Label: VITAFOL-OB PLUS DHA PRENATAL SUPPLEMENT PLUS DHA- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, copper, and doconexent kit
- NDC Code(s): 0642-0076-30
- Packager: Everett Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated August 9, 2021
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Each Vitafol®-OB caplet contains:
- (providing 250 mg DHA (docosahexaenoic acid))
Vitamin A (as beta carotene) 810 mcg RAE Vitamin C (as ascorbic acid) 70 mg Vitamin D3 (as cholecalciferol) 10 mcg Vitamin E (as dl-alpha tocopheryl acetate) 13.5 mg Thiamine mononitrate (Vitamin B1) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 18 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 12 mcg Calcium (as calcium carbonate) 100 mg Iron (as ferrous fumarate) 65 mg Magnesium (as magnesium oxide) 25 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Each DHA softgel capsule contains: 486 mg* Algal oil blend (derived from Natural Algal Oil)
SPL UNCLASSIFIED SECTION
Other Ingredients in Vitafol®-OB caplet: Microcrystalline Cellulose, hydrolyzed gelatin (pig skin), modified cellulose gum, stearic acid, hydroxypropylmethylcellulose, titanium dioxide (as color), polydextrose, silicon dioxide, gelatin, magnesium stearate, modified food starch, sucrose, maize starch, triacetin, dibasic calcium phosphate, hydroxypropylcellulose, FD&C Blue #1 Aluminum Lake, polyethylene glycol, sodium ascorbate, tocopherol concentrate, FD&C Blue #2 Aluminum Lake, medium chain trglycerides, sorbic acid, tribasic calcium phosphate, sodium benzoate, dl-alpha-tocopherol. Contains: Soy
Other Ingredients in DHA softgel capsule: Gelatin, Glycerin USP, Water.
INDICATIONS AND USAGE
Vitafol®-OB+DHA 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®-OB+DHA does not contain fish, fish oils, fish proteins or fish byproducts.
Vitafol®-OB+DHA 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?)
Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathryroidism 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.
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.
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.
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
- Pediatric Use
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
VITAFOL®-OB+DHA is available as a light blue caplet debossed EV0079 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (6 child resistant blister cards of 5 caplets and 5 softgel capsules each), (0642-0076-30) and as professional samples (0642-0076-03).
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- PRINCIPAL DISPLAY PANEL - Kit Carton
INGREDIENTS AND APPEARANCE
VITAFOL-OB PLUS DHA PRENATAL SUPPLEMENT PLUS DHA
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, copper, and doconexent kit
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-0076 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0642-0076-30 1 in 1 CARTON 02/16/2007 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOX 30 Part 2 1 BOX 30 Part 1 of 2 VITAFOL-OB
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, and copper tablet, coated
Product Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A 810 ug Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 70 mg Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D 10 ug .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 13.5 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 18 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 2.5 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1700 ug Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 12 ug Calcium (UNII: SY7Q814VUP) (Calcium - UNII:SY7Q814VUP) Calcium 100 mg Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 65 mg Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium 25 mg Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 25 mg Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper 2 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Stearic Acid (UNII: 4ELV7Z65AP) Croscarmellose Sodium (UNII: M28OL1HH48) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) Silicon Dioxide (UNII: ETJ7Z6XBU4) Modified Corn Starch (1-Octenyl Succinic Anhydride) (UNII: 461P5CJN6T) Sucrose (UNII: C151H8M554) Starch, Corn (UNII: O8232NY3SJ) Sodium Ascorbate (UNII: S033EH8359) Tocopherol (UNII: R0ZB2556P8) Magnesium Stearate (UNII: 70097M6I30) Titanium Dioxide (UNII: 15FIX9V2JP) Acacia (UNII: 5C5403N26O) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Sorbic Acid (UNII: X045WJ989B) Tricalcium Phosphate (UNII: K4C08XP666) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Polydextrose (UNII: VH2XOU12IE) Triacetin (UNII: XHX3C3X673) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) FD&C Blue No. 1 (UNII: H3R47K3TBD) FD&C Blue No. 2 (UNII: L06K8R7DQK) D&C Yellow No. 10 (UNII: 35SW5USQ3G) Aluminum Oxide (UNII: LMI26O6933) Product Characteristics Color BLUE Score no score Shape OVAL Size 19mm Flavor Imprint Code EV;0079 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOX; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/16/2007 Part 2 of 2 DHA
Product Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 250 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) WATER (UNII: 059QF0KO0R) Product Characteristics Color YELLOW (Amber) Score no score Shape OVAL Size 15mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOX; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 02/16/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/16/2007 Labeler - Everett Laboratories, Inc. (071170534)