Label: VITAFOL NANO- cholecalciferol, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, iron, and iodine tablet, coated

  • NDC Code(s): 0642-0094-03, 0642-0094-30
  • Packager: Exeltis USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated March 20, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • BOXED WARNING(What is this?)

    WARNING

    Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately,

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  • SPL UNCLASSIFIED SECTION

    Rx

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  • COMPOSITION

    Amount per Tablet:

    VITAMINS AND MINERALS

    Vitamin D (as cholecalciferol) 1000 IU
    Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg
    Folate (as Folic acid USP 0.4 mg and L-methylfolate calcium 0.6 mg, as Metafolin® CAS# 151533-22-1) 1 mg
    Vitamin B12 (as cyanocobalamin) 12 mcg
    Iron (as ferrous fumarate) 18 mg
    Iodine (as potassium iodide) 150 mcg

    Other Ingredients

    Microcrystalline cellulose, hydroxypropylcellulose, modified food starch, croscarmellose sodium, magnesium stearate, sucrose, silicon dioxide, dibasic calcium phosphate, polyvinyl alcohol, titanium dioxide (as color), polyethylene glycol, talc, sodium ascorbate, medium chain triglycerides, dl-alpha-tocopherol, sucralose, FD&C Blue #2 Aluminum Lake.

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  • USAGE

    Vitafol®-Nano provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.

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  • CONTRAINDICATIONS

    Vitafol®-Nano is contraindicated in patients with hypersensitivity to any of its components or color additives.

    Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.

    Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

    Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).

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  • WARNINGS/PRECAUTIONS

    Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.

    Prolonged use of iron salts may produce iron storage disease.

    Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

    The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.

    Avoid Overdosage. Keep out of the reach of children.

    DRUG INTERATIONS

    High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease a patient's response to methotrexate.

    Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

    Consult appropriate references for additional specific vitamin-drug interactions.

    Information for Patients

    Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding.

    Pediatric Use

    Not for pediatric use.

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  • ADVERSE REACTIONS

    Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol®-Nano. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

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  • DIRECTIONS FOR USE

    Before, during and after pregnancy, one tablet daily, or as directed by a physician.

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  • HOW SUPPLIED

    Vitafol®-Nano is available as a light blue, round tablet imprinted with "94" on one side. Available in Box of Unit-Dose pack of 30 (2 child resistant blister cards of 15 tablets), 0642-0094-30 and as professional samples, 0642-0094-03.

    Store at Controlled room temperature at 20°-25°C (68°-77°F). Avoid exessive heat, light, moisture and humidity.

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  • SPL UNCLASSIFIED SECTION

    Rx

    Distributed by:
    Exeltis USA, Inc.
    Florham Park, NJ 07932
    1-877-324-9349
    www.exeltisusa.com
    ©2017 Exeltis USA, Inc

    Metafolin® is a trademark of Merck KGaA, Darmstadt, Germany

    U.S. Patent No. 6,441,168B1; 5,997,915; 6,254,904; 6,808,725; 7,172,778 and 7,674,490

    Rev. June 2017
    0943001-01

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  • PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Box

    0642-0094-30

    VITAFOL
    Nano

    Smallest Prenatal Supplement
    with essential nutrients

    Unit Dose Pack / 30 Tablets

    Rx
    DIETARY SUPPLEMENT

    PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Box
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  • INGREDIENTS AND APPEARANCE
    VITAFOL   NANO
    cholecalciferol, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, iron, and iodine tablet, coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-0094
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) CHOLECALCIFEROL 1000 [iU]
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 2.5 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 0.4 mg
    Levomefolate Calcium (UNII: A9R10K3F2F) (Levomefolic Acid - UNII:8S95DH25XC) Levomefolate Calcium 0.6 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 12 ug
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 18 mg
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 150 ug
    Inactive Ingredients
    Ingredient Name Strength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCROSE (UNII: C151H8M554)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code EV0094
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0642-0094-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/14/2014
    2 NDC:0642-0094-03 3 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/14/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 07/14/2014
    Labeler - Exeltis USA, Inc. (071170534)
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