VIRT-SELECT  PRENATAL/POSTNATAL- ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, calcium phosphate, ferrous fumarate, doconexent, and docusate sodium capsule, gelatin coated 
Virtus Pharmaceuticals

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Virt-Select
PRENATAL/POSTNATAL

Supplement Facts
Serving Size: 1 Softgel
Amount Per Serving%Daily Value for Pregnant and Lactating Women
*
Derived from at least 338.1 mg omega-3s from at least 476.1 mg purified fish oil.
Daily Value not established
Vitamin C (ascorbic acid)28 mg47%
Vitamin D (Vitamin D3 as cholecalciferol)800 IU200%
Vitamin E (d-alpha-tocopherol)30 IU100%
Vitamin B6 (pyridoxine hydrochloride)25 mg1000%
Folic Acid, USP1.25 mg156%
Calcium (tribasic calcium phosphate)160 mg12%
Iron (ferrous fumarate)29 mg161%
DHA (docosahexaenoic acid, contained in the oil derived from fish)325 mg*
Docusate Sodium, USP55 mg

Other Ingredients: Annatto, Citric Acid, Ethyl Vanillin, Gelatin, Glycerin, Natural Creamy Orange Flavor, Purified Water, Soy Lecithin, Soybean Oil, Titanium Dioxide, Yellow Beeswax.

CONTAINS SOY AND FISH OIL.

DESCRIPTION

Virt-Select is a prescription prenatal/postnatal multivitamin/mineral dietary supplement with fish-based DHA 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

Daily 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 20° to 25°C (68° to 77°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 1-855-255-6076 or FDA at 1-800-FDA-1088.

HOW SUPPLIED

Supplied as oblong, annatto softgel imprinted "V249" dispensed in 30 count bottles.

Manufactured for:
Virtus Pharmaceuticals OPCO II, LLC
Nashville, TN 37217
1-855-255-6076

Made in Canada

Rev. 08/15

Lot:
Exp:

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

VIRTUS
PHARMACEUTICALS

76439-249-30

Virt-Select

PRENATAL/POSTNATAL

Prescription Multivitamin/Mineral
Dietary Supplement with Fish-Based DHA

Rx
30 Softgels

Principal Display Panel - 30 Softgel Bottle Label
VIRT-SELECT   PRENATAL/POSTNATAL
ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, calcium phosphate, ferrous fumarate, doconexent, and docusate sodium capsule, gelatin coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-249
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid28 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol800 [iU]
.Alpha.-Tocopherol, D- (UNII: N9PR3490H9) (.Alpha.-Tocopherol, D- - UNII:N9PR3490H9) .Alpha.-Tocopherol, D-30 [iU]
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride25 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1.25 mg
CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Cation160 mg
Ferrous Fumarate (UNII: R5L488RY0Q) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation29 mg
Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent325 mg
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium55 mg
Inactive Ingredients
Ingredient NameStrength
Annatto (UNII: 6PQP1V1B6O)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Ethyl Vanillin (UNII: YC9ST449YJ)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Soybean Oil (UNII: 241ATL177A)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-249-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT12/19/201401/13/2017
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)25 mm
imprint
flavor
Labeler - Virtus Pharmaceuticals (969483143)

Revised: 10/2017
 
Virtus Pharmaceuticals