Vitafol Ultra Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
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.
Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
There is currently no drug history available for this drug.
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|
(as Folic acid USP 0.4 mg and L-methylfolate Calcium 0.6 mg, as Metafolin® CAS# 151533-22-1)
|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*|
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.