Nephrocaps

Pronunciation

Generic Name: ascorbic acid, thiamine, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, biotin and pantothenic acid
Dosage Form: capsule, liquid filled

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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.

Nephrocaps® - DIALYSIS/STRESS Vitamin Supplement

Nephrocaps Description

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

Indications and Usage for Nephrocaps

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). Keep container tightly closed and protected from heat and moisture.

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

Keep out of reach of children.

How is Nephrocaps Supplied

Nephrocaps® (Dialysis/Stress Vitamin Supplement) are supplied in bottles with 30 (NDC 0187-5268-01), 90 (NDC 0187-5268-02), or 5 (NDC 0187-5268-03) softgels.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0187-5268-02

Rx Only

Nephrocaps®
DIALYSIS/STRESS
Vitamin Supplement

Each Softgel Contains: Vitamin C 100 mg, folate 1 mg, niacin 20 mg, thiamine 1.5 mg, riboflavin 1.7 mg, Vitamin B-6 10 mg, Vitamin B-12 6 mcg, pantothenic acid 5 mg and biotin 150 mcg.

90 SOFTGELS

Valeant Pharmaceuticals North America LLC

Lot No.

Exp. Date

L786-1 Rev.0212

Bottle Label - 90 Softgels

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:0187-5268
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (ASCORBIC ACID)	ASCORBIC ACID	100 mg
THIAMINE (THIAMINE)	THIAMINE	1.5 mg
RIBOFLAVIN (RIBOFLAVIN)	RIBOFLAVIN	1.7 mg
NIACIN (NIACIN)	NIACIN	20 mg
PYRIDOXINE (PYRIDOXINE)	PYRIDOXINE	10 mg
FOLIC ACID (FOLIC ACID)	FOLIC ACID	1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)	CYANOCOBALAMIN	6 ug
BIOTIN (BIOTIN)	BIOTIN	150 ug
PANTOTHENIC ACID (PANTOTHENIC ACID)	PANTOTHENIC ACID	5 mg

Product Characteristics
Color	BLACK (White imprint)	Score	no score
Shape	CAPSULE (Oval)	Size	13mm
Flavor		Imprint Code	n
Contains

Packaging
#	Item Code	Package Description
1	NDC:0187-5268-02	90 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
2	NDC:0187-5268-01	30 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
3	NDC:0187-5268-03	12 BOTTLE (BOTTLE) in 1 TRAY
3		5 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/18/2012

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Operations
Catalent Pharma Solutions LLC		051762268	MANUFACTURE

Revised: 06/2012