Label: RENO CAPS - ascorbic acid, thiamine, riboflavin, niacin, pyridoxine, folic acid, biotin, pantothenic acid and cyanocobalamin capsule

  • NDC Code(s): 63044-622-01
  • Packager: Nnodum Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 11/13

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  • DESCRIPTION

    Reno Caps are black oval softgel imprinted “z622”. These softgels provide water- soluble vitamins.

    Active Ingredients:

    Each Reno Caps 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 B-6 (as pyridoxine Hcl)………………...10 mg

    Folate (as folic Acid)…………………………….1 mg

    Vitamin B-12 (as cyanocobalam)………………..6 mcg

    Biotin……………………………………………..150 mcg

    Pantothenic acid (as calcium Pantothenate)……...5 mg

    Inactive Ingredients: Gelatin, glycerin, lecithin, soybean oil, yellow beeswax, titanium dioxide, FDC Yellow #6, water, FDC blue #1, FDC Red #40

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  • INDICATIONS

    Reno Caps Softgels is a prescription vitamins supplement indicated for renal disease patients to replace critical vitamins lost due to dialysis in patients with chronic renal disease, uremia and impaired metabolic kidney functions. Also used 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 neurological manifestations progess.

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  • DOSAGE AND ADMINISTRATION

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

    Storage: Store at controlled room temperature 15-30C (59-86 F). Keep container tightly closed and protect from heat and moisture.

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

    Manufactured by :

    Catalent Australia PTY LTD

    Distributed by:

    Nnodum Pharmaceuticals 

    Cincinnati, Ohio 45240

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    RENO CAPS  
    reno caps capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63044-622
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
    THIAMINE (THIAMINE ION) THIAMINE 1.5 mg
    RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.7 mg
    NIACIN (NIACIN) NIACIN 20 mg
    PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 10 mg
    FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
    BIOTIN (BIOTIN) BIOTIN 150 ug
    PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 5 mg
    CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 6 ug
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN  
    GLYCERIN  
    LECITHIN, SOYBEAN  
    SOYBEAN OIL  
    TITANIUM DIOXIDE  
    FD&C YELLOW NO. 6  
    WATER  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    Product Characteristics
    Color BLACK Score no score
    Shape OVAL Size 7mm
    Flavor Imprint Code z622
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63044-622-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 11/30/2008
    Labeler - Nnodum Pharmaceuticals (960457273)
    Registrant - Nnodum Pharmaceuticals (960457273)
    Establishment
    Name Address ID/FEI Business Operations
    Catalent Australia PTY LTD 753617638 ANALYSIS(63044-622), MANUFACTURE(63044-622)
    Establishment
    Name Address ID/FEI Business Operations
    Banner Pharmacaps 242721744 ANALYSIS(63044-622), MANUFACTURE(63044-622)
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