Myhephron Dialysis and Stress Supplement

MYHEPHRON DIALYSIS AND STRESS SUPPLEMENT- ascorbic acid, folic acid, niacin, thiamine, riboflavin, pyridoxine, cyanocobalamin, pantothenic acid and 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.

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

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58607-185 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg NIACIN (NIACIN) NIACIN 20 mg THIAMINE (THIAMINE ION) 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 mg BIOTIN (BIOTIN) BIOTIN 150 ug

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN SODIUM LAURETH-3 SULFATE MALTODEXTRIN

Product Characteristics Color black Score no score Shape capsule Size 18mm Flavor Imprint Code MYNEPHRON;ME185 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58607-185-10 100 CAPSULE in 1 BOX None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/01/2016

Labeler — Martin Ekwealor Pharmaceu (010759905)

Registrant — Martin Ekwealor Pharmaceu (010759905)

Establishment
Name	Address	ID/FEI	Operations
Martin Ekwealor Pharmaceu		010759905	manufacture (58607-185)

Revised: 08/2016 Martin Ekwealor Pharmaceu