FDA Label for Vitafol Ultra
View Indications, Usage & Precautions
Vitafol Ultra Product Label
The following document was submitted to the FDA by the labeler of this product Exeltis Usa, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Rx
Rx
Manufactured for
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349
www.exeltisUSA.com
@2015 Exeltis USa, Inc.
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
Vitafol® is a trademark of Exeltis USA, Inc.
U.S. Patent No. 8,183,227
Life's DHA™ is a trademark of DSM.
U.S. Patent No. 7,163,811 and 7,824,892
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
and 7,674,490
Rev. October 2015
Composition
Amount per Capsule:
| VITAMINS AND MINERALS: | |||
|---|---|---|---|
| Vitamin A (as beta carotene) | 1100 | IU | |
| Vitamin C (as ascorbic acid) | 30 | mg | |
| Vitamin D (as cholecalciferol) | 1000 | IU | |
| Vitamin E (as dl-alpha tocopheryl acetate) | 20 | IU | |
| Thiamin (Vitamin B1) | 1.6 | mg | |
| Riboflavin (Vitamin B2) | 1.8 | mg | |
| Niacin (as niacinamide) | 15 | mg | |
| 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 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 | |
| Algal oil blend (derived from crypthecodinium cohnii, CAS# 1258273-84-5) | 415 | mg (providing 200 mg DHA (docosahexaenoic acid)) |
Other Ingredients
Gelatin (bovine BSE-free), Sorbitol, Glycerin, Soybean Oil, Yellow Beeswax, USP Purified Water, Lecithin, FD&C Blue #1, Titanium Dioxide (color), Ethyl Vanillin. May contain: Corn Oil, dl-alpha tocopherol, High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate.
Contains: Soy.
Usage
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, including individuals with known allergies to fish. Vitafol®-Ultra does not contain fish, fish oils, fish proteins or fish byproducts.
Contraindications
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).
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.
Warnings/Precautions
Vitafol®-Ultra contains soy and lactose and should be used with caution in patients with known sensitivity or allergy to soy or lactose.
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.
Drug Interactions
Medications for an overactive thyroid (antithyroid 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.
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
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.
Directions For Use
Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.
How Supplied
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, 0642-0093-01
Storage And Handling
Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, light and moisture.
Principal Display Panel - 30 Softgel Blister Pack Box
0642-0093-30
V™
VITAFOL
ULTRA
Prenatal Supplement with 200mg DHA
Unit Dose Pack
30 Softgel Capsules
RX
DIETARY SUPPLEMENT
U.S. PATENTED
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