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Nephrocaps

American Health Packaging

NEPHROCAPS® - DIALYSIS/STRESS Vitamin Supplement


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

NEPHROCAPS 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. 

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).

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 as:

NDC 68084-065-01, unit does packages of 100 (10x10)

Manufactured for:
Fleming Pharmaceuticals
Fenton, MO 63026

Repackaged by:
American Health Packaging
Columbus, Ohio 43217

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Nephrocaps

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:68084-065(NDC:0256-0185)
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:68084-065-11 10 in 1 BLISTER PACK
2 NDC:68084-065-01 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-01-14


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