Label: AMCALCILYTE FORTE- amcalcilyte solution

  • NDC Code(s): 46066-242-07
  • Packager: Aspen Veterinary Resources, Ltd.
  • 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 June 26, 2017

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

View All Sections
  • INDICATIONS & USAGE

    Oral Solution

    Calcium and Electrolytes Fortified with Dextrose and Crystalline 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.

  • STORAGE AND HANDLING

    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

    AS Amcalcilyte Forte

  • INGREDIENTS AND APPEARANCE
    AMCALCILYTE   FORTE
    amcalcilyte solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-242
    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 CHLORIDE2.0 g  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-242-071000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/12/2014
    Labeler - Aspen Veterinary Resources, Ltd. (627265361)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

Related Resources

Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!