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

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Virt Nate Tablets

69543-264-10

Rx

PRESCRIPTION PRENATAL / POSTNATAL DIETARY SUPPLEMENT

Prescription Folate

DESCRIPTION

Virt Nate is an orally administered prescription prenatal / postnatal dietary supplement formulated for the dietary management of pregnant and lactating women requiring increased folate levels.

Supplement Facts
Serving Size: 1 Tablet
Amount Per % ServingDaily Value for Pregnant and Lactating Women

Vitamin A (beta carotene)

3000 IU

38%

Vitamin C (ascorbic acid)

120 mg

200%

Vitamin D (Vitamin D3 as cholecalciferol)

400 IU

100%

Vitamin E (dl-alpha tocopheryl acetate)

22 IU

73%

Thiamin (Vitamin B1)

1.8 mg

106%

Riboflavin (Vitamin B2)

4 mg

200%

Niacin (niacinamide)

20 mg

100%

Vitamin B6 (pyridoxine HCl)

25 mg

1000%

Folic Acid

1 mg

125%

Vitamin B12 (cyanocobalamin)

12 mcg

150%

Calcium (calcium carbonate)

200 mg

15%

Iron (ferrous fumarate)

28 mg

156%

Magnesium (magnesium oxide)

25 mg

6%

Zinc (zinc oxide)

25 mg

167%

Copper (cupric oxide)

2 mg

100%

Other Ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide, Stearic Acid, HPMC 15cp, Polydextrose, PEG 4000, and Titanium Dioxide.

ALLERGY STATEMENT

This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion.

Allergic reactions have been reported following the use of oral folate.

KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.

PREGNANCY and NURSING MOTHERS

Virt Nate is intended for use as a prescription folate before, during, and after pregnancy regardless of lactation status.

DIRECTIONS FOR USE

One tablet daily or as directed by a licensed medical practitioner.

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.

SIDE EFFECTS

Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin.

Paresthesia, somnolence, nausea, and headaches have been reported with pyridoxine.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated.

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).

INTERACTIONS

Drugs which may interact with folate include but are not limited to:

First generation anticonvulsants (folate may reduce their effectiveness)
Capecitabine (folate may enhance its toxicity)
Fluorouracil (folate may enhance its toxicity)

Drugs that may interfere with folate metabolism include, but are not limited to:

Dihydrofolate Reductase Inhibitors.
Fluoxetine
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Sulfasalazine
Warfarin

Drugs which may interfere with the absorption of folate from the gastrointestinal tract or decrease plasma levels include, but are not limited to:

Cholestyramine
Colestipol
Oral Contraceptives
Methylprednisolone
Pancreatic Enzymes
Pentamidine
Smoking and Alcohol
Sulfasalazine
Metformin

Drugs which may interact with vitamin B6 include, but are not limited to:

Levodopa (the action of levodopa may be antagonized by vitamin B6)

Drugs which may interact with vitamin B12 include but are not limited to:

Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride (may decrease the absorption of vitamin B12).
Nitrous oxide (can produce a functional vitamin B12 deficiency).

Drugs which may interact with ferrous fumarate include but are not limited to:

Bisphosphonates (may decrease absorption of bisphosphonate)
Dimercaprol (binds to form complex that is nephrotoxic)
Dolutegravir (may decrease absorption of dolutegravir)

Drugs which may interact with zinc oxide include but are not limited to:

Bisphosphonates (may decrease absorption of bisphosphonate)
Quinolone antibiotics (may decrease absorption of quinolone antibiotics)

STORAGE

Store at room temperature 15° to 30°C (59° to 86°F). Protect from light and moisture. Dispense in a tight, light-resistant container.

HOW SUPPLIED

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

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619
1-888-848-3593

MADE IN USA
Rev. 06/2015

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

69543-264-10

Virt-Nate

PRENATAL/POSTNATAL

Prescription Folate-Containing
Dietary Supplement

Rx

100 Tablets
Made in USA

Principal Display Panel - 100 Tablet Bottle Label
VIRT-NATE 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide, and cupric oxide tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69543-264
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE3000 [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-22 [iU]
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.8 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION28 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION25 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69543-264-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement08/19/201508/19/2015
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
size (solid drugs)19 mm
shape
scoring1
imprint
Labeler - Virtus Pharmaceuticals (079659493)

Revised: 11/2018
 
Virtus Pharmaceuticals