Nephrocaps description, usages, side effects, indications, overdosage, supplying and lots more!

Nephrocaps

Valeant Pharmaceuticals North America LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
NEPHROCAPS® - DIALYSIS/STRESS Vitamin Supplement

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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. 

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 SUPPLIED

Nephrocaps® (Dialysis/Stress Vitamin Supplement) are supplied in bottles with 30 (NDC 0187-5268-01), 90 (NDC 0187-5268-02), or 5 (NDC 0187-5268-03) softgels.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0187-5268-02

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

Valeant Pharmaceuticals North America LLC

Lot No.

Exp. Date

L786-1 Rev.0212


PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Bottle Label - 90 Softgels

Nephrocaps

Ascorbic Acid, Folic Acid, Niacin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin CAPSULE, LIQUID FILLED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0187-5268
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ASCORBIC ACID ASCORBIC ACID 100 mg
Thiamine 1.5 mg
RIBOFLAVIN RIBOFLAVIN 1.7 mg
NIACIN 20 mg
PYRIDOXINE 10 mg
FOLIC ACID FOLIC ACID 1 mg
Cyanocobalamin CYANOCOBALAMIN 6 ug
BIOTIN 150 ug
PANTOTHENIC ACID 5 mg

Product Characteristics

Color Size Imprint Code Shape
BLACK (White imprint) 13 mm n CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0187-5268-02 90 in 1 BOTTLE
2 NDC:0187-5268-01 30 in 1 BOTTLE
3 5 in 1 BOTTLE
4 NDC:0187-5268-03 12 in 1 TRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-06-18


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