RENAL CAPS DIALYSIS/STRESS VITAMIN SUPPLEMENT- ascorbic acid, thiamine mononitrate,riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, capsule, liquid filled

Renal Caps by

Drug Labeling and Warnings

Renal Caps by is a Prescription medication manufactured, distributed, or labeled by Cypress Pharmaceutical, Inc., Accucaps Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

Renal Caps are opaque black oval softgels imprinted "C 162".  These softgels provide water-soluble vitamins.  Renal Caps contain the following inactive ingredients: Blue 1 Lake, gelatin, glycerin, lecithin, Red 40 Lake, soybean oil, starch, titanium dioxide, Yellow # 6 Lake, yellow beeswax.

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).........................................1mg

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

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

Pantothenic Acid (as calcium pantothenate)..5 mg

Indications and Usage

Renal Caps is indicated in the wasting syndrome of chronic renal failure; uremia and impaired metabolic functions of the kidney.  Renal Caps ia also highly effective as a stress vitamin.

Precautions

Folic acid may mask the symptoms of pernicious anemia in that hematologic remission may occur while neurological manifestations progress.

Dosage and Administration

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

Storage

Store at controlled room temperature 15-30o C (59-86oF).  Keep container tightly closed and protected from heat and moisture.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Manufactured for Cypress Pharmaceutical, Inc.

Madison, MS  39110

L404 Rev 6/02

PRINCIPAL DISPLAY PANEL - 100 Softgel Bottle Label

Product Code 60258-162-01

Renal Caps

Dietary Supplement

CYPRESS
PHARMACEUTICAL, INC.

100 Softgels

INGREDIENTS AND APPEARANCE

RENAL CAPS  DIALYSIS/STRESS VITAMIN SUPPLEMENT
ascorbic acid, thiamine mononitrate,riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, capsule, liquid filled

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 60258-162
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (Thiamine ION - UNII:4ABT0J945J)	THIAMINE	1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.7 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	6000 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	150000 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB)	PANTOTHENIC ACID	5 mg

Product Characteristics
Color	black (C;162)	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	C;162
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60258-162-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/31/2002

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Registrant - Cypress Pharmaceutical, Inc. (790248942)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited		248441727	manufacture(60258-162)