STROVITE ONE  CAPLETS- vitamin a, calcium pantothenate, ascorbic acid, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, biotin, cyanocobalamin, selenium, magnesium oxide, zinc oxide, cupric sulfate, manganese, chromium, .alpha.-lipoic acid, and lutein tablet 
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.

----------

STROVITE® ONE

0642-0207-90

Iron Free Multivitamin and Mineral Supplement

Rx

COMPOSITION

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 acid1 mg
Vitamin B12 (as cyanocobalamin)50 mcg
Biotin100 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 Acid7.5 mg
Lutein5 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

INDICATIONS AND USAGE

STROVITE® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.

CONTRAINDICATIONS

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).

WARNING/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.

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

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.

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.

ADVERSE REACTIONS

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in STROVITE® ONE.

DOSAGE AND ADMINISTRATION

One caplet daily or as directed by a physician.

HOW SUPPLIED

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.

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

PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label

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
STROVITE ONE   CAPLETS
vitamin a, calcium pantothenate, ascorbic acid, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, biotin, cyanocobalamin, selenium, magnesium oxide, zinc oxide, cupric sulfate, manganese, chromium, .alpha.-lipoic acid, and lutein tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0207
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A3000 [iU]
Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737, Calcium Cation - UNII:2M83C4R6ZB) Pantothenic Acid7.5 mg
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid300 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol1000 [iU]
.Alpha.-Tocopherol Succinate, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .Alpha.-Tocopherol Succinate, D-100 [iU]
Thiamine (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J) Thiamine20 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin5 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide25 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride25 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin100 ug
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin50 ug
Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium100 ug
Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Cation50 mg
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 mg
Cupric Sulfate (UNII: LRX7AJ16DT) (Cupric Cation - UNII:8CBV67279L) Cupric Cation1.5 mg
Manganese (UNII: 42Z2K6ZL8P) (Manganese - UNII:42Z2K6ZL8P) Manganese1.5 mg
Chromium (UNII: 0R0008Q3JB) (Chromium - UNII:0R0008Q3JB) Chromium50 ug
THIOCTIC ACID (UNII: 73Y7P0K73Y) (THIOCTIC ACID - UNII:73Y7P0K73Y) THIOCTIC ACID15 mg
Lutein (UNII: X72A60C9MT) (Lutein - UNII:X72A60C9MT) Lutein5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
STARCH, CORN (UNII: O8232NY3SJ)  
SOYBEAN OIL (UNII: 241ATL177A)  
TALC (UNII: 7SEV7J4R1U)  
SUCROSE (UNII: C151H8M554)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM ASCORBATE (UNII: S033EH8359)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize19mm
FlavorImprint Code EV0207
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0642-0207-9090 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2001
2NDC:0642-0207-031 in 1 BOX05/04/2001
23 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER05/04/2001
Labeler - Exeltis USA, Inc. (071170534)

Revised: 4/2018
Document Id: 8663684d-d90d-451c-af1d-02b7201e9dd8
Set id: b9b71fa4-89c7-4f5b-8174-950649434ba5
Version: 2
Effective Time: 20180406
 
Exeltis USA, Inc.