Label: MYNEPHROCAPS DIALYSIS/STRESS VITAMIN SUPPLEMENT- ascorbic acid, niacinamide, pyridoxine hydrochloride, calcium pantothenate, thiamine mononitrate, folic acid, biotin, cyanocobalamin 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 December 13, 2013

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  • 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:

    MEPharma Mynephrocaps Label

  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58607-186
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 mg
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE MONONITRATE1.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN150 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 ug
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorblack (BLACK) Scoreno score
    ShapeOVAL (Softgel;Capsule) Size7mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58607-186-03100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/16/2013
    Labeler - MARTIN EKWEALOR PHARMACEUTICALS, INC. (624528386)
    Registrant - MARTIN EKWEALOR PHARMACEUTICALS, INC. (624528386)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARTIN EKWEALOR PHARMACEUTICALS, INC.624528386manufacture(58607-186)