Nephrocaps-QT

Generic Name: cholecalciferol, ascorbic acid, folic acid, thiamine hydrochloride, riboflavin, niacin, pantothenic acid, pyridoxine, biotin and cyanocobalamin
Dosage Form: tablet, orally disintegrating

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.

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 Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0256-0233
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 1750 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE HYDROCHLORIDE 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.7 mg
NIACIN (NIACIN) NIACIN 20 mg
PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 5 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 10 mg
BIOTIN (BIOTIN) BIOTIN 150 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 6 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL  
CROSPOVIDONE  
STEARIC ACID  
MAGNESIUM STEARATE  
SUCRALOSE  
Product Characteristics
Color YELLOW (Pale to tan) Score no score
Shape ROUND (Circle) Size 16mm
Flavor FRUIT PUNCH Imprint Code n
Contains         
Packaging
# Item Code Package Description
1 NDC:0256-0233-02 90 TABLET, ORALLY DISINTEGRATING (TABLET) in 1 BOTTLE
2 NDC:0256-0233-01 30 TABLET, ORALLY DISINTEGRATING (TABLET) in 1 BOTTLE
3 NDC:0256-0233-03 12 BOTTLE (BOTTLE) in 1 TRAY
3 5 TABLET, ORALLY DISINTEGRATING (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/01/2011 10/30/2013
Labeler - Fleming & Company, Pharmaceuticals (006491351)
Establishment
Name Address ID/FEI Operations
Fleming & Company, Pharmaceuticals 006491351 MANUFACTURE
Revised: 06/2012
 
Fleming & Company, Pharmaceuticals



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