VP-VITE RX- ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, and calcium pantothenate tablet 
Virtus Pharmaceuticals

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VP-Vite Rx

69543-356-10

Rx

Prescription Folic Acid-Containing Dietary Supplement

DESCRIPTION

VP-Vite Rx is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving% Daily Value
Vitamin C
(ascorbic acid)
60 mg100%
Vitamin B1
(thiamine mononitrate)
1.5 mg100%
Vitamin B2
(riboflavin)
1.7 mg100%
Niacinamide
(vitamin B3)
20 mg100%
Vitamin B6
(pyridoxine HCl)
10 mg500%
Folic Acid1 mg250%
Vitamin B12
(cyanocobalamin)
6 mcg100%
Biotin300 mcg100%
Pantothenic Acid
(calcium pantothenate)
10 mg100%

Other Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Stearic Acid, Magnesium Stearate, Croscarmellose Sodium, Silica, Hypromellose, Titanium Dioxide, and FD&C Yellow #5.

Contains FD&C Yellow #5

INDICATIONS AND USAGE

VP-Vite Rx is indicated for the supplemental requirements of persons with nutritional deficiencies or those who are in need of nutritional supplementation.

CONTRAINDICATIONS

This product is contraindicated in persons with a known hypersensitivity to any of the ingredients.

PRECAUTIONS

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).

PATIENT INFORMATION

VP-Vite Rx is a prescription vitamin for use only under the direction and supervision of a licensed physician.

DRUG INTERACTIONS

Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

Drugs which may interact with folate include:

SIDE EFFECTS

Allergic sensitization has been reported following oral administration of folic acid. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

DIRECTIONS FOR USE

1 tablet daily with or without food or as prescribed by a licensed medical practitioner.

HOW SUPPLIED

VP-Vite Rx Supplied as round, yellow tablet imprinted with "V356" dispensed in 100 count bottles.

69543-356-10

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.

Call your licensed 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.

KEEP OUT OF REACH OF CHILDREN

Rx

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

Rev. 06/15

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

69543-356-10

VP-Vite Rx

Prescription Folic Acid-Containing
Dietary Supplement

Rx
100 Tablets

Made in the USA

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
VP-VITE RX 
ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, and calcium pantothenate tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69543-356
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 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) Pyridoxine10 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) Biotin300 ug
Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737, Calcium Cation - UNII:2M83C4R6ZB) Pantothenic Acid10 mg
Inactive Ingredients
Ingredient NameStrength
Calcium Phosphate, Dibasic, Anhydrous (UNII: L11K75P92J)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Magnesium Stearate (UNII: 70097M6I30)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Hypromelloses (UNII: 3NXW29V3WO)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69543-356-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT09/08/2015
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)10 mm
imprint
Labeler - Virtus Pharmaceuticals (079659493)

Revised: 9/2015
Document Id: 5d0810d2-9aa0-4850-ae6b-96a8b53bf2fe
Set id: fb8eb411-0bf2-4ba8-ae9a-b08f113d54d7
Version: 1
Effective Time: 20150917
 
Virtus Pharmaceuticals