RENO CAPS  - ascorbic acid, thiamine, riboflavin, niacin, pyridoxine, folic acid, biotin, pantothenic acid and cyanocobalamin 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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Unknown Title

DESCRIPTION

Reno 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 by :

Catalent Australia PTY LTD

Distributed by:

Nnodum Pharmaceuticals 

Cincinnati, Ohio 45240

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

71d7f6ee-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 (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.7 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 20 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 150 ug
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 5 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 6 ug
Inactive Ingredients
Ingredient Name Strength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SOYBEAN OIL (UNII: 241ATL177A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color BLACK Score no score
Shape OVAL Size 7mm
Flavor Imprint Code z622
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63044-622-01 100 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)
Registrant - Nnodum Pharmaceuticals (960457273)
Establishment
Name Address ID/FEI Business Operations
Catalent Australia PTY LTD 753617638 ANALYSIS(63044-622) , MANUFACTURE(63044-622)
Establishment
Name Address ID/FEI Business Operations
Banner Pharmacaps 242721744 ANALYSIS(63044-622) , MANUFACTURE(63044-622)

Revised: 11/2013
Document Id: 71d7f6ee-3907-4214-8758-0f374526b6be
Set id: 78cffb5d-1752-4529-ad6f-2a5357774696
Version: 7
Effective Time: 20131111
 
Nnodum Pharmaceuticals