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Mynephrocaps Dialysis Stress Vitamin Supplement

Pronunciation

Generic Name: ascorbic acid, niacinamide, pyridoxine hydrochloride, calcium pantothenate, riboflavin, thiamine mononitrate, folic acid, biotin and cyanocobalamin
Dosage Form: capsule

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.

Supplemental Facts

Serving Size 1 Softgel                                                                   Serving Per Container 100

One Softgel Contains:                                                                    Amount Per Serving

Vitamin C (as ascorbic acid)                                                                                 100 mg
Niacin (as niacinamide)                                                                                          20 mg
Vitamin B ( as pyridoxine HCL)                                                                               10 mg
Pantotnenic Acid (as calcium pantothenate)                                                              5 mg
Riboflavin                                                                                                            1.7 mg
Vitamin B1 (as thiamine mononitrate)                                                                     1.5 mg
Folate (as folic acid)                                                                                                1 mg
Biotin                                                                                                                150 mcg
Vitamin B12 ( as cyanocobalamin)                                                                          6 mcg

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 in 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- 80° F). Keep container tightly closed and protected from heat and moisture.

Keep out of reach of children.

Keep out of reach of children.

Ingredients:

Soybean oil, ascorbic acid, gelatin, glycerin, niacinamide, diabasic calcium phosphate, calcium pantothenate, lecithin, pyridoxineHCL, yellow wax, thiamine monitrate, riboflavin, folic acid, FD and c blue #1, FD and C red #40, FD and C yellow #6, biotin, titanium dioxide and cyanocobalamin.

To report any adverse event or obtain product information

To report any adverse event or obtain product information contact 1-866-578-9637

Product Label

58607-186-03

MYNEPHOCAPS

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 B6 10 mg, Vitamin B12 6 mcg, Pantothenic acid 5 mg, and Biotin 150 mcg

Rx Onlt

100 Softgels

M.E. Pharmaceuticals, Inc.Richmond, IN 47374

Lot No:

Exp Date:

MYNEPHROCAPS  DIALYSIS/STRESS VITAMIN SUPPLEMENT
ascorbic acid, niacinamide, pyridoxine hydrochloride, calcium pantothenate, thiamine mononitrate, folic acid, biotin, cyanocobalamin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58607-186
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 10 mg
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.7 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE MONONITRATE 1.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
BIOTIN (BIOTIN) BIOTIN 150 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 6 ug
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL  
GELATIN  
GLYCERIN  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
LECITHIN, SOYBEAN  
YELLOW WAX  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
TITANIUM DIOXIDE  
Product Characteristics
Color black (BLACK) Score no score
Shape OVAL (Softgel;Capsule) Size 7mm
Flavor Imprint Code none
Contains         
Packaging
# Item Code Package Description
1 NDC:58607-186-03 100 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/16/2013
Labeler - MARTIN EKWEALOR PHARMACEUTICALS, INC. (624528386)
Registrant - MARTIN EKWEALOR PHARMACEUTICALS, INC. (624528386)
Establishment
Name Address ID/FEI Operations
MARTIN EKWEALOR PHARMACEUTICALS, INC. 624528386 manufacture(58607-186)
Revised: 12/2013
 
MARTIN EKWEALOR PHARMACEUTICALS, INC.



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