STROVITE FORTE CAPLET- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, pantothenic acid, magnesium, zinc, selenium, copper, chromium, molybdenum, and iron tablet, coated

Strovite Forte by

Drug Labeling and Warnings

Strovite Forte by is a Prescription medication manufactured, distributed, or labeled by Exeltis USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Supplemental Facts
Serving Size: 1 Caplet

DESCRIPTION

Each STROVITE® FORTE caplet contains:	Amount Per Serving	% Daily Value
Vitamin A (acetate and beta carotene)	4000 IU	80%
Vitamin C (ascorbic acid)	500 mg	833%
Vitamin D3 (cholecalciferol)	400 IU	100%
Vitamin E (dl-alpha-tocopheryl acetate)	60 IU	200%
Vitamin B1 (thiamine mononitrate)	20 mg	1333%
Vitamin B2 (riboflavin)	20 mg	1176%
Niacinamide (vitamin B3)	100 mg	500%
Vitamin B6 (pyridoxine HCl)	25 mg	1250%
Folic Acid	1.0 mg	250%
Vitamin B12 (cyanocobalamin)	50 mcg	833%
Biotin	0.15 mg	50%
Pantothenic acid (calcium pantothenate)	25 mg	250%
Iron (ferrous fumarate)	10 mg	56%
Magnesium (magnesium oxide)	50 mg	13%
Zinc (zinc oxide)	15 mg	100%
Selenium (sodium selenate)	50 mcg	71%
Copper (cupric oxide)	3 mg	150%
Chromium (chromium nitrate)	50 mcg	42%
Molybdenum (sodium molybdate)	20 mcg	27%

OTHER INGREDIENTS: Microcrystalline Cellulose, Starch, Maltodextrin, Stearic Acid, Dicalcium Phosphate, Hypromellose, Crospovidone, Polyvinylpyrrolidone, Croscarmellos Sodium, Sodium Lauryl Sulfate, Gelatin, Titanium Dioxide, Citric Acid, Soy Polysaccharide, Talc, Magnesium Stearate, Sucrose, Polyethylene Glycol, Mineral Oil, FD&C Yellow #5 Lake (Tartrazine as a color additive), Silica, FD&C Blue #1 Lake, Sodium Ascorbate, Tocopherols, Triglycerides, Tricalcium Phosphate, Ascorbyl Palmitat and BHT. Contains: Soy

INDICATION AND USAGE

STROVITE® FORTE provides nutritional supplementation to support optimum vitamin and mineral levels.

CONTRAINDICATIONS

STROVITE® FORTE is contraindicated in patients hypersensitive 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).

BOXED WARNING

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WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

WARNINGS/PRECAUTIONS

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.

PRECAUTIONS

Drug Interactions

As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of Parkinsonism. Therefore, STROVITE® FORTE is not recommended for patients undergoing such therapy.

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.

ADVERSE REACTIONS

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in STROVITE® FORTE. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

DOSAGE AND ADMINISTRATION

Usual adult dosage: one caplet daily.

HOW SUPPLIED

Dark green, oblong, bisect caplets; embossed "EV 0204". Available in bottles of 100 caplets, 0642-0204-10. Store at controlled room temperature 15°-30°C (59°- 86°F). Avoid excessive heat. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

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Rx

Manufactured for:
EVERETT LABORATORIES, INC.
Chatham, NJ 07928

You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information contact 1-877-324-9349

Rev. 12/13

Strovite® is a trademark of Everett Laboratories, Inc.

PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Label

0642-0204-10

STROVITE® FORTE

MULTIVITAMIN AND MINERAL
SUPPLEMENT

100 Caplets

Rx

INGREDIENTS AND APPEARANCE

STROVITE FORTE   CAPLET
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, pantothenic acid, magnesium, zinc, selenium, copper, chromium, molybdenum, and iron tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0642-0204
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T)	Vitamin A	4000 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	500 mg
Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41)	Vitamin D	400 [iU]
.Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1)	.Alpha.-Tocopherol	60 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	20 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	20 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A)	Niacin	100 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	25 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	50 ug
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04)	Biotin	0.15 mg
Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737)	Pantothenic Acid	25 mg
Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A)	Magnesium	50 mg
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS)	Zinc	15 mg
Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B)	Selenium	50 ug
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5)	Copper	3 mg
Chromium (UNII: 0R0008Q3JB) (Chromium - UNII:0R0008Q3JB)	Chromium	50 ug
Molybdenum (UNII: 81AH48963U) (Molybdenum - UNII:81AH48963U)	Molybdenum	20 ug
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	10 mg

Inactive Ingredients
Ingredient Name	Strength
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Stearic Acid (UNII: 4ELV7Z65AP)
Croscarmellose Sodium (UNII: M28OL1HH48)
Crospovidone (UNII: 68401960MK)
Calcium Phosphate, Dibasic, Anhydrous (UNII: L11K75P92J)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Starch, Corn (UNII: O8232NY3SJ)
Maltodextrin (UNII: 7CVR7L4A2D)
Hypromelloses (UNII: 3NXW29V3WO)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Lecithin, Soybean (UNII: 1DI56QDM62)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Magnesium Stearate (UNII: 70097M6I30)
Titanium Dioxide (UNII: 15FIX9V2JP)
Povidone K30 (UNII: U725QWY32X)
Polyethylene Glycols (UNII: 3WJQ0SDW1A)
Mineral Oil (UNII: T5L8T28FGP)
Gelatin (UNII: 2G86QN327L)
Talc (UNII: 7SEV7J4R1U)
Sucrose (UNII: C151H8M554)
Sodium Ascorbate (UNII: S033EH8359)
Tocopherol (UNII: R0ZB2556P8)
C10-18 Triglycerides (UNII: 43AGM4PHPI)
Tricalcium Phosphate (UNII: K4C08XP666)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
FD&C Yellow no. 5 (UNII: I753WB2F1M)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN (Dark Green)	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	EV0204
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0642-0204-10	100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/01/1996

Labeler - Everett Laboratories, Inc. (071170534)