ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in STROVITE(R) ONE.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. STROVITE(R) 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).

DESCRIPTION SECTION.

COMPOSITION. Each caplet contains:Vitamin (as ascorbic acid)300 mgVitamin D3 (as cholecalciferol)25 mcgVitamin (as d-alpha tocopheryl succinate)45 mcgVitamin B1 (as thiamine HCl)20 mgVitamin B2 (as riboflavin)5 mgNiacinamide (Vitamin B3)25 mg NEVitamin B6 (as pyridoxine HCl)25 mgFolate (as Folic acid)1700 mcg DFEVitamin B12 (as cyanocobalamin)50 mcgBiotin100 mcgPantothenic Acid (as ca pantothenate)15 mgMagnesium (as magnesium oxide)50 mgZinc (as zinc oxide)25 mgSelenium (as sodium selenate)100 mcgCopper (as cupric sulfate)1.5 mgManganese (as manganese sulfate)1.5 mgChromium (as chromic chloride)50 mcgCarotenoids (alpha-carotene, beta-carotene, cryptoxanthin, lutein, zeaxanthin)900 mcgAlpha Lipoic Acid7.5 mgLutein5 mgOther 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.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. One caplet daily or as directed by physician.

DRUG INTERACTIONS SECTION.

Drug Interactions. High doses of folic acid may result in decreased serum levels of anticonvulsant drugs.Vitamin 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 hours apart to minimize interactions.Consult appropriate references for additional specific vitamin-drug interactions.

HOW SUPPLIED SECTION.

HOW SUPPLIED. STROVITE(R) ONE is 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 15-30C (59-86F). Avoid excessive heat and moisture.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. STROVITE(R) ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.

INFORMATION FOR PATIENTS SECTION.

Information for Patients. Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 90 Caplet Bottle Label. 0642-0207-90Strovite(R) ONEIRON FREEMULTIVITAMINANDMINERAL SUPPLEMENTGLUTEN AND LACTOSE FREE90 CapletsRx. PRINCIPAL DISPLAY PANEL 90 Caplet Bottle Label.

PEDIATRIC USE SECTION.

Pediatric Use. Not recommended for pediatric use.

PRECAUTIONS SECTION.

Drug Interactions. High doses of folic acid may result in decreased serum levels of anticonvulsant drugs.Vitamin 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 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 breastfeeding.. Pediatric Use. Not recommended for pediatric use.

SPL UNCLASSIFIED SECTION.

0642-0207-90Iron Free Multivitamin and Mineral SupplementRx.

STORAGE AND HANDLING SECTION.

Store at room temperature 15-30C (59-86F). Avoid excessive heat and moisture.

WARNINGS AND PRECAUTIONS SECTION.

WARNING/PRECAUTIONS. Vitamin 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 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 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.Avoid Over dosage. Keep out of the reach of children.