Label: VITAFOL ONE- prenatal supplement with dha capsule, gelatin coated
- NDC Code(s): 0642-0070-01, 0642-0070-30
- Packager: Everett Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated August 16, 2021
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- SPL UNCLASSIFIED SECTION
- providing 200DHA (docosahexaenoic acid)
COMPOSITION: Each Softgel Capsule Contains: VITAMINS AND MINERALS: Vitamin A (as Vitamin A palmitate) 330 mcg RAE Vitamin C (as ascorbic acid) 30 mg Vitamin D3 (as cholecalciferol) 25 mcg Vitamin E (as dl-alpha tocopheryl acetate) 9 mg Thiamine mononitrate (Vitamin B1) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 12 mcg Elemental 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 natural algal oil) 415 mg*
Gelatin (Bovine BSE-free), Sorbitol, Glycerin, Soybean Oil, USP Purified Water, Yellow Beeswax, Dicalcium Phosphate, Soy Lecithin, Vegetable Oil, FD&C Blue #1, Titanium Dioxide (color), Sodium Thiosulfate, Caramel (color), High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate. Contains: Soy.
INDICATIONS AND USAGE
Vitafol-One 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-One does not contain fish, fish oils, fish proteins or fish byproducts.
Vitafol-One 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-One 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, 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; taken 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 have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol-One. 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-One is available as a dark blue, oval shaped softgel capsule imprinted "EV0070". Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules), (0642-0070-30) and as professional samples (0642-0070-03).
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 Capsule Blister Pack Carton
INGREDIENTS AND APPEARANCE
prenatal supplement with dha capsule, gelatin coated
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-0070 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A 330 ug Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 30 mg Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.6 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.8 mg Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin 15 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine 2.5 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin .012 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1700 ug Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 0.150 mg Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium 20 mg Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 25 mg Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper 2 mg Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D 25 ug Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids 200 mg .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 9 mg Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 29 mg Inactive Ingredients Ingredient Name Strength Gelatin, Unspecified (UNII: 2G86QN327L) Sorbitol (UNII: 506T60A25R) Glycerin (UNII: PDC6A3C0OX) Soybean Oil (UNII: 241ATL177A) Water (UNII: 059QF0KO0R) Yellow Wax (UNII: 2ZA36H0S2V) Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J) Lecithin, Soybean (UNII: 1DI56QDM62) Titanium Dioxide (UNII: 15FIX9V2JP) Sodium Thiosulfate (UNII: HX1032V43M) Sunflower Oil (UNII: 3W1JG795YI) Tocopherol (UNII: R0ZB2556P8) Ascorbyl palmitate (UNII: QN83US2B0N) Caramel (UNII: T9D99G2B1R) FD&C Blue NO. 1 (UNII: H3R47K3TBD) Corn Oil (UNII: 8470G57WFM) Product Characteristics Color blue (Dark Blue) Score no score Shape OVAL (size 12 Oval Capsule) Size 10mm Flavor Imprint Code EV0070 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0642-0070-30 5 in 1 BOX 06/13/2011 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0642-0070-01 1 in 1 BOX 06/13/2011 2 4 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/13/2011 Labeler - Everett Laboratories, Inc. (071170534)