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Strovite One Caplets Package Insert

Updated:
Facts
Status:
Prescription (Rx)
Strength:
1.5 mg, 900 mcg, 7.5 mg, 300 mg, 25 mcg, 45 mcg, 20 mg, 5 mg, 25 mg, 25 mg, 1700 mcg, 100 mcg, 50 mcg, 100 mcg, 50 mg, 25 mg, 1.5 mg, 50 mcg, 15 mg, 5 mg

Prescribing information (package insert) - Strovite One Caplets

0642-0207-90

STROVITE ® ONE

IRON FREE MULTIVITAMIN AND MINERAL

SUPPLEMENT

Rx

COMPOSITION

Each caplet contains:
Vitamin A (as beta carotene)900 mcg RAE
Vitamin C300 mg
Vitamin D (as cholecalciferol)25 mcg
Vitamin E (as d-alpha tocopheryl succinate)67 mg
Thiamin (as thiamine hydrochloride)20 mg
Riboflavin (vitamin B2)5 mg
Niacin (as niacinamide)25 mg NE
Vitamin B6 (as pyridoxine hydrochloride)25 mg
Folate (as folic acid)1,670 mcg DFE
Vitamin B12 (as cyanocobalamin)50 mcg
Biotin100 mcg
Pantothenic Acid (as calcium-D-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 chromium chloride)50 mcg
Alpha Lipoic Acid7.5 mg
Lutein5 mg

Other ingredients: Microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin E alcohol, sodium ascorbate, mannitol.

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 overdosage. 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).

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

KEEP OUT OF REACH OF CHILDREN.

Rx

MANUFACTURED IN THE USA

Distributed by:

Exeltis USA, Inc.

Florham Park, NJ 07932

1-877-324-9349

www.exeltisusa.com

©2022 Exeltis USA, Inc. All rights reserved.

US PATENT NO. 6,863,904

STROVITE ® ONE is a trademark of Exeltis Healthcare S.L.

Rev. 10/2022 2079003-04

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: October 2022

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Strovite One Caplets

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Calculi Dissolution Agent, Osmotic Laxative, Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Manganese 1.5 mg, Vitamin A 900 mcg, Calcium pantothenate 7.5 mg, Ascorbic acid 300 mg, Cholecalciferol 25 mcg, Alpha-tocopherol succinate, D- 45 mcg, Thiamine 20 mg, Riboflavin 5 mg, Niacinamide 25 mg, Pyridoxine hydrochloride 25 mg, Folic acid 1700 mcg, Biotin 100 mcg, Cyanocobalamin 50 mcg, Selenium 100 mcg, Magnesium oxide 50 mg, Zinc oxide 25 mg, Cupric sulfate 1.5 mg, Chromium 50 mcg, Alpha lipoic acid 15 mg, Lutein 5 mg
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) Exeltis USA, Inc.
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
1.5 mg, 900 mcg, 7.5 mg, 300 mg, 25 mcg, 45 mcg, 20 mg, 5 mg, 25 mg, 25 mg, 1700 mcg, 100 mcg, 50 mcg, 100 mcg, 50 mg, 25 mg, 1.5 mg, 50 mcg, 15 mg, 5 mg – 90 in 1 bottle NDC 0642-0207-90
1.5 mg, 900 mcg, 7.5 mg, 300 mg, 25 mcg, 45 mcg, 20 mg, 5 mg, 25 mg, 25 mg, 1700 mcg, 100 mcg, 50 mcg, 100 mcg, 50 mg, 25 mg, 1.5 mg, 50 mcg, 15 mg, 5 mg – 3 in 1 blister pack / 1 in 1 box NDC 0642-0207-03

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.