PNV-VP-U- sodium ascorbate, thiamine mononitrate, riboflavin, niacinamide, folic acid, cyanocobalamin, calcium pantothenate, ferrous fumarate, cupric sulfate and manganese sulfate  capsule 
Virtus Pharmaceuticals LLC

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PNV-VP-U

STATEMENT OF IDENTITY: PNV-VP-U 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: 1 capsule daily, in between meals, orally. Do not exceed recommended dosage. Do not administer to children.

Vitamin C (sodium ascorbate) 200 mg
Vitamin B1 (thiamine mononitrate) 10 mg
Vitamin B2 (riboflavin)6 mg
Niacin (niacinimide) 30 mg
Vitamin B6 (pyridoxine HCl) 5 mg
Folic Acid1 mg
Vitamin B12 (cyanocobalamin) 15 mcg
Pantothenic Acid (calcium pantothenate) 10 mg
Iron (ferrous fumarate) 106.5 mg
Copper (cupric sulfate) 0.8 mg
Manganese (manganese sulfate) 1.3 mg

Other Ingredients: Gelatin, Microcrystalline Cellulose (Kosher [KO]), Magnesium Stearate (Kosher [KO]), Silicon Dioxide (Kosher [KO]), Titanium Dioxide, FD&C Blue #1, FD&C Red #3.

How Supplied: Supplied as a purple capsule imprinted with "V265" dispensed in boxes of 100 capsules (10 x 10 blister packs).

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 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Notice: Contact with moisture may produce surface discoloration or erosion.

HEALTH CLAIMS: Prescription Vitamin B and Iron Containing Dietary Supplement

PRINCIPAL DISPLAY PANEL - 100 capsules blister pack

VIRTUS
PHARMACEUTICALS

NDC 76439-265-10

PNV-VP-U

PRENATAL/POSTNATAL

Prescription Vitamin B9-Containing
Dietary Supplement

SAFETY SEALED:
DO NOT USE IF BLISTER SEAL IS BROKEN

Rx
100 Capsules
(10 x 10 Blister Packs)

Made in the USA

PRINCIPAL DISPLAY PANEL - 100 capsules blister pack
PNV-VP-U 
sodium ascorbate, thiamine mononitrate, riboflavin, niacinamide, folic acid, cyanocobalamin, calcium pantothenate, ferrous fumarate, cupric sulfate and manganese sulfate capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-265
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) SODIUM ASCORBATE200 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE10 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN6 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE30 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN15 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION106.5 mg
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION0.8 mg
MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+)1.3 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin, Unspecified (UNII: 2G86QN327L)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-265-10100 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT07/29/201308/02/2014
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
Document Id: 7cc74395-c857-48cf-8ee1-72fb7815adf4
Set id: e40a6268-7651-4a08-a986-0dbca1df179b
Version: 2
Effective Time: 20171007
 
Virtus Pharmaceuticals LLC