The following Structured Product Label (SPL) was submitted to the FDA by Everett Laboratories, Inc. for the product Vitafol (NDC 0642-0092). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, composition, other ingredients, indications and usage, contraindications, warning, warning/precautions, drug interactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Rx only
Rx only
Manufactured for
EVERETT LABORATORIES, INC.
West Orange, NJ 07052
1-877-324-9349
Patent Pending
Vitafol® is a trademark of Everett Laboratories, Inc.
life's DHA is a trademark of DSM.
U.S. Patent No. 5,492,938; 7,163,811
(Rev. 03/12)
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.
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.
Vitafol®-Plus 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 B-12)
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.
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.
Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol®-Plus. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.
Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.
Vitafol®-Plus is available as a purple, oval shaped softgel capsule imprinted EV0092. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules) (NDC0642-0092-30), and as professional samples (NDC0642-0092-01). Store at room temperature, approximately 15°-30°C (59°-86°F). Avoid excessive heat, moisture and protect from light.
NDC 0642-0092-30
Vitafol®-Plus
Prenatal Supplement with DHA
Small, All-In-One,
Once Daily Softgel Capsule
EV0092
Actual Size
DOES NOT CONTAIN
FISH OIL
life's DHA
HEALTHY BRAIN, EYES, HEART™
Unit Dose Pack
30 Softgel Capsules
Rx only
Patent Pending
Principal Display Panel (30 Capsule Carton)
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