MYNEPHROCAPS DIALYSIS/STRESS VITAMIN SUPPLEMENT- ascorbic acid, niacinamide, pyridoxine hydrochloride, calcium pantothenate, thiamine mononitrate, folic acid, biotin, cyanocobalamin capsule

MYNEPHROCAPS by

Drug Labeling and Warnings

MYNEPHROCAPS by is a Prescription medication manufactured, distributed, or labeled by MARTIN EKWEALOR PHARMACEUTICALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 58607-186
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	10 mg
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.7 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE MONONITRATE	1.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	150 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	6 ug

Inactive Ingredients
Ingredient Name	Strength
SOYBEAN OIL (UNII: 241ATL177A)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
YELLOW WAX (UNII: 2ZA36H0S2V)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	black (BLACK)	Score	no score
Shape	OVAL (Softgel;Capsule)	Size	7mm
Flavor		Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58607-186-03	100 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	Business Operations
MARTIN EKWEALOR PHARMACEUTICALS, INC.		624528386	manufacture(58607-186)