Reno Capsules

Pronunciation

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

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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.

Reno Caps

Dialysis/Stress

Vitamin Supplement

NDC 63044-622-01

RX only

Description

Renal Caps are black oval softgel imprinted “z622”. These softgels provide water- soluble vitamins.

Active Ingredients:

Each Reno Caps 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 B-6 (as pyridoxine Hcl)………………...10 mg

Folate (as folic Acid)…………………………….1 mg

Vitamin B-12 (as cyanocobalam)………………..6 mcg

Biotin……………………………………………..150 mcg

Pantothenic acid (as calcium Pantothenate)……...5 mg

Inactive Ingredients: Gelatin, glycerin, lecithin, soybean oil, yellow beeswax, titanium dioxide, FDC Yellow #6, water, FDC blue #1, FDC Red #40

Indications

Reno Caps Softgels is a prescription vitamins supplement indicated for renal disease patients to replace critical vitamins lost due to dialysis in patients with chronic renal disease, uremia and impaired metabolic kidney functions. Also used as a stress vitamin.

Precautions

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

Dosage and Administration

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

Storage: Store at controlled room temperature 15-30C (59-86 F). Keep container tightly closed and protect from heat and moisture.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

Manufactured for Nnodum Pharmaceuticals by
Banner pharmacaps
Olds, Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RENO CAPS
reno caps capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:63044-622
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

Inactive Ingredients
Ingredient Name	Strength
GELATIN
GLYCERIN
LECITHIN, SOYBEAN
SOYBEAN OIL
TITANIUM DIOXIDE
D&C YELLOW NO. 6
WATER
D&C BLUE NO. 1
D&C RED NO. 40

Product Characteristics
Color	BLACK	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	z622
Contains

Packaging
#	Item Code	Package Description
1	NDC:63044-622-01	100 CAPSULE (CAPSULE) in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		11/30/2008

Labeler - Nnodum Pharmaceuticals (960457273)

Establishment
Name	Address	ID/FEI	Operations
BANNER PHARMACAPS		242721744	MANUFACTURE

Revised: 12/2009

Nnodum Pharmaceuticals

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