Label: GLUC-AMINO-FORTE 57319-535- glucaminolyte solution

  • NDC Code(s): 57319-535-08
  • Packager: Clipper Distributing Company, LLC
  • 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 25, 2018

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  • INDICATIONS & USAGE

    Oral Solution

    Dextrose - Electrolytes - Amino Acids

    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.

  • STORAGE AND HANDLING

    STORE AT CONTROLLED ROOM TEMPERATURE BETWEEN 15° and 30°C (59° and 86°)

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • COMPOSITION

    Each 1000 mL of aqueous solution contains:

    Dextrose • H2O ........................... 300 g
    Sodium Chloride ........................... 5.4 g
    Sodium Acetate, Anhydrous .......... 3.0 g
    Potassium Acetate ....................... 1.0 g
    Calcium Chloride • 2H2O ........ 330.0 mg
    Magnesium Chloride • 5H2O ... 260.0 mg

    Containing Amino Acids:

    L-Glutamic Acid, L-Arginine, Hydrochloride, L-Proline, L-Lysine Hydrochloride, L-Leucine, L-Phenylalanine, L-Valine, L-Threonine, L-Isoleucine, L-Histidine Hydrochloride, L-Methionine, L-Tyrosine.

    Methylparaben (preservative) 0.18% and Propylparaben (preservative) 0.02%.

  • PRINCIPAL DISPLAY PANEL

    PX Gluco-Amino-Forte

  • INGREDIENTS AND APPEARANCE
    GLUC-AMINO-FORTE  57319-535
    glucaminolyte solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57319-535
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE330 mg  in 1000 mL
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE300 g  in 1000 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE260 mg  in 1000 mL
    POTASSIUM ACETATE (UNII: M911911U02) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM ACETATE1 g  in 1000 mL
    SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37) SODIUM ACETATE ANHYDROUS3 g  in 1000 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE5.4 g  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-535-081000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2007
    Labeler - Clipper Distributing Company, LLC (150711039)