VIRT VITE GT- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide and docusate  tablet 
Virtus Pharmaceuticals OpCo II

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Virt-Vite GT

Prenatal/Postnatal Prescription Dietary Supplement

76439-270-90

Rx

DESCRIPTION

Virt-Vite GT is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

DIRECTIONS FOR USE

One tablet daily with or without food or as prescribed by a licensed medical practitioner.

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving% Daily Value for Pregnant & Lactating Women
*
Daily Value not established
Vitamin A (beta carotene)2700 IU34%
Vitamin C (ascorbic acid)120 mg200%
Vitamin D (vitamin D3 as cholecalciferol)400 IU100%
Vitamin E (di-alpha tocopheryl acetate)10 IU33%
Vitamin B1 (thiamine mononitrate)3 mg176%
Vitamin B2 (riboflavin)3.4 mg170%
Niacinamide20 mg100%
Vitamin B6 (pyridoxine HCl)20 mg800%
Folic Acid1 mg125%
Vitamin B12 (cyanocobalamin)12 mcg150%
Biotin30 mcg10%
Pantothenic Acid6 mg60%
Calcium (calcium carbonate)200 mg15%
Elemental Iron (carbonyl iron)90 mg500%
Magnesium (magnesium oxide)30 mg7%
Zinc (zinc oxide)15 mg100%
Copper (cupric oxide)2 mg100%
Docusate Sodium50 mg*

Other Ingredients: Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate.

KEEP THIS OUT OF REACH OF CHILDREN

CONTRAINDICATIONS

This product is contraindicated for persons with known hypersensitivity to any of its components.

Products containing iron should not be used during dimercaprol therapy.

This product should not be used with laxatives.

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.

CAUTION

High levels of folic acid may, especially in older adults, hide signs of vitamin B-12 deficiency (such as pernicious anemia, a condition that can cause nerve damage).

SIDE EFFECTS

Hypersensitivity side effects have been reported rarely for folic acid. They have included erythema, rash, pruritis, malaise, dyspnea with bronchospasm.

Thiamine mononitrate and riboflavin do not produce side effects. Riboflavin may cause urine to become more yellow than usual.

Oral pyridoxine is considered to be safe. Hypersensitivity, photosensitivity, and allergic dermatitis have been reported rarely.

Orally administered vitamin B12 has no reported side effects.

Carbonyl Iron side effects are most frequently reported to be gastrointestinal. They have included diarrhea, cramping, nausea, constipation, heartburn, and epigastric discomfort. Other side effects have included iron overload (hemosiderosis) and stained teeth. Headaches have been reported occasionally.

In the Virt-Vite GT formulation, zinc oxide is considered to be safe; It has been reported to be "probably safe" when as much as 40 mg per day is ingested. Zinc oxide overdose causes gastrointestinal distress; abdominal pain, nausea, bloating, gas, and diarrhea may occur. Fever and chills can also signify inappropriate exposure.

DRUG INTERACTIONS

Ascorbic acid may decrease the effects of amphetamine. Preliminary data suggest that ascorbic acid may diminish the antitumor effects of bortezomib when taken simultaneously.

Riboflavin absorption can be increased by concurrent use of anticholinergic drugs. The clinical significance of this has not been determined.

Pyridoxine alters the duration of response to the antineoplastic drug altretamine. Some antiepileptic medications, including valproic acid, carbamazepine, phenobarbital, and phenytoin increase the catabolism rate of vitamin B6 resulting in hyperhomocysteinemia. The action of levodopa is potentiated by pyridoxine.

Folic acid has been reported to potentiate the pharmacologic effects of 5-fluorouracil (5-FU) (and its prodrugs capecitabine and tegafur) especially if prescribed in combination with leucovorin. Co-administration with folate therapy may reduce the anticonvulsant effects of phenytoin, phenobarbital, primidone, and succinimides.

Carbonyl iron is known to interact with dolutegravir (may decrease the oral bioavailability). Dimercaprol can bind with iron, forming a complex that is toxic to the kidneys. Carbonyl iron may decrease the absorption of tetracycline antibiotics, fluoroquinolone antibiotics, levodopa, methyldopa, levothyroxine products, or penicillamine.

Orally administered zinc oxide may interfere with the absorption of quinolone or tetracycline antibiotics.

SPECIFIC POPULATIONS

This product is formulated specifically for pregnant or nursing women.

HEALTH CLAIM

Adequate folate in healthful diets may reduce a woman's risk of having a child with a brain or spinal cord birth defect.

HOW SUPPLIED

Supplied as oval, light purple-coated tablets debossed with "V270" dispensed in boxes of 90 tablets (9 × 10 blister packs).

STORAGE

Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and moisture.

Notice: Contact with moisture may produce surface discoloration or erosion.

Call your licensed medical practitioner about side effects. You may report side effects by calling Virtus at 1-855-255-6076 or FDA at 1-800-FDA-1088.

Rx

Manufactured for
Virtus Pharmaceuticals OPCO II, LLC
Nashville, TN 37217
1-855-255-6076

MADE IN USA
Rev. 8/2015

PRINCIPAL DISPLAY PANEL - 90 Tablet Blister Pack Carton

VIRTUS
PHARMACEUTICALS OPCO II

76439-270-90

Virt-Vite GT

PRENATAL/POSTNATAL

Prescription Dietary Supplement

SAFETY SEALED:
DO NOT USE IF BLISTER SEAL IS BROKEN

Rx
90 Tablets

(9 x 10 Blister Packs)

Made in the USA

Principal Display Panel - 90 Tablet Blister Pack Carton
VIRT VITE GT 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide and docusate tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-270
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE2700 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-10 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE20 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID6 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON90 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE30 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-270-9010 in 1 CARTON
19 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT07/29/201302/09/2017
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)19 mm
imprint
Labeler - Virtus Pharmaceuticals OpCo II (969483143)

Revised: 10/2017
 
Virtus Pharmaceuticals OpCo II