Label: AMCALCILYTE FORTE- amcalcilyte solution

  • NDC Code(s): 57319-525-08
  • Packager: Clipper Distributing Company, LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 4, 2024

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  • INDICATIONS & USAGE

    Oral Solution

    ELECTROLYTES - DEXTROSE - AMINO ACIDS

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

    INDICATIONS

    For use as a supplemental nutritive source of electolytes, dextrose and amino acids in cattle.

  • DOSAGE AND ADMINISTRATION

    Administer orally as a drench. The usual recommended dose in adult cattle is 500 to 1000 mL, depending on size and condition.

    SHAKE WELL BEFORE USING

  • STORAGE AND HANDLING

    STORE AT CONTROLLED ROOM TEMPERATURE
    BETWEEN 15º and 30ºC (59º-86ºF)

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • COMPOSITION

    Each 1000 mL of aqueous solution contains:

    Dextrose • H2O ....................................... 275.0 g
    Calcium Hypophosphite ............................ 36.5 g
    Potassium Chloride .................................. 15.0 g
    Sodium Chloride ........................................ 2.0 g
    Potassium Phosphate, monobasic ............... 0.5 g

    Comprised of: L-Glutamic Acid, L-Arginine Hydrochloride, L-Proline, L-Lysine Hydrochloride, L-Leuicne, L-Phenylalanine, L-Valine, L-Threonine, L-Isoleucine, L-Histidine Hydrochloride, L-Metionine, L-Tyrosine, with Methylparaben (preservative) 0.09%, Propylparaben (preservative)0.01%

  • PRINCIPAL DISPLAY PANEL

    Amcalcilyte ForteAmcalcilyte ForteAmcalcilyte ForteAmcalcilyte Forte

  • INGREDIENTS AND APPEARANCE
    AMCALCILYTE   FORTE
    amcalcilyte solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57319-525
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM HYPOPHOSPHITE (UNII: CUI83R2732) (PHOSPHATE ION - UNII:NK08V8K8HR) PHOSPHORUS36.5 g  in 1000 mL
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE275 g  in 1000 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE275 g  in 1000 mL
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, MONOBASIC2 g  in 1000 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.5 g  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-525-081000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/15/2019
    Labeler - Clipper Distributing Company, LLC (150711039)
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