The following Structured Product Label (SPL) was submitted to the FDA by Exeltis Usa, Inc. for the product Strovite One (NDC 0642-0207). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, composition, indications and usage, contraindications, warning/precautions, drug interactions, information for patients, pediatric use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
0642-0207-90
Iron Free Multivitamin and Mineral Supplement
Rx
Rx
Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349
www.exeltisusa.com
©2018 Exeltis USA, Inc.
US Patent No. 6,863,904
Strovite® is a trademark of Exeltis USA, Inc.
Rev. January 2018
2079001-01
| Each caplet contains: | ||
| Vitamin C (as ascorbic acid) | 300 mg | |
| Vitamin D3 (as cholecalciferol) | 1000 IU | |
| Vitamin E (as d-alpha tocopheryl succinate) | 100 IU | |
| Vitamin B1 (as thiamine HCl) | 20 mg | |
| Vitamin B2 (as riboflavin) | 5 mg | |
| Niacinamide (Vitamin B3) | 25 mg | |
| Vitamin B6 (as pyridoxine HCl) | 25 mg | |
| Folic acid | 1 mg | |
| Vitamin B12 (as cyanocobalamin) | 50 mcg | |
| Biotin | 100 mcg | |
| Pantothenic Acid (as ca pantothenate) | 15 mg | |
| Magnesium (as magnesium oxide) | 50 mg | |
| Zinc (as zinc oxide) | 25 mg | |
| Selenium (as sodium selenate) | 100 mcg | |
| Copper (as cupric sulfate) | 1.5 mg | |
| Manganese (as manganese sulfate) | 1.5 mg | |
| Chromium (as chromic chloride) | 50 mcg | |
| Carotenoids (alpha-carotene, beta-carotene, cryptoxanthin, lutein, zeaxanthin) | 3000 IU | |
| Alpha Lipoic Acid | 7.5 mg | |
| Lutein | 5 mg | |
Other Ingredients: Dibasic calcium phosphate, microcrystalline cellu-lose, carbohydrate, croscarmellose sodium, stearic acid, gelatin, polyvinyl alcohol, silicon dioxide, titanium dioxide (as color), polyethylene glycol, sucrose, magnesium stearate, modified food starch, soybean oil, talc, ethylcellulose, ascorbyl palmitate, mixed tocophererols, sodium ascorbate, medium chain triglycerides, dl-alpha-tocopherol.
Contains: Soy
STROVITE® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.
STROVITE® ONE is contraindicated in patients with hypersensitivity 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).
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.
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.
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 hyper-calcemia 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.
Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding.
Not recommended for pediatric use.
Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in STROVITE® ONE.
One caplet daily or as directed by a physician.
STROVITE® ONE is a white, oblong caplet, debossed EV0207; available in bottles of 90 caplets. 0642-0207-90 and as professional samples (0642-0207-03).
Store at room temperature 15°-30°C (59°-86°F). Avoid excessive heat and moisture.
0642-0207-90
Strovite®ONE
IRON FREE
MULTIVITAMIN
AND
MINERAL SUPPLEMENT
GLUTEN AND LACTOSE FREE
90 Caplets
Rx
Principal Display Panel (90 Caplet Bottle Label)
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