RENO CAPS  - reno caps capsule 
Carilion Materials Management

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.

REN KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILD

Manufactured by :

Catalent Australia PTY LTD

Distributed by:

Nnodum Pharmaceuticals 

Cincinnati, Ohio 45240

RENO CAPS CAPSULE

Label Image
RENO CAPS  
reno caps capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68151-1928(NDC:63044-622)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN20 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN150 ug
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 ug
Inactive Ingredients
Ingredient NameStrength
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
ColorBLACKScoreno score
ShapeOVALSize7mm
FlavorImprint Code z622
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68151-1928-61 in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/30/2008
Labeler - Carilion Materials Management (079239644)
Registrant - Carilion Materials Management (079239644)
Establishment
NameAddressID/FEIBusiness Operations
Carilion Materials Management079239644REPACK(68151-1928)

Revised: 11/2013
Document Id: 429325f6-6635-4358-b4c6-640188f0ef16
Set id: c6d2fb27-a46f-418b-8bd7-aaee54e9c160
Version: 2
Effective Time: 20131111
 
Carilion Materials Management