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

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated September 1, 2015

If you are a consumer or patient please visit this version.

  • 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

    product label

  • INGREDIENTS AND APPEARANCE
    CAL-PHOS 2 WITH POTASSIUM 
    cal-phos 2 with potassium injection injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57319-544
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextrose monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose monohydrate75.0 g  in 500 mL
    Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION8.0 g  in 500 mL
    Calcium Gluconate Monohydrate (UNII: CZN0MI5R31) (CALCIUM CATION - UNII:2M83C4R6ZB) Calcium Gluconate Monohydrate10.8 g  in 500 mL
    Phosphorus (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) Phosphorus2.5 g  in 500 mL
    Magnesium Gluconate (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838) Magnesium Gluconate1.6 g  in 500 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-544-07500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2015
    Labeler - Clipper (150711039)
    Registrant - Clipper (150711039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ruibang Laboratories544807456api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    K+S KALI GmbH507531213api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Jost Chemical Co.147882294api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Purac Biochem B.V.405232687api manufacture