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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated August 2, 2016

If you are a consumer or patient please visit this version.

View All Sections
  • 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 15-30°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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!