Tuesday, September 13, 2016

Nephrocaps



ascorbic acid, thiamine, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, biotin and pantothenic acid

Dosage Form: capsule, liquid filled
Nephrocaps® - DIALYSIS/STRESS Vitamin Supplement

Nephrocaps Description


Nephrocaps® are opaque black oval softgels imprinted “n”. These softgels provide water-soluble vitamins.


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


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


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


Pantothenic Acid (as calcium pantothenate)………..5 mg



Indications and Usage for Nephrocaps


 In the wasting syndrome in chronic renal failure; uremia; impaired metabolic functions of the kidney and to maintain levels when dietary intake of vitamins is inadequate or excretion or loss is excessive. Also, highly effective as a stress vitamin. 



Precautions


Folic acid may mask the symptoms of pernicious anemia in that hematologic remission may occur while neurologic manifestations remain progressive. 



Nephrocaps Dosage and Administration


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



Storage


Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep container tightly closed and protected from heat and moisture.


To report a serious adverse event or obtain product information contact 1-800-343-9497.



Keep out of reach of children.



How is Nephrocaps Supplied


Nephrocaps® (Dialysis/Stress Vitamin Supplement) are supplied in bottles with 30 (NDC 0256-0185-04) or 90 (NDC 0256-0185-05) softgels.



PACKAGE/LABEL PRINCIPAL DISPLAY PANEL


NDC 0256-0185-05


Rx Only


Nephrocaps®

DIALYSIS/STRESS

Vitamin Supplement


Each Softgel Contains: Vitamin C 100 mg, folate 1 mg, niacin 20 mg, thiamine 1.5 mg, riboflavin 1.7 mg, Vitamin B-6 10 mg, Vitamin B-12 6 mcg, pantothenic acid 5 mg and biotin 150 mcg.


90 SOFTGELS


Fleming Pharmaceuticals

St. Louis, MO 63026


Mfg. for Fleming Pharmaceuticals.


Lot No.


Exp. Date


L225 Rev.0909




Bottle Label - 90 Softgels










Nephrocaps 
ascorbic acid, folic acid, niacin, thiamine, riboflavin, pyridoxine, cyanocobalamin, pantothenic acid, biotin  capsule, liquid filled










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0256-0185
Route of AdministrationORALDEA Schedule    
































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (ASCORBIC ACID)ASCORBIC ACID100 mg
THIAMINE (THIAMINE)THIAMINE1.5 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN1.7 mg
NIACIN (NIACIN)NIACIN20 mg
PYRIDOXINE (PYRIDOXINE)PYRIDOXINE10 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN6 ug
BIOTIN (BIOTIN)BIOTIN150 ug
PANTOTHENIC ACID (PANTOTHENIC ACID)PANTOTHENIC ACID5 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBLACK (White imprint)Scoreno score
ShapeCAPSULE (Oval)Size13mm
FlavorImprint Coden
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
10256-0185-0590 CAPSULE In 1 BOTTLENone
20256-0185-0430 CAPSULE In 1 BOTTLENone
30256-0185-0812 BOTTLE In 1 TRAYcontains a BOTTLE
35 CAPSULE In 1 BOTTLEThis package is contained within the TRAY (0256-0185-08)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/01/1993


Labeler - Fleming & Company, Pharmaceuticals (006491351)









Establishment
NameAddressID/FEIOperations
CATALENT PHARMA SOLUTIONS, INC.051762268MANUFACTURE
Revised: 09/2010Fleming & Company, Pharmaceuticals




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