH OF CHILDREN

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS

18-805
RMS 92-543     Rev. 03-14

Lot No.            Exp. Date

For Treatment of Milk Fever in Cattle

Net Contents: 500 mL

Manufactured for:
Clipper Distributing Company, LLC
St. Joseph, MO 64507

Trademarks are property of
Clipper Distributing Company, LLC

Manufactured by
Nova-Tech Inc.
Grand Island, NE 68801

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAL-PHOS 2 WITH POTASSIUM 
cal-phos 2 with potassium injection injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 57319-544
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextrose monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	Dextrose monohydrate	75.0 g  in 500 mL
Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CATION	8.0 g  in 500 mL
Calcium Gluconate Monohydrate (UNII: CZN0MI5R31) (CALCIUM CATION - UNII:2M83C4R6ZB)	Calcium Gluconate Monohydrate	10.8 g  in 500 mL
Phosphorus (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	Phosphorus	2.5 g  in 500 mL
Magnesium Gluconate (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838)	Magnesium Gluconate	1.6 g  in 500 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57319-544-07	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2015

Labeler - Clipper (150711039)

Registrant - Clipper (150711039)

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

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

Establishment
Name	Address	ID/FEI	Business Operations
K+S KALI GmbH		507531213	api manufacture

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

Establishment
Name	Address	ID/FEI	Business Operations
Purac Biochem B.V.		405232687	api manufacture