Friday, October 21, 2016

Nephrocaps-QT





Dosage Form: tablet, orally disintegrating
NEPHROCAPS®QT Quick-Dissolve Tablets

DIALYSIS/RENAL Vitamin

Nephrocaps-QT Description


Quick-dissolve tablets.

























Nutrition Facts:Per Tablet

Vitamin D3 (cholecalciferol)


1750 IU

Vitamin C (ascorbic acid)


100 mg

Folate (folic acid/B9)


1 mg

Thiamin (B1)


1.5 mg

Riboflavin (B2)


1.7 mg

Niacin (B3)


20 mg

Pantothenic Acid (B5)


5 mg

Pyridoxine HCl (B6)


10 mg

Biotin (B7)


150 mcg

Vitamin B12 (cyanocobalamin)


6 mcg

Other ingredients: Mannitol, Crospovidone, Stearic Acid, Flavor, Magnesium Stearate, Sucralose, Polyvinyl Acetate.



SUGGESTED USAGE


Under the supervision of a physician for dietary management of patients with chronic renal failure; uremia; impaired metabolic functions of the kidney, and to maintain nutrient levels when dietary intake of vitamins is inadequate or excretion or loss is excessive.



Precautions


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



Nephrocaps-QT Dosage and Administration


One tablet 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.


PATENT PENDING



Keep out of reach of children.



How is Nephrocaps-QT Supplied


Bottles of 90 (NDC 0256-0233-02)


Bottles of 30 (NDC 0256-0233-01)


Bottles of 5 (NDC 0256-0233-03), 12 bottles in a tray



PACKAGE/LABEL PRINCIPAL DISPLAY PANEL


NDC 0256-0233-02


Rx Only


NEPHROCAPS® QT


QUICK-DISSOLVE TABLETS


 


DIALYSIS/RENAL Vitamin


  • Includes 1750 IU daily Vitamin D3

  • Easy to take without water

  • Pleasant fruit-punch flavor

90 QUICK-DISSOLVE TABLETS


 


Manufactured by Fleming Pharmaceuticals.


Lot No.


Exp. Date


L742 Rev.0111




Bottle Label










Nephrocaps-QT 
cholecalciferol, ascorbic acid, folic acid, thiamin, riboflavin, niacin, pantothenic acid, pyridoxine hcl, biotin, cyanocobalamin  tablet, orally disintegrating










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0256-0233
Route of AdministrationORALDEA Schedule    



































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLECALCIFEROL (CHOLECALCIFEROL)CHOLECALCIFEROL1750 [iU]
ASCORBIC ACID (ASCORBIC ACID)ASCORBIC ACID100 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID1 mg
THIAMINE HYDROCHLORIDE (THIAMINE)THIAMINE HYDROCHLORIDE1.5 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN1.7 mg
NIACIN (NIACIN)NIACIN20 mg
PANTOTHENIC ACID (PANTOTHENIC ACID)PANTOTHENIC ACID5 mg
PYRIDOXINE (PYRIDOXINE)PYRIDOXINE10 mg
BIOTIN (BIOTIN)BIOTIN150 ug
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN6 ug














Inactive Ingredients
Ingredient NameStrength
MANNITOL 
CROSPOVIDONE 
STEARIC ACID 
MAGNESIUM STEARATE 
SUCRALOSE 


















Product Characteristics
ColorYELLOW (Pale to tan)Scoreno score
ShapeROUND (Circle)Size16mm
FlavorFRUIT PUNCHImprint Coden
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
10256-0233-0290 TABLET In 1 BOTTLENone
20256-0233-0130 TABLET In 1 BOTTLENone
30256-0233-0312 BOTTLE In 1 TRAYcontains a BOTTLE
35 TABLET In 1 BOTTLEThis package is contained within the TRAY (0256-0233-03)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other03/01/2011


Labeler - Fleming & Company, Pharmaceuticals (006491351)









Establishment
NameAddressID/FEIOperations
Fleming & Company, Pharmaceuticals006491351MANUFACTURE
Revised: 02/2011Fleming & Company, Pharmaceuticals




More Nephrocaps-QT resources


  • Nephrocaps-QT Use in Pregnancy & Breastfeeding
  • Nephrocaps-QT Drug Interactions
  • Nephrocaps-QT Support Group
  • 4 Reviews for Nephrocaps-QT - Add your own review/rating


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