Label: NEPHROCAPS- ascorbic acid, thiamine, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, biotin and pantothenic acid capsule, liquid filled

  • NDC Code(s): 0256-0185-04, 0256-0185-05, 0256-0185-08
  • Packager: Fleming & Company, Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 09/10

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  • DESCRIPTION

    Nephrocaps® are opaque black oval softgels imprinted “n”. These softgels provide water-soluble vitamins.

    Each softgel contains:

    Vitamin C (ascorbic acid)…………………………..100 mg

    Thiamine (as thiamine mononitrate).........................1.5 mg

    Riboflavin.................................................................1.7 mg

    Niacin (as niacinamide).............................................20 mg

    Vitamin B6 (as pyridoxine HCl)...............................10 mg

    Folate (folic acid)........................................................1 mg

    Vitamin B12 (as cyanocobalamin)............................6 mcg

    Biotin......................................................................150 mcg

    Pantothenic Acid (as calcium pantothenate)………..5 mg

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  • 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 is excessive. Also, highly effective as a stress vitamin. 

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  • PRECAUTIONS

    Folic acid may mask the symptoms of pernicious anemia in that hematologic remission may occur while neurologic manifestations remain progressive. 

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  • DOSAGE AND ADMINISTRATION

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

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  • Storage

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep container tightly closed and protected from heat and moisture.

    To report a serious adverse event or obtain product information contact 1-800-343-9497.

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  • Keep out of reach of children.
  • HOW SUPPLIED

    Nephrocaps® (Dialysis/Stress Vitamin Supplement) are supplied in bottles with 30 (NDC 0256-0185-04) or 90 (NDC 0256-0185-05) softgels.

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC 0256-0185-05

    Rx Only

    NEPHROCAPS®
    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 B-6 10 mg, Vitamin B-12 6 mcg, pantothenic acid 5 mg and biotin 150 mcg.

    90 SOFTGELS

    Fleming Pharmaceuticals
    St. Louis, MO 63026

    Mfg. for Fleming Pharmaceuticals.

    Lot No.

    Exp. Date

    L225 Rev.0909


    Principal Display Panel - Bottle Label, 90 Softgels

    Bottle Label - 90 Softgels

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  • INGREDIENTS AND APPEARANCE
    NEPHROCAPS 
    ascorbic acid, folic acid, niacin, thiamine, riboflavin, pyridoxine, cyanocobalamin, pantothenic acid, biotin capsule, liquid filled
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0256-0185
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE - UNII:X66NSO3N35) THIAMINE 1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.7 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 20 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 6 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 150 ug
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 5 mg
    Product Characteristics
    Color BLACK (White imprint) Score no score
    Shape CAPSULE (Oval) Size 13mm
    Flavor Imprint Code n
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0256-0185-05 90 in 1 BOTTLE
    2 NDC:0256-0185-04 30 in 1 BOTTLE
    3 NDC:0256-0185-08 12 in 1 TRAY
    3 5 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 02/01/1993
    Labeler - Fleming & Company, Pharmaceuticals (006491351)
    Establishment
    Name Address ID/FEI Business Operations
    CATALENT PHARMA SOLUTIONS, INC. 051762268 MANUFACTURE
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