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Name:Reno Caps
Manufacturer:Nnodum Pharmaceuticals
Category:Prescription Marketed Drugs


Reno Caps

RENO CAPS  - ascorbic acid, thiamine, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, biotin and pantothenic acid capsule 
Nnodum Pharmaceuticals

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.

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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

3514d16a-figure-01

RENO CAPS 
reno caps capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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 Multilevel Packaging
1 NDC:63044-622-01 100 CAPSULE ( CAPSULE) in 1 BOTTLE None

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



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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