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.
Before, during and after pregnancy, one tablet daily, or as directed by a physician.
www.exeltisusa.comAmount per Tablet:
| Vitamin D (as cholecalciferol) | 25 mcg |
| Vitamin B6 (as pyridoxine hydrochloride) | 2.5 mg |
| Folate
(as Folic acid USP 680 mcg DFE and L-methylfolate calcium 1020 mcg DFE, as Metafolin ® CAS# 151533-22-1) | 1700 mcg DFE |
| 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 provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.
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).
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.
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.
Folate, especially in doses above 1700 mcg DFE (1000 mcg folic acid) 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.
Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
Not for pediatric use.
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.
Before, during and after pregnancy, one tablet daily, or as directed by a physician.
Vitafol ®-Nano is available as a light blue, round tablet imprinted with "94" on one side. Available in 30 cts in HDPE bottle, 0642-0094-01.
Store at room temperature approximately 20°-25°C (68°-77°F). Avoid excessive heat, light, moisture and humidity.
Rx
Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349
www.exeltisusa.com
©2021 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. January 2021
0940101-01
0642-0094-01
VITAFOL
Nano
Smallest Prenatal Supplement with essential nutrients
30 Tablets
R
x
DIETARY SUPPLEMENT
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0642-0094-01 | EA - Each | 0642-0094 | dfe7cceb-e94d-40e1-ba74-4185cc10bfd0 | 1 | 2022-01-06 |
| 0642-0094-30 | EA - Each | 0642-0094 | a00eff40-cb1e-4d4e-afd9-8c3e1d4d4508 | 1 | 2014-08-01 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| Cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| Folic Acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Iodine | ACTIVE INGREDIENT | 9679TC07X4 | 1 | |
| Iron | ACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| Levomefolate Calcium | ACTIVE INGREDIENT | A9R10K3F2F | 1 | |
| Pyridoxine Hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| Cholecalciferol | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| Cyanocobalamin | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| Folic Acid | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| Iodine | ACTIVE MOIETY | 9679TC07X4 | 1 | |
| Iron | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| Levomefolic Acid | ACTIVE MOIETY | 8S95DH25XC | 1 | |
| Pyridoxine | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| .ALPHA.-TOCOPHEROL, DL- | INACTIVE INGREDIENT | 7QWA1RIO01 | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM ASCORBATE | INACTIVE INGREDIENT | S033EH8359 | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0642-0094 | 0642-0094-01, 0642-0094-03 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SOLUTION / OPHTHALMIC | 6 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SPRAY / TOPICAL | 540 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 39.2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET / SUBLINGUAL | 1 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 60 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| SODIUM ASCORBATE | SODIUM ASCORBATE | S033EH8359 | TABLET / ORAL | 30 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SOLUTION / ORAL | 5566 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| .ALPHA.-TOCOPHEROL, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET / ORAL | 165 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM / ORAL | 1 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| TALC | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | GRANULE / ORAL | 13 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| .ALPHA.-TOCOPHEROL, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | TABLET / ORAL | 0.12 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | OINTMENT / TOPICAL | 20 %w/w |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2436ac4d-a27e-11d4-e063-6294a90a4a84 | d4c2b6ae-0a15-435d-bc6c-7443b1306d18 | 2024-10-11 | Boxed warning, Warnings, Adverse reactions | d4c2b6ae-0a15-435d-bc6c-7443b1306d18 |
Adverse event summaries are temporarily unavailable. Other product information remains available.