Label: VITAFOL FE PLUS- 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
- NDC Code(s): 0642-7473-30
- Packager: Exeltis USA, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated May 24, 2021
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Each PURPLE softgel capsule contains:
- (providing 200 mg DHA (docosahexaenoic acid))
Vitamin A (as beta carotene) 330 mcg RAE Vitamin C (as ascorbic acid) 60 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as dl-alpha tocopheryl acetate) 9 mg Thiamin (Vitamin B1) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate 1700 mcg DFE (as Folic acid USP 680 mcg DFE; as L-methylfolate calcium 1020 mcg DFE) Vitamin B12 (as cyanocobalamin) 25 mg Iron (as polysaccharide iron complex) 90 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 Algal oil blend (derived from Natural Algal Oil) 415 mg*
Gelatin, Soybean Oil, Sorbitol, Glycerin, Yellow Beeswax, USP Purified Water, Lecithin, Titanium Dioxide (as colorant), FD&C Red #40, FD&C Blue #1, White Edible Ink.
Contains: Soy. May also contain: Corn Oil, DL alpha-tocopherol, Medium ChainTriglycerides.
Vitafol® Fe+ prenatal supplement 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 supplementation 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?)
This product is intended for use as directed by your healthcare provider. Do not share with others. Vitafol® Fe+ must 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.
Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.
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 levels in blood.
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbital, 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.
INFORMATION FOR PATIENTS
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® Fe+. 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® Fe+ is available as a purple, oval shaped softgel capsule imprinted "EX0096". Available in box of Unit-Dose pack of 30 (5 child resistant blister cards containing 6 softgel capsules), Item No. 0642-7473-30 and as professional sample Item No. 0642-7473-01 (blister card containing 3 softgel capsules)
SPL UNCLASSIFIED SECTION
You should call your doctor for medical advice about adverse or unexpected reactions. To report to the company an adverse event or obtain product information, call 1-877-324-9349.
Exeltis USA, Inc.
Florham Park, NJ 07932
©2021 Exeltis USA, Inc.
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.
Vitafol® is a trademark of Exeltis USA, Inc.
Metafolin® is a trademark of Merck KGaA, Darmstadt, Germany. U.S. Patent No. 6,441,168; 5,997,915; 6,254,904; 6,808,725, 7,172,778 and 7,674,490
Issed: April 2021
- PRINCIPAL DISPLAY PANEL - 30 Capsule Dose Pack Box
INGREDIENTS AND APPEARANCE
VITAFOL FE PLUS
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
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-7473 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 200 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 15 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 9 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 25 mg BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE 330 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 60 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.6 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.8 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 2.5 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 25 ug Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 90 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 150 ug MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 20 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 680 mg LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM 1020 ug Inactive Ingredients Ingredient Name Strength GELATIN, UNSPECIFIED (UNII: 2G86QN327L) Sorbitol (UNII: 506T60A25R) Glycerin (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) YELLOW WAX (UNII: 2ZA36H0S2V) Soybean Oil (UNII: 241ATL177A) Lecithin, Soybean (UNII: 1DI56QDM62) Titanium Dioxide (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C Red No. 40 (UNII: WZB9127XOA) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) Ascorbyl Palmitate (UNII: QN83US2B0N) Corn oil (UNII: 8470G57WFM) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Product Characteristics Color PURPLE Score no score Shape OVAL Size 17mm Flavor Imprint Code EV0096 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0642-7473-30 5 in 1 BOX, UNIT-DOSE 03/15/2020 1 6 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 03/15/2020 Labeler - Exeltis USA, Inc. (071170534)