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, take one softgel capsule by mouth daily, or as directed by a physician.
www.exeltisusa.comAmount per Capsule:
| VITAMINS AND MINERALS: | |
|---|---|
| Vitamin A (as beta carotene) | 330 mcg RAE |
| Vitamin C (as ascorbic acid) | 30 mg |
| Vitamin D (as cholecalciferol) | 25 mcg |
| Vitamin E (as dl-alpha tocopheryl acetate) | 9 mg |
| Thiamin (Vitamin B1 as thiamine mononitrate) | 1.6 mg |
| Riboflavin (Vitamin B2) | 1.8 mg |
| Niacin (as niacinamide) | 15 mg NE |
| Vitamin B6 (as pyridoxine hydrochloride) | 2.5 mg |
| Folate
(680 mcg DFE from folic acid & 1020 mcg DFE from l-methylfolate calcium) | 1700 mcg DFE |
| Vitamin B12 (as cyanocobalamin) | 12 mcg |
| Iron (as polysaccharide iron complex) | 29 mg |
| Iodine (as potassium iodide) | 150 mcg |
| Magnesium (as magnesium oxide) | 20 mg |
| Zinc (as zinc oxide) | 25 mg |
| Copper (as copper oxide) | 2 mg |
Docosahexaenoic acid (DHA) (from natural algal oil) | 200 mg |
Other Ingredients:
Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue #1, Ethyl Vanillin. Titanium Dioxide (color). May contain: Sunflower Oil, Olive Oil.
Contains: Soy.
Vitafol ® Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*
Vitafol ® Ultra does not contain fish, fish oils, fish proteins or fish byproducts.
Vitafol ® Ultra 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.
Vitafol ® Ultra contains soy and should be used with caution in patients with known sensitivity or allergy to soy.
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.
Iodine should be used with caution in patients with an overactive thyroid.
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.
Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.
Medications for hypertension used in conjunction with iodine supplementation may increase potassium.
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.
Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.
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.
Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ® Ultra. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.
You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349.
Before, during and after pregnancy, take one softgel capsule by mouth daily, or as directed by a physician.
Vitafol ® Ultra is available as a dark blue, oval shaped softgel capsule imprinted "EV0093". Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules) (0642-0093-30) and as professional samples (0642- 0093-03).
Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.
| *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. |
Rx
Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349
www.exeltisusa.com
©2024 Exeltis USA, Inc. All rights reserved.
Vitafol
® is a trademark of Exeltis Healthcare S.L.
U.S. Patent No. 8,183,227
Rev. July 2024
0933001-04
0642-0093-30
V
®
VITAFOL
ULTRA
Prenatal Supplement with 200mg DHA
Unit Dose Pack
30 Softgel Capsules
R
x
DIETARY SUPPLEMENT
U.S. PATENTED
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| LEVOMEFOLIC ACID Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20230428 |
| MAGNESIUM CATION Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0642-0093-03 | VitafolUltra | 4 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 4 | 9 | |
| 0642-0093-03 | VitafolUltra | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 9 | |
| 0642-0093-30 | VitafolUltra | 5 in 1 BOX | CAPSULE, LIQUID FILLED | 5 | 9 | |
| 0642-0093-30 | VitafolUltra | 6 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 6 | 9 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0642-0093 | VITAFOL ULTRA (DOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, .BETA.-CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUM) CAPSULE, LIQUID FILLED [EXELTIS USA, INC.] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250321_40fa2c3a-f41f-434c-91de-5150a18d3e4b.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0642-0093-30 | EA - Each | 0642-0093 | f2163f74-fe58-4c4b-a370-7f9276398dea | 1 | 2013-11-04 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .Alpha.-Tocopherol Acetate, DL- | ACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| .Beta.-Carotene | ACTIVE INGREDIENT | 01YAE03M7J | 1 | |
| Ascorbic Acid | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| Cholecalciferol | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| Cupric Oxide | ACTIVE INGREDIENT | V1XJQ704R4 | 1 | |
| Cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| Doconexent | ACTIVE INGREDIENT | ZAD9OKH9JC | 1 | |
| Folic Acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Iron | ACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| Levomefolate Calcium | ACTIVE INGREDIENT | A9R10K3F2F | 1 | |
| Magnesium Oxide | ACTIVE INGREDIENT | 3A3U0GI71G | 1 | |
| Niacinamide | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| Potassium Iodide | ACTIVE INGREDIENT | 1C4QK22F9J | 1 | |
| Pyridoxine Hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| Riboflavin | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| Thiamine Mononitrate | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| .Alpha.-Tocopherol, DL- | ACTIVE MOIETY | 7QWA1RIO01 | 1 | |
| .Beta.-Carotene | ACTIVE MOIETY | 01YAE03M7J | 1 | |
| Ascorbic Acid | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| Cholecalciferol | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| Cupric Cation | ACTIVE MOIETY | 8CBV67279L | 1 | |
| Cyanocobalamin | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| Doconexent | ACTIVE MOIETY | ZAD9OKH9JC | 1 | |
| Folic Acid | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| Iodide Ion | ACTIVE MOIETY | 09G4I6V86Q | 1 | |
| Iron | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| Levomefolic Acid | ACTIVE MOIETY | 8S95DH25XC | 1 | |
| Magnesium Cation | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| Niacinamide | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| Pyridoxine | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| Riboflavin | ACTIVE MOIETY | TLM2976OFR | 1 | |
| Thiamine Ion | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .Alpha.-Tocopherol, DL- | INACTIVE INGREDIENT | 7QWA1RIO01 | 1 | |
| Ascorbyl Palmitate | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| Corn Oil | INACTIVE INGREDIENT | 8470G57WFM | 1 | |
| Ethyl Vanillin | INACTIVE INGREDIENT | YC9ST449YJ | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Lecithin, Soybean | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| Soybean Oil | INACTIVE INGREDIENT | 241ATL177A | 1 | |
| Sunflower Oil | INACTIVE INGREDIENT | 3W1JG795YI | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Tocopherol | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Yellow Wax | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0642-0093 | 0642-0093-30, 0642-0093-03 |
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 |
|---|---|---|---|---|---|---|
| Sorbitol | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| .Alpha.-Tocopherol, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | TABLET, CHEWABLE / ORAL | 0.02 mg | ||
| Ethyl Vanillin | ETHYL VANILLIN | YC9ST449YJ | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| Corn Oil | CORN OIL | 8470G57WFM | TABLET, DELAYED RELEASE / ORAL | 0.03 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| Yellow Wax | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| Corn Oil | CORN OIL | 8470G57WFM | TABLET, COATED / ORAL | 10 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| Yellow Wax | YELLOW WAX | 2ZA36H0S2V | TABLET, DELAYED RELEASE / ORAL | 0.1 mg | ||
| Yellow Wax | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| Yellow Wax | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| Corn Oil | CORN OIL | 8470G57WFM | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| .Alpha.-Tocopherol, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | TABLET / ORAL | 0.12 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| Corn Oil | CORN OIL | 8470G57WFM | SUSPENSION, EXTENDED RELEASE / ORAL | 10 mg | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| .Alpha.-Tocopherol, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | TABLET, CHEWABLE / ORAL | 0.02 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| Corn Oil | CORN OIL | 8470G57WFM | TABLET / ORAL | 20 mg | ||
| .Alpha.-Tocopherol, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | TABLET, CHEWABLE / ORAL | 0.02 mg | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | POWDER, FOR SUSPENSION / ORAL | 39 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| Yellow Wax | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| Yellow Wax | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| .Alpha.-Tocopherol, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| Sorbitol | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| Sorbitol | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| Ethyl Vanillin | ETHYL VANILLIN | YC9ST449YJ | CAPSULE / ORAL | 0.64 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| Corn Oil | CORN OIL | 8470G57WFM | TABLET, CHEWABLE / ORAL | NA | ||
| .Alpha.-Tocopherol, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| Ethyl Vanillin | ETHYL VANILLIN | YC9ST449YJ | CAPSULE / ORAL | 0.64 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| Ethyl Vanillin | ETHYL VANILLIN | YC9ST449YJ | PASTE / ORAL | 7 mg | ||
| Soybean Oil | SOYBEAN OIL | 241ATL177A | CAPSULE / ORAL | 1318 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA | ||
| Ethyl Vanillin | ETHYL VANILLIN | YC9ST449YJ | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| .Alpha.-Tocopherol, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | SOLUTION / ORAL | 4 mg | ||
| Corn Oil | CORN OIL | 8470G57WFM | TABLET, DELAYED RELEASE / ORAL | 0.03 mg | ||
| Corn Oil | CORN OIL | 8470G57WFM | CAPSULE / ORAL | 918 mg |
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 |
|---|---|---|---|---|---|---|
| Vitafol Ultra | DOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, .BETA.-CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUM | Exeltis USA, Inc. | 40fa2c3a-f41f-434c-91de-5150a18d3e4b | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | 0642-0093-30 0642-0093-03 0642-0093 00642009303 00642009330 303eca3e-0bc8-1bf8-e063-6294a90a82d8 40fa2c3a-f41f-434c-91de-5150a18d3e4b |
Adverse event summaries are temporarily unavailable. Other product information remains available.