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

Virt-Caps by

Drug Labeling and Warnings

Virt-Caps by is a Other medication manufactured, distributed, or labeled by Virtus Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

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 mg	167%
Thiamine (as thiamine mononitrate)	1.5 mg	100%
Riboflavin	1.7 mg	100%
Niacin (as niacinamide)	20 mg	100%
Vitamin B6 (as pyridoxine HCl)	10 mg	500%
Folic Acid	1 mg	250%
Vitamin B12 (as cyanocobalamin)	6 mcg	100%
Biotin	150 mcg	50%
Pantothenic Acid (as calcium pantothenate)	5 mg	50%

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:

• 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
• 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
• Colchicine
• Levodopa
• Cycloserine
• Isotretinoin
• 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, colchicine, colestipol, metformin, para-aminosalicylic acid, and potassium chloride (may decrease the absorption of vitamin B12)
• Nitrous oxide (can produce a functional vitamin B12 deficiency)

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:69543-260
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.7 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	6 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	150 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB)	PANTOTHENIC ACID	5 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69543-260-10	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		08/14/2015

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	15 mm
imprint

Labeler - Virtus Pharmaceuticals (079659493)