CYANOPLEX: Product Information

CYANOPLEX — cyanocobalamin, niacinamide, dexpanthenol, pyridoxine hydrochloride, riboflavin 5′-phosphate sodium and thiamine hydrochloride injection
Sparhawk Laboratories, Inc.

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.

INJECTION

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

INDICATIONS

For use as a supplemental source of B-complex vitamins in cattle, swine and sheep.

PRECAUTIONS

Hypersensitivity reactions to the parenteral administration of products containing thiamine have been reported. Administer with caution and keep treated animals under close observation.

DOSAGE AND ADMINISTRATION

Subcutaneous or Intramuscular injection is recommended. May be administered intravenously at the discretion of a veterinarian. The following are suggested dosages depending on the condition of the animal and the desired response.

Adult Cattle-1 to 2 mL per 500 pounds of body weight

Calves, Swine and Sheep-1 to 2 mL. May be repeated once or twice weekly.

COMPOSITION

Each mL of sterile aqueous solution contains:

Thiamine Hydrochloride (B₁ ) ………… 1.25 mg
Niacinamide ……………………………… 12.5 mg
Pyridoxine Hydrochloride (B₆ ) ………… 5.0 mg
d-Panthenol ……………………………….. 5.0 mg
Riboflavin (B₂ ) …………………………….. 2.0 mg
(as Riboflavin 5′ phosphate sodium)
Cyanocobalamin (B₁₂ ) ………………. 1000 mcg

with Benzyl Alcohol 1.5% v/v as preservative, Ammonium Sulfate 0.1%.

Store at controlled room temperature between 15° and 30°C (59°-86°)

Protect from sunlight.

TAKE TIME OBSERVE LABEL DIRECTIONS

CYANOPLEX cyanocobalamin, niacinamide, dexpanthenol, pyridoxine hydrochloride, riboflavin 5 phosphate sodium, thiamine hydrochloride injection

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58005-610 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 1000 ug in 1 mL NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 12.5 mg in 1 mL DEXPANTHENOL (DEXPANTHENOL) DEXPANTHENOL 5.0 mg in 1 mL PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 5.0 mg in 1 mL RIBOFLAVIN 5′-PHOSPHATE SODIUM (FLAVIN MONONUCLEOTIDE) FLAVIN MONONUCLEOTIDE 2.0 mg in 1 mL THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 1.25 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58005-610-04 100 mL in 1 VIAL None 2 NDC:58005-610-05 250 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/1997

Labeler — Sparhawk Laboratories, Inc. (147979082)

Revised: 05/2017 Sparhawk Laboratories, Inc.