Label: DEX-AMINO-LYTE- amcalcilyte solution
- NDC Code(s): 29983-2702-3
- Packager: IBA, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 7, 2018
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- INDICATIONS & USAGE
- DOSAGE AND ADMINISTRATION
- STORAGE AND HANDLING
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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-Methionine, L-Tyrosine, with Methylparaben (preservative) 0.09%, Propylparaben (preservative)0.01%
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEX-AMINO-LYTE
amcalcilyte solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:29983-2702 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM HYPOPHOSPHITE (UNII: CUI83R2732) (PHOSPHATE ION - UNII:NK08V8K8HR) PHOSPHORUS 36.5 g in 1000 mL DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 275 g in 1000 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 275 g in 1000 mL POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, MONOBASIC 2 g in 1000 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 0.5 g in 1000 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29983-2702-3 1000 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/26/2009 Labeler - IBA, Inc. (019494160)
