Label: VITAFOL PLUS- omega-3 fatty acids, niacin, .alpha.-tocopherol, vitamin d, lauric acid, vitamin a, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, iron, zinc, copper, iodine, magnesium, and folic acid capsule, liquid filled
Contains inactivated NDC Code(s)
NDC Code(s): 0642-0092-01, 0642-0092-30
- Packager: Everett Laboratories, 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 April 18, 2012
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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
INDICATIONS AND USAGE
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)
- BOXED WARNING (What is this?)
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.
Information for Patients
Patients should be counseled to disclose all medical conditions, including pregnancy and breast-feeding, and the use of all medications and dietary supplements.
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.
- DOSAGE AND ADMINISTRATION
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.
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- PRINCIPAL DISPLAY PANEL - 30 Capsule Carton
INGREDIENTS AND APPEARANCE
omega-3 fatty acids, niacin, .alpha.-tocopherol, vitamin d, lauric acid, vitamin a, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, iron, zinc, copper, iodine, magnesium, and folic acid capsule, liquid filled
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-0092 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Omega-3 Fatty Acids (UNII: 71M78END5S) (Doconexent - UNII:ZAD9OKH9JC) Omega-3 Fatty Acids 200 mg Niacin (UNII: 2679MF687A) (Niacinamide - UNII:25X51I8RD4) Niacin 15 mg .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 10 [iU] Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D 1000 [iU] Lauric Acid (UNII: 1160N9NU9U) (Lauric Acid - UNII:1160N9NU9U) Lauric Acid 60 mg Vitamin A (UNII: 81G40H8B0T) (.Beta.-Carotene - UNII:01YAE03M7J) Vitamin A 1100 [iU] Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 12 mg Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine - UNII:X66NSO3N35) Thiamine Mononitrate 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 12 ug Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 27 mg Zinc (UNII: J41CSQ7QDS) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc 15 mg Copper (UNII: 789U1901C5) (Cupric Oxide - UNII:V1XJQ704R4) Copper 2 mg Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 200 ug Magnesium (UNII: I38ZP9992A) (Magnesium Oxide - UNII:3A3U0GI71G) Magnesium 5 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Inactive Ingredients Ingredient Name Strength Gelatin (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 Yellow No. 5 (UNII: I753WB2F1M) FD&C Red No. 40 (UNII: WZB9127XOA) FD&C Blue No. 1 (UNII: H3R47K3TBD) Sunflower Oil (UNII: 3W1JG795YI) Tocopherol (UNII: R0ZB2556P8) Ascorbyl Palmitate (UNII: QN83US2B0N) Product Characteristics Color PURPLE Score no score Shape OVAL Size 12mm Flavor Imprint Code EV0092 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0642-0092-30 5 in 1 BOX 1 6 in 1 BLISTER PACK 2 NDC:0642-0092-01 1 in 1 BOX 2 4 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/23/2012 Labeler - Everett Laboratories, Inc. (071170534) Establishment Name Address ID/FEI Business Operations Interge Pharmaceutical, Inc, 964464114 MANUFACTURE Establishment Name Address ID/FEI Business Operations Blispak Acquisition Corporation 194902235 PACK Establishment Name Address ID/FEI Business Operations Nutra-Med Packaging, Inc 022004902 PACK