Strovite ®

Strovite ®
SPL v5
SPL
SPL Set ID b9b71fa4-89c7-4f5b-8174-950649434ba5
Route
ORAL
Published
Effective Date 2021-11-05
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Manganese (1.5 mg) Vitamin A (900 ug) Calcium Cation (7.5 mg) Ascorbic Acid (300 mg) Cholecalciferol (25 ug) .alpha.-tocopherol, D- (45 ug) Thiamine Ion (20 mg) Riboflavin (5 mg) Niacinamide (25 mg) Pyridoxine (1700 ug) Folic Acid (100 ug) Biotin (50 ug) Cyanocobalamin (50 mg) Selenium (15 mg) Magnesium Cation Zinc Oxide Cupric Cation Chromium Alpha Lipoic Acid Lutein
Inactive Ingredients
Hydroxypropyl Methylcellulose Maltodextrin Stearic Acid Mannitol Croscarmellose Sodium Microcrystalline Cellulose Silicon Dioxide Titanium Dioxide Magnesium Stearate Polyvinyl Alcohol, Unspecified Starch, Corn Talc Sucrose Polyethylene Glycol, Unspecified Anhydrous Dibasic Calcium Phosphate Tocopherol Sodium Ascorbate .alpha.-tocopherol, Dl- Modified Corn Starch (1-octenyl Succinic Anhydride) Corn Oil

Identifiers & Packaging

Pill Appearance
Imprint: EV0207 Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2001-05-04

Description

0642-0207-90 STROVITE ® ONE IRON FREE MULTIVITAMIN AND MINERAL SUPPLEMENT Rx

Indications and Usage

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

Dosage and Administration

One caplet daily or as directed by a physician.

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).

Adverse Reactions

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

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.

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).


Medication Information

Indications and Usage

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

Dosage and Administration

One caplet daily or as directed by a physician.

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).

Adverse Reactions

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

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.

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).

Description

0642-0207-90 STROVITE ® ONE IRON FREE MULTIVITAMIN AND MINERAL SUPPLEMENT Rx

Section 42229-5

0642-0207-90

STROVITE ® ONE

IRON FREE MULTIVITAMIN AND MINERAL

SUPPLEMENT

Rx

Section 44425-7

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

Composition
Each caplet contains:
Vitamin A (as beta carotene) 900 mcg RAE
Vitamin C 300 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
Biotin 100 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 Acid 7.5 mg
Lutein 5 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.

Pediatric Use

Not recommended for pediatric use.

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.

Information for Patients

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

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


Structured Label Content

Section 42229-5 (42229-5)

0642-0207-90

STROVITE ® ONE

IRON FREE MULTIVITAMIN AND MINERAL

SUPPLEMENT

Rx

Section 44425-7 (44425-7)

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

Composition (COMPOSITION)
Each caplet contains:
Vitamin A (as beta carotene) 900 mcg RAE
Vitamin C 300 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
Biotin 100 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 Acid 7.5 mg
Lutein 5 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.

How Supplied (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).

Pediatric Use

Not recommended for pediatric use.

Adverse Reactions (ADVERSE REACTIONS)

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

Contraindications (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).

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.

Warning/precautions (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.

Indications and Usage (INDICATIONS AND USAGE)

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

Information for Patients

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

Dosage and Administration (DOSAGE AND ADMINISTRATION)

One caplet daily or as directed by a physician.

Principal Display Panel 90 Caplet Bottle Label (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


Advanced Ingredient Data


Raw Label Data

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