VP-CH-PNV- cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, calcium citrate, iron pentacarbonyl, docusate sodium, doconexent, and icosapent capsule 
Virtus Pharmaceuticals

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VP-CH-PNV
PRENATAL/POSTNATAL

Supplement Facts
Serving Size: 1 Softgel
Amount Per Serving% Daily Value for Pregnant and Lactating Women
*
Daily Value not established
Contains less than 1% Eicosapentaenoic Acid (EPA)
Vitamin D (Vitamin D3 as cholecalciferol)400 IU100%
Vitamin E (dl-alpha tocopherol acetate)30 IU100%
Vitamin B6 (pyridoxine HCl)25 mg1000%
Folic Acid1 mg125%
Calcium (citrate)104 mg8%
Iron (carbonyl)30 mg167%
Docusate Sodium50 mg*
Docosahexaenoic Acid (DHA)260 mg*

Other Ingredients: Gelatin, Glycerin, Soybean Oil, Soy Lecithin, Ethyl Vanillin, Purified Water, Yellow Beeswax, Natural Creamy Orange Flavor, Carmine Hydrosoluble, Ethyl Vanillin, Titanium Dioxide, FD&C Red #40, FD&C Blue #1.

Contains Carmine, Fish (tuna), Soy, FD&C Blue #1, and FD&C Red #40.

DESCRIPTION

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

DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one softgel daily or as directed by a licensed healthcare practitioner regardless of lactation status.

CAUTION

Ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

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.

CAUTION

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.

Store at 15° – 30°C (59° – 86°F). [See USP Controlled Room Temperature.] 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.

HOW SUPPLIED

Supplied as oblong, purple softgel imprinted "V224" dispensed in bottles of 30 softgels.

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

Rev. 03/15

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

VIRTUS
PHARMACEUTICALS

69543-224-30

VP-CH-PNV

PRENATAL/POSTNATAL

Prescription Folic Acid-Containing
Dietary Supplement

Rx
30 Softgels

Principal Display Panel - 30 Softgel Bottle Label
VP-CH-PNV 
cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, calcium citrate, iron pentacarbonyl, docusate sodium, doconexent, and icosapent capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69543-224
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS104 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION30 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT260 mg
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT2.6 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
Soybean Oil (UNII: 241ATL177A)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Ethyl Vanillin (UNII: YC9ST449YJ)  
Water (UNII: 059QF0KO0R)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69543-224-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT09/08/201502/09/2017
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)17 mm
imprint
flavor
Labeler - Virtus Pharmaceuticals (079659493)

Revised: 11/2017
 
Virtus Pharmaceuticals