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Nephrocaps

Cardinal Health

NEPHROCAPS® - DIALYSIS/STRESS Vitamin Supplement


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

NEPHROCAPS DESCRIPTION

Contains: Soy

Nephrocaps® are opaque black oval softgels imprinted “n”. These softgels provide water-soluble vitamins.

Each softgel contains:

Vitamin C (ascorbic acid)…………………………..100 mg

Thiamine (as thiamine mononitrate).........................1.5 mg

Riboflavin.................................................................1.7 mg

Niacin (as niacinamide).............................................20 mg

Vitamin B6 (as pyridoxine HCl)...............................10 mg

Folate (folic acid)........................................................1 mg

Vitamin B12 (as cyanocobalamin)............................6 mcg

Biotin......................................................................150 mcg

Pantothenic Acid (as calcium pantothenate)………..5 mg

Ingredients: Soybean oil, ascorbic acid, gelatin, glycerin, niacinamide, dibasic calcium phosphate, calcium pantothenate, lecithin, pyridoxine HCl, yellow wax, thiamine mononitrate, ribofloavin, folic acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, biotin, titanium dioxide and cyanocobalamin.

NEPHROCAPS INDICATIONS AND USAGE

 Suggested Use: In the wasting syndrome in chronic renal failure; uremia; impaired metabolic functions of the kidney and to maintain levels when dietary intake of vitamins is inadequate or excretion or loss is excessive. Also, highly effective as a stress vitamin. 

PRECAUTIONS

Folic acid may mask the symptoms of pernicious anemia in that hematologic remission may occur while neurologic manifestations remain progressive. 

NEPHROCAPS DOSAGE AND ADMINISTRATION

One softgel daily, or as directed by a physician. If on dialysis, take after treatment. 

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

To report a serious adverse event or obtain product information contact 1-800-343-9497.

Protect from heat and moisture.

Keep out of reach of children.

RX ONLY

WARNING

This package is intended for institutional use. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. This unit-dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized. To report a serious adverse event or obtain product information contact 1-800-343-9497.

HOW SUPPLIED

Nephrocaps® (Dialysis/Stress Vitamin Supplement) are supplied as:

NDC 68084-065-01, unit does packages of 100 (10x10)

Manufactured for:
Fleming Pharmaceuticals
St. Louis, MO 63026

www.flemingpharma.com

NDC#0256-0185

Repackaged & Distributed by:
American Health Packaging
Columbus, Ohio 43217

Americanhealthpackaging.com

Repackaged by Cardinal Health

Zanesville, OH 43701

L48850670813

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NEPHROCAPS

DIALYSIS/STRESS

Vitamin Supplement

10 Softgels

Nephrocaps

Nephrocaps

Ascorbic Acid, Folic Acid, Niacin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin CAPSULE, LIQUID FILLED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55154-4796(NDC:68084-065)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ASCORBIC ACID ASCORBIC ACID 100 mg
Thiamine 1.5 mg
RIBOFLAVIN RIBOFLAVIN 1.7 mg
NIACIN 20 mg
PYRIDOXINE 10 mg
FOLIC ACID FOLIC ACID 1 mg
Cyanocobalamin CYANOCOBALAMIN 6 ug
BIOTIN 150 ug
PANTOTHENIC ACID 5 mg

Product Characteristics

Color Size Imprint Code Shape
BLACK (White imprint) 13 mm n CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-4796-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-01-14


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