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Name:Nephrocaps
Manufacturer:American Health Packagin
Category:Over-the-counter (OTC) Marketed Drugs


NEPHROCAPS

NEPHROCAPS - ascorbic acid, folate sodium, niacin, thiamine, riboflavin, pyridoxine, cyanocobalamin, pantothenic acid and biotin capsule, liquid filled 
American Health Packagin

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.

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NEPHROCAPS

Active ingredient

Each Softgel Contains: Vitamin C 100mg; folate 1mg; niacin 20mg; thiamine 1.5mg; ribavirin 1.7mg; Vitamin B-6 10mg; Vitamin B-12 6mcg; pantothenic acid 5mg and biotin 150mcg.

Suggested Usage

In the wasting syndrome in chronic renal failure; uremia; impaired metabolic functions of the kidney and to maintain levels when the 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. Keep out of reach of children.

Ingredients

Soybean oil, ascorbic acid, gelatin, glycerin, niacinamide, dibasic calcium phosphate, calcium pantothenate, lecitin, pyridoxine HCl, yellow wax, thiamine mononitrate, riboflavin, folic acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, biotin, titanium dioxide and cyanocobalamin.

Storage

Store between 15-30 degrees C, not more than 50% relative humidity. Keep container tightly closed and protected form heat and moisture.

Mfg for:
Fleming Pharmaceuticals
Fenton, MO 63026
www.flemingpharma.com
Mfg by
R.P. Scherer
Clearwater, Fl 33716

Package/Label Principal Display Panel

Nephrocaps UD label

Package/Label Principal Display Panel

Nephrocaps 30ct label

Package/Label Principal Display Panel

Nephrocaps 90ct label


NEPHROCAPS 
nephrocaps capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG 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) ASCORBIC ACID 100 mg
FOLATE SODIUM (FARLETUZUMAB) FOLATE SODIUM 1 mg
NIACIN (NIACIN) NIACIN 20 mg
THIAMINE (THIAMINE) THIAMINE 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.7 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 10 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 6 ug
PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 5 ug
BIOTIN (BIOTIN) BIOTIN 150 ug
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL  
ASCORBIC ACID  
GELATIN  
GLYCERIN  
NIACINAMIDE  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
CALCIUM PANTOTHENATE  
PYRIDOXINE HYDROCHLORIDE  
WAX, YELLOW  
THIAMINE MONONITRATE  
RIBOFLAVIN  
FOLIC ACID  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
BIOTIN  
TITANIUM DIOXIDE  
CYANOCOBALAMIN  
Product Characteristics
Color BLACK Score no score
Shape OVAL Size 6mm
Flavor Imprint Code A
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-065-01 10 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK (68084-065-11)
1 NDC:68084-065-11 10 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACK This package is contained within the CARTON (68084-065-01)
2 NDC:68084-065-30 30 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLE None
3 NDC:68084-065-90 90 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/14/2010

Labeler - American Health Packagin (007914906)
Establishment
Name Address ID/FEI Operations
American Health Pacakaging 007914906 REPACK
Establishment
Name Address ID/FEI Operations
Fleming & Co. 150712805 MANUFACTURE

Revised: 01/2010 American Health Packagin



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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