Label: VIRT-CAPS- ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, and calcium pantothenate capsule
- NHRIC Code(s): 69543-260-10
- Packager: Virtus Pharmaceuticals
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated August 24, 2015
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- HEALTH CLAIM
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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 SoftgelAmount 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.
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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.
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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
- CAUTION
- PREGNANCY and NURSING MOTHERS
- DIRECTIONS FOR USE
- STORAGE
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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
1-888-848-3593MADE IN USA
Rev. 06/2015
- PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label
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INGREDIENTS AND APPEARANCE
VIRT-CAPS
ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, and calcium pantothenate capsuleProduct 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)
