Label: AMCALCILYTE FORTE- amcalcilyte solution

  • NDC Code(s): 13985-170-52
  • Packager: MWI Veterinary Supply, Inc.
  • Category: OTC 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 April 18, 2018

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  • INDICATIONS & USAGE

    Oral Drench

    Supplemental Nutritive Source

    For Animal Use Only

    Keep out of reach of children

    INDICATIONS

    For use as a supplemental nutritive source of electrolytes, 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

    Store at controlled room temperature between 15° and 30°C (59°-86°F)

    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

    V1 Amcalcilyte Forte

  • INGREDIENTS AND APPEARANCE
    AMCALCILYTE   FORTE
    amcalcilyte solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13985-170
    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 CHLORIDE15 g  in 1000 mL
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, MONOBASIC0.5 g  in 1000 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE2 g  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-170-521000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/02/2011
    Labeler - MWI Veterinary Supply, Inc. (019926120)