MYHEPHRON DIALYSIS AND STRESS SUPPLEMENT- ascorbic acid, folate, niacin, thiamine, riboflavin, pyridoxine, cyanocobalamin, pantothenic acid, biotin capsule 
Martin Ekwealor Pharmaceu

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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Mynephron - 185

Supplemental Facts
Serving Size: 1 capsule daily

Each capsule contains:

                                                            Amount Per Serving

Vitamin C (ascorbic acid)                           100 mg

Folate (as Vitamin B9)                                  1 mg

Niacin (as Vitamin B3)                                 20 mg

Thiamine (as Vitamin B1)                            1.5 mg

Riboflavin (as Vitamin B2)                           1.7 mg

Pyridoxine HCL (as Vitamin B6)                    10 mg

Cyanocobalamin (as Vitamin B12)                 6 mcg

Pantothenic Acid (as Vitamin B5)                   5 mg

Biotin (as Vitamin B7)                              150 mcg

DESCRIPTION:

Mynephron capsules are opaque black capsules imprinted with "ME 185". Mynephron capsules are formulated with water-soluble vitamins intended to replace specific vitamin loss during dialysis.

INDICATIONS AND USAGE:

Mynephron capsule is indicated in the wasting syndrome of chronic renal failure, uremia and impaired metabolic functions of the kidney, and to maintain levels when the dietary intake of vitamins is inadequate or excretion (loss) is excessive. Mynephron is also highly effective as a stress vitamin.

OTHER INGREDIENTS:

FD&C Blue 1 Lake, FD&C Red 40 Lake, Gelatin, Sodium Lauryl Sulfate, Maltodextrin.

PRECAUTIONS:

Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestions remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

DOSAGE AND ADMINISTRATION:

One capsule daily, or as directed by a physician. If on dialysis, take after treatment.

STORAGE:

Store at room temperature 15-30°C (59-86°F). Keep container tightly closed and protected from heat and moisture.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Mynephron product label

M.E.

PHARMACEUTICALS, INC.

​​58607-185-10

Mynephron™

CAPSULES

Dialysis and Stress Vitamin Supplement

100 Capsules

Rx Only

M.E. Pharmaeuticals, Inc.

Richmond, IN 47374 USA

ME Pharm Mynephron2

ME Pharm Mynephron3

MYHEPHRON  DIALYSIS AND STRESS SUPPLEMENT
ascorbic acid, folate, niacin, thiamine, riboflavin, pyridoxine, cyanocobalamin, pantothenic acid, biotin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58607-185
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN20 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 ug
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN150 ug
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
ColorblackScoreno score
ShapecapsuleSize18mm
FlavorImprint Code MYNEPHRON;ME185
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58607-185-10100 in 1 BOX; Type 0: Not a Combination Product08/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2016
Labeler - Martin Ekwealor Pharmaceu (010759905)
Registrant - Martin Ekwealor Pharmaceu (010759905)
Establishment
NameAddressID/FEIBusiness Operations
Martin Ekwealor Pharmaceu010759905manufacture(58607-185)

Revised: 8/2016
Document Id: f7c4547b-8ed1-47d0-a53b-664596953446
Set id: 5fc73ffc-5d0e-4d94-b4e5-8043d58fb59b
Version: 1
Effective Time: 20160802
 
Martin Ekwealor Pharmaceu