NDC | 0642-0079-08, 0642-0079-12 |
Set ID | 22828f24-600d-4aa6-9b3a-cf8c991f9a97 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Exeltis USA, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- Rx only
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COMPOSITION
Each Caplet contains:
VITAMINS AND MINERALS: Vitamin A (as beta carotene) 2700 IU Vitamin C (as ascorbic acid) 70 mg Vitamin D3 (as cholecalciferol) 400 IU Vitamin E (as dl-alpha tocopheryl acetate) 30 IU Thiamine mononitrate (Vitamin B1) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 18 mg Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folic acid 1.0 mg 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 Other Ingredients: Microcrystalline Cellulose, Gelatin, Sodium Croscarmellose, Stearic Acid, Gum Acacia, Silicon Dioxide, Magnesium Stearate, Modified Food Starch, Sucrose, Silicon Dioxide, Maize Starch, Dicalcium Phosphate, Sodium Ascorbate, Tocopherol Concentrate, Medium Chain Triglycerides, Sorbic Acid, Tricalcium Phosphate, dl-Alpha-Tocopherol. Coating: Hypromellose, Titanium Dioxide, Polydextrose, Triacetin, Hydroxypropyl Cellulose, FD&C Blue #1 / Aluminum Lake, Polyethylene Glycol, FD&C Blue #2 / Aluminum Lake, FD&C Yellow #10 Aluminum Lake.
Contains: Soy - INDICATIONS AND USAGE
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CONTRAINDICATIONS
Vitafol®-OB 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?)
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WARNINGS/PRECAUTIONS
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.
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.
Avoid Overdosage. Keep out of the reach of children.
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PRECAUTIONS
DRUG INTERACTIONS
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.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 Caplet Carton
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INGREDIENTS AND APPEARANCE
VITAFOL OB CAPLET
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, and copper tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-0079 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A 2700 [iU] Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 70 mg Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D 400 [iU] .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 30 [iU] 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 1 mg 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) .Alpha.-Tocopherol, DL- (UNII: 7QWA1RIO01) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Polydextrose (UNII: VH2XOU12IE) Triacetin (UNII: XHX3C3X673) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) FD&C Blue No. 1 (UNII: H3R47K3TBD) Aluminum Oxide (UNII: LMI26O6933) FD&C Blue No. 2 (UNII: L06K8R7DQK) D&C Yellow No. 10 (UNII: 35SW5USQ3G) Product Characteristics Color BLUE Score no score Shape OVAL Size 19mm Flavor Imprint Code EV0079 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0642-0079-08 4 in 1 CARTON; Type 0: Not a Combination Product 12/02/2002 2 NDC:0642-0079-12 100 in 1 CARTON; Type 0: Not a Combination Product 12/02/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/02/2002 Labeler - Exeltis USA, Inc. (071170534)