Wednesday, 27 May 2009

Renal Caps



acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin and calcium pantothenate

Dosage Form: capsule, liquid filled
Renal Caps

Description


Renal Caps are opaque black oval softgels imprinted "C 162".  These softgels provide water-soluble vitamins.  Renal Caps contain the following inactive ingredients: Blue 1 Lake, gelatin, glycerin, lecithin, Red 40 Lake, soybean oil, starch, titanium dioxide, Yellow # 6 Lake, yellow beeswax.


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


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


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


Pantothenic Acid (as calcium pantothenate)..5 mg





Indications and Usage


Renal Caps is indicated in the wasting syndrome of chronic renal failure; uremia and impaired metabolic functions of the kidney.  Renal Caps ia also highly effective as a stress vitamin.



Precautions


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



Dosage and Administration


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



Storage



Store at controlled room temperature 15-30o C (59-86oF).  Keep container tightly closed and protected from heat and moisture.


KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.


Manufactured for Cypress Pharmaceutical, Inc.


Madison, MS  39110


L404 Rev 6/02



NDC 60258-162-01


Renal Caps


Dialysis/ Stress


Vitamin Supplement


Rx Only


Cypress Pharmaceutical, Inc.


100 Softgels










Renal Caps  DIALYSIS/STRESS VITAMIN SUPPLEMENT
ascorbic acid, thiamine mononitrate,riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate,   capsule, liquid filled










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)60258-162
Route of AdministrationORALDEA Schedule    
































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (ASCORBIC ACID)ASCORBIC ACID100 mg
THIAMINE MONONITRATE (THIAMINE )THIAMINE MONONITRATE1.5 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN1.7 mg
NIACINAMIDE (NIACINAMIDE)NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)PYRIDOXINE HYDROCHLORIDE10 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN6000 ug
BIOTIN (BIOTIN)BIOTIN150000 ug
CALCIUM PANTOTHENATE (CALCIUM PANTOTHENATE)CALCIUM PANTOTHENATE5 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Colorblack (C;162)Scoreno score
ShapeCAPSULESize15mm
FlavorImprint CodeC;162
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
160258-162-01100 CAPSULE In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved other10/31/2002


Labeler - Cypress Pharmaceutical, Inc. (790248942)

Registrant - Cypress Pharmaceutical, Inc. (790248942)









Establishment
NameAddressID/FEIOperations
Accucaps Industries Limited248441727manufacture
Revised: 10/2009Cypress Pharmaceutical, Inc.




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