Indications and uses
Vitafol ® is indicated to provide vitamin, mineral supplementation to support optimum vitamin levels.
Vitafol
- Manufacturer
- Exeltis USA, Inc.
- Effective date
- 2023-01-09
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:41:17
Label at a glance#
ProductVitafol Caplet
Active ingredientVITAMIN A, ASCORBIC ACID, VITAMIN D, .ALPHA.-TOCOPHEROL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, IRON
Label structure10 sections
Dosage and administration
One caplet daily, preferably after a meal or as prescribed by a physician.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Rx
COMPOSITION
| Each caplet contains: | |
| Vitamin A (as acetate) | 6000 IU |
| Vitamin C (as ascorbic acid) | 60 mg |
| Vitamin D-3 (as cholecalciferol) | 400 IU |
| Vitamin E (as d-alpha tocopheryl acetate) | 30 IU |
| Thiamine Mononitrate | 1.1 mg |
| Vitamin B-2 (as riboflavin) | 1.8 mg |
| Niacinamide (Vitamin B-3) | 15 mg |
| Pyridoxine HCl | 2.5 mg |
| Folic Acid | 1 .0 mg |
| Vitamin B-12 (as cyanocobalamin) | 5 mcg |
| Calcium (as calcium carbonate) | 125 mg |
| Iron (as ferrous fumarate) | 65 mg |
Other Ingredients: Microcrystalline Cellulose, Stearic Acid, Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, Silica, Acacia, Maltodextrin, Hypromellose, Citric Acid, Soy Polysaccharide, Sodium Lauryl Sulfate, Magnesium Stearate, Titanium Dioxide, Magnesium Silicate, Gum Arabic, Polyethylene Glycol, Mineral Oil, Polyvinylpyrrolidone, FD&C Red #40 Lake, D&C Red #27 Lake and FD&C Blue #1 Lake. Contains Soy.
INDICATIONS AND USAGE
Vitafol ® is indicated to provide vitamin, mineral supplementation to support optimum vitamin levels.
CONTRAINDICATIONS
Vitafol ® 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 B-12).
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 therapeutic use of iron salts may produce iron storage disease.
WARNING
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.
SPL UNCLASSIFIED SECTION
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 Interactions
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.
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 breast-feeding.
Pediatric Use
Not for pediatric use.
ADVERSE REACTIONS
Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ®.
DOSAGE AND ADMINISTRATION
One caplet daily, preferably after a meal or as prescribed by a physician.
HOW SUPPLIED
Vitafol ® is available as a pink, capsule shaped caplet, debossed EV0072. Available in box of unit dose pack of 100 (0642-0072-12).
STORAGE AND HANDLING SECTION
Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, moisture and protect from light.
SPL UNCLASSIFIED SECTION
Rx only
Manufactured for
EVERETT LABORATORIES, INC.
Chatham, NJ 07928
1-877-324-9349
Vitafol
® is a trademark of Everett Laboratories, Inc.
(Rev. 12/13)
PRINCIPAL DISPLAY PANEL - 100 Caplet Carton
0642-0072-12
VITAFOL ®
Multivitamin Supplement
10 X 10 UNIT DOSE PACK
100 CAPLETS
R x
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0642-0072-12 | 2023-01-09 | C162847 | 48780-1 | 9d75b9d0-741d-f424-e053-dadaa90a57ce | VITAFOL ® Multivitamin and Mineral Supplement |
| 0642-0072-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-741d-f424-e053-dadaa90a57ce | VITAFOL ® Multivitamin and Mineral Supplement |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0642-0072-12 | EA - Each | 0642-0072 | 5bf141f6-3d40-4cfc-8e48-b8b9708bcb69 | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .Alpha.-Tocopherol | ACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| Ascorbic Acid | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| Calcium | ACTIVE INGREDIENT | SY7Q814VUP | 1 | |
| Cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| Folic Acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Iron | ACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| Niacin | ACTIVE INGREDIENT | 2679MF687A | 1 | |
| Pyridoxine Hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| Riboflavin | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| Thiamine Mononitrate | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| Vitamin A | ACTIVE INGREDIENT | 81G40H8B0T | 1 | |
| Vitamin D | ACTIVE INGREDIENT | 9VU1KI44GP | 1 | |
| .Alpha.-Tocopherol | ACTIVE MOIETY | H4N855PNZ1 | 1 | |
| Ascorbic Acid | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| Calcium | ACTIVE MOIETY | SY7Q814VUP | 1 | |
| Cholecalciferol | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| Cyanocobalamin | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| Folic Acid | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| Iron | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| Niacin | ACTIVE MOIETY | 2679MF687A | 1 | |
| Pyridoxine | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| Riboflavin | ACTIVE MOIETY | TLM2976OFR | 1 | |
| Thiamine Ion | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| Vitamin A | ACTIVE MOIETY | 81G40H8B0T | 1 | |
| Acacia | INACTIVE INGREDIENT | 5C5403N26O | 1 | |
| Calcium Phosphate, Dibasic, Anhydrous | INACTIVE INGREDIENT | L11K75P92J | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | 1 | |
| D&C Red No. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| Lecithin, Soybean | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| Maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| Mineral Oil | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| Povidone K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Sodium Lauryl Sulfate | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Vitafol Caplet
- Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, and Iron
- CELLULOSE, MICROCRYSTALLINE
- STEARIC ACID
- CROSCARMELLOSE SODIUM
- CROSPOVIDONE
- CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
- SILICON DIOXIDE
- ACACIA
- MALTODEXTRIN
- HYPROMELLOSES
- CITRIC ACID MONOHYDRATE
- LECITHIN, SOYBEAN
- SODIUM LAURYL SULFATE
- MAGNESIUM STEARATE
- TITANIUM DIOXIDE
- MINERAL OIL
- POVIDONE K30
- FD&C RED NO. 40
- D&C RED NO. 27
- FD&C BLUE NO. 1
- VITAMIN A
- ASCORBIC ACID
- VITAMIN D
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL
- THIAMINE MONONITRATE
- THIAMINE ION
- THIAMINE
- RIBOFLAVIN
- NIACIN
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- FOLIC ACID
- CYANOCOBALAMIN
- CALCIUM
- IRON
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0642-0072 | 0642-0072-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 385 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | SHAMPOO / TOPICAL | 65 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM / SUBLINGUAL | 10 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / AURICULAR (OTIC) | 0.2 %w/v | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| Povidone K30 | POVIDONE K30 | U725QWY32X | TABLET, ORALLY DISINTEGRATING / ORAL | 71 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO / TOPICAL | 17 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| Povidone K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EXTENDED RELEASE / ORAL | 45 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| Acacia | ACACIA | 5C5403N26O | TABLET, CHEWABLE / ORAL | 121 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAVENOUS | 10 mg | ||
| Povidone K30 | POVIDONE K30 | U725QWY32X | GRANULE / ORAL | 202 mg | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FOR SUSPENSION / ORAL | 264 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| Acacia | ACACIA | 5C5403N26O | TABLET / BUCCAL | 9.1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, FILM COATED / ORAL | 42 mg | ||
| Acacia | ACACIA | 5C5403N26O | SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | GEL / RECTAL | 348 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / VAGINAL | 0.49 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / BUCCAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| Calcium Phosphate, Dibasic, Anhydrous | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | PASTE, DENTIFRICE / DENTAL | 48.36 %w/w | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| Calcium Phosphate, Dibasic, Anhydrous | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | POWDER / SUBLINGUAL | 30 mg | ||
| D&C Red No. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| f1df21f2-c8ef-5ddd-e053-2995a90a379b | d4713072-1864-40ce-b003-a171fb2bc127 | 2023-01-09 | Boxed warning, Adverse reactions | f1df21f2-c8ef-5ddd-e053-2995a90a379b d4713072-1864-40ce-b003-a171fb2bc127 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.