Myhephrondialysis and stress supplement capsule

Supplemental factsserving 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 15-30C (59-86F). 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.

Ingredients and appearance - Product information

Myhephrondialysis and stress supplement capsule- Ascorbic acid, folate, niacin, thiamine, riboflavin, pyridoxine, cyanocobalamin, pantothenic acid, biotin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 58607-185
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ascorbic acid ( UNII: PQ6CK8PD0R)( Ascorbic acid - UNII: PQ6CK8PD0R ) 100 mgin 1
Folic acid ( UNII: 935E97BOY8)( Folic acid - UNII: 935E97BOY8 ) 1 mgin 1
Niacin ( UNII: 2679MF687A)( Niacin - UNII: 2679MF687A ) 20 mgin 1
Thiamine ( UNII: X66NSO3N35)( Thiamine ion - UNII: 4ABT0J945J ) 1.5 mgin 1
Riboflavin ( UNII: TLM2976OFR)( Riboflavin - UNII: TLM2976OFR ) 1.7 mgin 1
Pyridoxine ( UNII: KV2JZ1BI6Z)( Pyridoxine - UNII: KV2JZ1BI6Z ) 10 mgin 1
Cyanocobalamin ( UNII: P6YC3EG204)( Cyanocobalamin - UNII: P6YC3EG204 ) 6 ugin 1
Pantothenic acid ( UNII: 19F5HK2737)( Pantothenic acid - UNII: 19F5HK2737 ) 5 mgin 1
Biotin ( UNII: 6SO6U10H04)( Biotin - UNII: 6SO6U10H04 ) 150 ugin 1

Inactive Ingredients

Ingredient Name Code
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

Color black Shape capsule
Size 18 mm Score 1
Imprint Code MYNEPHRON;ME185

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Martin Ekwealor Pharmaceu( 010759905)

Establishment

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

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