FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Vitafol-Plus 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.
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.
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs carbamazepine, fosphenytoin, phenytoin, phenobarbitol, and 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 pregnancy and breast-feeding, and the use of all medications and dietary supplements.
Not for Pediatric Use.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
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.
Uses
Vitafol®-Plus is indicated to provide vitamin, mineral and omega-3 fatty acid 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®-Plus does not contain fish, fish oils, fish proteins or fish byproducts.
History
There is currently no drug history available for this drug.
Other Information
Each Softgel Capsule Contains:
Vitamins and Minerals: | |
---|---|
Vitamin A (as beta carotene) | 1100 IU |
Vitamin C (as ascorbic acid) | 12 mg |
Vitamin D3 (as cholecalciferol) | 1000 IU |
Vitamin E (as dl-alpha tocopheryl acetate) | 10 IU |
Thiamin (Vitamin B1) (as thiamine mononitrate) | 1.6 mg |
Riboflavin (Vitamin B2) | 1.8 mg |
Niacin (as nicotinamide) | 15 mg |
Vitamin B6 (as pyridoxine hydrochloride) | 2.5 mg |
Folic Acid | 1 mg |
Vitamin B12 (as cyanocobalamin) | 12 mcg |
Elemental Iron (as polysaccharide iron complex) | 27mg |
Iodine (as potassium iodide) | 200 mcg |
Magnesium (as magnesium oxide) | 5 mg |
Zinc (as zinc oxide) | 15 mg |
Copper (as copper oxide) | 2 mg |
Lauric Acid | 60 mg |
Omega-3 FATTY ACID | |
DHA from Algal (crypthecodinium) Oil | 200 mg |
Gelatin, Sorbitol, Glycerin, Soybean Oil, USP Purified Water, Yellow Beeswax, Soy Lecithin, FD&C Blue #1, Titanium Dioxide (color), High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate, FD&C Yellow #5, FD&C Red #40.
Sources
Vitafol Plus Manufacturers
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Everett Laboratories, Inc.
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