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

----------

Virt-Advance

STATEMENT OF IDENTITY: Virt-Advance is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

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: Usual dosage is 1 tablet daily, or as prescribed by a licensed medical practitioner regardless of lactation status.

Vitamin A (beta carotene) 2700 IU
Vitamin C (ascorbic acid) 120 mg
Vitamin D3 (cholecalciferol)400 IU
Vitamin E (dl-alpha tocopheryl acetate) 30 IU
Vitamin B1 (thiamine mononitrate) 3 mg
Vitamin B2 riboflavin 3.4 mg
Niacin (niacinamide) 20 mg
Vitamin B6 (pyridoxine hydrochloride) 20 mg
Folic Acid 1 mg
Vitamin B12 (cyanocobalamin) 12 mcg
Calcium (calcium carbonate) 200 mg
Iron (carbonyl iron) 90 mg
Magnesium (magnesium oxide) 30 mg
Zinc (zinc oxide) 25 mg
Copper (cupric oxide) 2 mg
Docusate Sodium50 mg

Other Ingredients: Yellow Coating (Hydoxypropylmethyl Cellulose, Titanium Dioxide, Polyvinyl Alcohol, Polyethylene Glycol, Talc, FD&C Yellow #5 Lake, FD&C Yellow #6, FD&C Blue #2 Lake) Microcrystalline Cellulose,TriPotassium Citrate, Acacia, Fumed Silica, Croscarmellose Sodium, Citric Acid, Povidone, Magnesium Stearate, Stearic Acid.

How Supplied: Supplied as oval, yellow tablets debossed with "V357" dispensed in 90 count bottles.

PRECAUTIONS/WARNING: Folic Acid may obscure pernicious anemia in that the peripheral blood picture may revert to normal while neurological manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of Folic Acid.

STORAGE: Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

HEALTH CLAIMS: Prescription Vitamin B9 Containing Dietary Supplement

PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label

VIRTUS
PHARMACEUTICALS

76439-357-90

Virt-Advance

PRENATAL/POSTNATAL

Prescription Vitamin
B9-Containing
Dietary Supplement

Rx

90 Tablets         Made in the Canada

PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label
VIRT-ADVANCE 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide and docusate sodium tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-357
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-30 [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) PYRIDOXINE HYDROCHLORIDE20 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 CARBONATE200 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 CATION25 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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
ACACIA (UNII: 5C5403N26O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-357-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT08/15/201402/09/2017
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)19 mm
imprint
Labeler - Virtus Pharmaceuticals LLC (969483143)

Revised: 10/2017
 
Virtus Pharmaceuticals LLC