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
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated October 11, 2019
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- SPL UNCLASSIFIED SECTION
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
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.
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).
- BOXED WARNING (What is this?)
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.
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.
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.
- DIRECTIONS FOR USE
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.
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- PRINCIPAL DISPLAY PANEL - 30 Tablet Dose Pack Carton
INGREDIENTS AND APPEARANCE
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 (1600000 WAMW) (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)