STROVITE FORTE CAPLET- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, pantothenic acid, magnesium, zinc, selenium, copper, chromium, molybdenum, and iron tablet, coated
Exeltis USA, Inc.
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.
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STROVITE ® FORTE
| Each STROVITE ® FORTE caplet contains: | Amount Per Serving | % Daily Value |
|---|---|---|
| Vitamin A (acetate and beta carotene) | 4000 IU | 80% |
| Vitamin C (ascorbic acid) | 500 mg | 833% |
| Vitamin D3 (cholecalciferol) | 400 IU | 100% |
| Vitamin E (dl-alpha-tocopheryl acetate) | 60 IU | 200% |
| Vitamin B1 (thiamine mononitrate) | 20 mg | 1333% |
| Vitamin B2 (riboflavin) | 20 mg | 1176% |
| Niacinamide (vitamin B3) | 100 mg | 500% |
| Vitamin B6 (pyridoxine HCl) | 25 mg | 1250% |
| Folic Acid | 1.0 mg | 250% |
| Vitamin B12 (cyanocobalamin) | 50 mcg | 833% |
| Biotin | 0.15 mg | 50% |
| Pantothenic acid (calcium pantothenate) | 25 mg | 250% |
| Iron (ferrous fumarate) | 10 mg | 56% |
| Magnesium (magnesium oxide) | 50 mg | 13% |
| Zinc (zinc oxide) | 15 mg | 100% |
| Selenium (sodium selenate) | 50 mcg | 71% |
| Copper (cupric oxide) | 3 mg | 150% |
| Chromium (chromium nitrate) | 50 mcg | 42% |
| Molybdenum (sodium molybdate) | 20 mcg | 27% |
OTHER INGREDIENTS: Microcrystalline Cellulose, Starch, Maltodextrin, Stearic Acid, Dicalcium Phosphate, Hypromellose, Crospovidone, Polyvinylpyrrolidone, Croscarmellos Sodium, Sodium Lauryl Sulfate, Gelatin, Titanium Dioxide, Citric Acid, Soy Polysaccharide, Talc, Magnesium Stearate, Sucrose, Polyethylene Glycol, Mineral Oil, FD&C Yellow #5 Lake (Tartrazine as a color additive), Silica, FD&C Blue #1 Lake, Sodium Ascorbate, Tocopherols, Triglycerides, Tricalcium Phosphate, Ascorbyl Palmitat and BHT. Contains: Soy
INDICATION AND USAGE
STROVITE ® FORTE provides nutritional supplementation to support optimum vitamin and mineral levels.
CONTRAINDICATIONS
STROVITE ® FORTE is contraindicated in patients hypersensitive to any of its components. Folic Acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12).
WARNING
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
WARNINGS/PRECAUTIONS
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. 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 Over dosage. Keep out of the reach of children.
Drug Interactions
As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of Parkinsonism. Therefore, STROVITE® FORTE is not recommended for patients undergoing such therapy.
High doses of folic acid may result in decreased serum levels of 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 calciumcontaining 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
Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in STROVITE ® FORTE. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
HOW SUPPLIED
Dark green, oblong, bisect caplets; embossed "EV 0204". Available in bottles of 100 caplets, 0642-0204-10. Store at controlled room temperature 15°-30°C (59°- 86°F). Avoid excessive heat. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
| STROVITE FORTE
CAPLET
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, pantothenic acid, magnesium, zinc, selenium, copper, chromium, molybdenum, and iron tablet, coated |
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| Labeler - Exeltis USA, Inc. (071170534) |
| Registrant - Exeltis USA, Inc. (071170534) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Exeltis USA, Inc. | 071170534 | label(0642-0204) | |