VIRT-CAPS- ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, and calcium pantothenate capsule 
Virtus Pharmaceuticals

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Virt-Caps

69543-260-10

Rx

Prescription Dietary Supplement

DESCRIPTION

Virt-Caps is an orally administered prescription vitamin B dietary supplement formulated for the dietary management of persons who require increased amounts of folic acid and pyridoxine; it also includes vitamin C. Virt-Caps should be administered under the supervision of a licensed medical practitioner.

Supplement Facts
Serving Size: 1 Softgel
Amount Per Serving% Daily Value
Vitamin C (as ascorbic acid)100 mg167%
Thiamine (as thiamine mononitrate)1.5 mg100%
Riboflavin1.7 mg100%
Niacin (as niacinamide)20 mg100%
Vitamin B6 (as pyridoxine HCl)10 mg500%
Folic Acid1 mg250%
Vitamin B12 (as cyanocobalamin)6 mcg100%
Biotin150 mcg50%
Pantothenic Acid (as calcium pantothenate)5 mg50%

Other Ingredients: Soybean Oil, Gelatin, Glycerin, Water, Bees Wax, Lecithin, Titanium Dioxide, FD&C Yellow #6, FD&C Red #40, and FD&C Blue #1.

Contains Soy, FD&C Yellow #6, FD&C Red #40 and FD&C Blue #1.

Side Effects

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

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.

KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.

INTERACTIONS

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

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

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

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

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

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of its components.

CAUTION

High levels of folic acid may, especially in older adults, hide signs of vitamin B12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

PREGNANCY and NURSING MOTHERS

This product contains only B and C vitamins and is not intended for use as a prenatal/postnatal multivitamin.

DIRECTIONS FOR USE

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

STORAGE

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

HOW SUPPLIED

Virt-Caps is supplied as black softgels imprinted on one side with "V260" dispensed in child-resistant bottles of 100 softgels

69543-260-10

KEEP THIS OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Call your medical practitioner about side effects. You may report side effects by calling Virtus at 1-888-848-3593 or FDA at 1-800-FDA-1088.

Rx

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

MADE IN USA

Rev. 06/2015

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

VIRTUS
PHARMACEUTICALS

69543-260-10

Virt-Caps

Prescription Dietary Supplement

Rx
100 Softgels
Made in USA

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label
VIRT-CAPS 
ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, and calcium pantothenate capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69543-260
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN150 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB) PANTOTHENIC ACID5 mg
Inactive Ingredients
Ingredient NameStrength
SOYBEAN OIL (UNII: 241ATL177A)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69543-260-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT08/14/2015
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)15 mm
imprint
Labeler - Virtus Pharmaceuticals (079659493)

Revised: 8/2015
Document Id: 2e8a71d5-ba35-40d0-9b3f-9206f7fac8bd
Set id: 93ecc6fb-bde7-44b0-be29-7df42b26d6a0
Version: 1
Effective Time: 20150824
 
Virtus Pharmaceuticals