FDA.reportPublic FDA data

DEX-AMINO-LYTE

Manufacturer
IBA, Inc.
Effective date
2018-03-07
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:01:06

Label at a glance#

ProductDEX-AMINO-LYTE
Active ingredientCALCIUM HYPOPHOSPHITE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, SODIUM CHLORIDE
Label structure5 sections

Dosage and administration

Administer orally as a drench or by use of a stomach tube. The usual recommended dose in cattle is 500 to 1000 mL, depending on size and condition. TAKE TIME OBSERVE LABEL DIRECTIONS

Storage and handling

STORE AT CONTROLLED ROOM TEMPERATURE BETEWEEN 15° and 30°C (59°-86°F)

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

SOLUTION

DEXTROSE-AMINO ACIDS-ELECTROLYTES

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

INDICATIONS

For use as a supplemental nutritive source of dextrose, amino acids and electrolytes in cattle.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Administer orally as a drench or by use of a stomach tube. The usual recommended dose in cattle is 500 to 1000 mL, depending on size and condition.

TAKE TIME OBSERVE LABEL DIRECTIONS

STORAGE AND HANDLING SECTION

STORE AT CONTROLLED ROOM TEMPERATURE BETEWEEN 15° and 30°C (59°-86°F)

COMPOSITION

COMPONENTS

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%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IBA Amcal ForteIBA Amcal Forte

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29983-2702DEX-AMINO-LYTE (AMCALCILYTE) SOLUTION [IBA, INC.]1Unmatched20180308_0b2b0991-152d-48e0-864a-2c10312c941d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29983-270229983-2702-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM HYPOPHOSPHITECUI83R2732ACTIR
DEXTROSE MONOHYDRATELX22YL083GACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.