Label: AMINO ACID ORAL- amino acid solution

  • NDC Code(s): 57319-528-04
  • Packager: Clipper Distributing Company, LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated June 5, 2024

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  • INDICATIONS & USAGE

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

    INDICATIONS

    For use as a nutritional supplement of vitamins, amino acids and electrolytes for cattle, swine, sheep and horses.

  • DOSAGE AND ADMINISTRATION

    For use in drinking water.  Supply fresh water daily.

    Cattle: Administer 1 oz. per 10 pounds body weight in the drinking water consumed in one day.

    Horses: Administer 10 ozs. per 100 pounds body weight in the drinking water consumed in one day.

    Sheep and Swine: Administer 1 oz. per 10 pounds body weight i the drinking water consume in one day.

  • STORAGE AND HANDLING

    PROTECT FROM LIGHT.

    STORE AT 15o-30oC (59o-86oF).

  • COMPONENTS

    image description

  • PRINCIPAL DISPLAY PANEL

    AA Solution

  • INGREDIENTS AND APPEARANCE
    AMINO ACID   ORAL
    amino acid solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57319-528
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE5000 mg  in 100 mL
    CALCIUM CHLORIDE ANHYDROUS (UNII: OFM21057LP) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION15 mg  in 100 mL
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE20  mg  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE20 mg  in 100 mL
    SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37) SODIUM ACETATE ANHYDROUS250 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    VALINE (UNII: HG18B9YRS7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-528-04500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2010
    Labeler - Clipper Distributing Company, LLC (150711039)
    Registrant - Sparhawk Laboratories, Inc. (147979082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparhawk Laboratories, Inc.147979082analysis, api manufacture, manufacture
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