Strovite One

Name: Strovite One

STROVITE® ONE Iron Free Multivitamin and Mineral Supplement

Rx

Indications and Usage for Strovite One

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

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 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.

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.

PRINCIPAL DISPLAY PANEL - 3 Caplet Unit Dose Pack Carton

SAMPLE NOT FOR SALE
0642-0207-03

Iron Free
Strovite® ONE Caplets
Multivitamin and Mineral Supplement

• ONE THOUSAND (1000 IU VITAMIN D3)
• ONE CAPLET DAILY
• FOLIC ACID
• LUTEIN
• VITAMIN C
• ZINC
• SELENIUM

The
All-in-ONE
prescription
multivitamin

UNIT DOSE PACK
3 Caplets

U.S. PATENTED

RX
GLUTEN AND LACTOSE FREE

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 Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0642-0207
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (Vitamin A) Vitamin A 3000 [iU]
Calcium Pantothenate (Pantothenic Acid and Calcium Cation) Pantothenic Acid 15 mg
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 300 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 1000 [iU]
.Alpha.-Tocopherol Succinate, D- (.ALPHA.-TOCOPHEROL, D-) .Alpha.-Tocopherol Succinate, D- 100 [iU]
Thiamine (Thiamine Ion) Thiamine 20 mg
Riboflavin (Riboflavin) Riboflavin 5 mg
Niacinamide (Niacinamide) Niacinamide 25 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Biotin (Biotin) Biotin 100 ug
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 50 ug
Selenium (Selenium) Selenium 100 ug
Magnesium Oxide (Magnesium Cation) Magnesium Cation 50 mg
Zinc Oxide (Zinc Oxide) Zinc Oxide 25 mg
Cupric Sulfate (Cupric Cation) Cupric Cation 1.5 mg
Manganese (Manganese) Manganese 1.5 mg
Chromium (Chromium) Chromium 50 ug
.Alpha.-Lipoic Acid (.Alpha.-Lipoic Acid) .Alpha.-Lipoic Acid 15 mg
Lutein (Lutein) Lutein 5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
Cellulose, Microcrystalline  
SILICON DIOXIDE  
TITANIUM DIOXIDE  
GELATIN  
MAGNESIUM STEARATE  
POLYVINYL ALCOHOL  
STARCH, CORN  
SOYBEAN OIL  
TALC  
SUCROSE  
ETHYLCELLULOSES  
POLYETHYLENE GLYCOLS  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
ASCORBYL PALMITATE  
TOCOPHEROL  
SODIUM ASCORBATE  
MEDIUM-CHAIN TRIGLYCERIDES  
.ALPHA.-TOCOPHEROL, DL-  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code EV0207
Contains     
Packaging
# Item Code Package Description
1 NDC:0642-0207-90 90 TABLET in 1 BOTTLE
2 NDC:0642-0207-03 1 BLISTER PACK in 1 BOX
2 3 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/04/2001
Labeler - Everett Laboratories, Inc. (071170534)
Revised: 09/2014   Everett Laboratories, Inc.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Hard stools (constipation).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Strovite One may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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