VIRT NATE- folic acid, thiamine mononitrate, cupric oxide, riboflavin, cyanocobalamin, niacinamide, .alpha.-tocopherol acetate, dl-, zinc cation, pyridoxine hydrochloride, magnesium oxide, ferrous fumarate, ascorbic acid, calcium carbonate, cholecalciferol and .beta.-carotene  tablet 
Virtus Pharmaceuticals LLC

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Virt Nate Tablets

STATEMENT OF IDENTITY: Virt Nate Tablets is an orally administered PRENATAL / POSTNATAL prescription folate specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.

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.

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a licensed medical practitioner.

Each white tablet contains the following dietary ingredients:
Folic Acid 1 mg
Thiamin (Vitamin B1) 1.8 mg
Copper (as cupric oxide) 2 mg
Riboflavin (Vitamin B2) 4 mg
Vitamin B12 (cyanocobalamin) 12 mcg
Niacin (niacinamide)20 mg
Vitamin E (dl-alpha tocopheryl acetate) 22 mg
Zinc (as zinc oxide) 25 mg
Vitamin B6 (Pyridoxine HCl) 25 mg
Magnesium (as magnesium oxide) 25 mg
Iron (ferrous fumarate) 28 mg
Vitamin C (ascorbic acid) 120 mg
Calcium (calcium carbonate)200 mg
Vitamin D (as cholecalciferol) 400 IU
Vitamin A (beta carotene) 3000 IU

Other Ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide, Stearic acid, HPMC 15cp,Polydextrose, PEG 4000, Titanium Dioxide and other ancillary ingredients as needed to ensure product stability.

How Supplied: Virt Nate is supplied as white tablets debossed on one side with "V264", dispensed in bottles of 100 tablets.

PRECAUTIONS/WARNING: Caution is recommended in patients with a history of bipolar illness as mood elevation is possible following coadministration of folate with antidepressant therapy. Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group.Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.

STORAGE: Store at Controlled Room Temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.

HEALTH CLAIMS: Prescription Vitamin B Containing Dietary Supplement

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VIRTUS
PHARMACEUTICALS

NDC 76439-264-10

Virt Nate
Tablets

Prenatal/Postnatal
Prescription Folate

Rx      100 Tablets

PRINCIPAL DISPLAY PANEL - 30 tablets
VIRT NATE 
folic acid, thiamine mononitrate, cupric oxide, riboflavin, cyanocobalamin, niacinamide, .alpha.-tocopherol acetate, dl-, zinc cation, pyridoxine hydrochloride, magnesium oxide, ferrous fumarate, ascorbic acid, calcium carbonate, cholecalciferol and .beta.-carotene tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-264
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.8 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN4 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-22 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION25 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION28 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE3000 [iU]
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-264-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT07/29/201307/30/2017
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)19 mm
imprint
Labeler - Virtus Pharmaceuticals LLC (969483143)

Revised: 10/2017
 
Virtus Pharmaceuticals LLC