VIRTPREX- ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, tribasic calcium phosphate, ferrous fumarate, doconexent and docusate sodi  capsule, gelatin coated 
Virtus Pharmaceuticals LLC

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VirtPrex

DESCRIPTION

VirtPrex is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

Supplement Facts
Serving Size: 1 Capsule
Amount Per Serving% Daily Value for Pregnant & Lactating Women
*
From approximately 350 mg of Omega-3s derived from approximately 380 mg of purified fish oil.
Daily Value not established
Vitamin C (ascorbic acid)28 mg47%
Vitamin D (Vitamin D3 as cholecalciferol)400 IU100%
Vitamin E (d-alpha tocopherol)30 IU100%
Vitamin B6 (pyridoxine hydrochloride)25 mg1000%
Folic Acid1.2 mg150%
Calcium (tribasic calcium phosphate)160 mg12%
Iron (ferrous fumarate)26 mg144%
DHA (Docosahexaenoic Acid)300 mg*
Docusate Sodium55 mg

Other Ingredients: Maroon color shell (Gelatin, Glycerin, Purified Water, Titanium Dioxide, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, Ethyl Vanillin), Soy Lecithin, Yellow Bees Wax, Soybean Oil, Citric Acid, Natural Creamy Orange Flavour.

Contains FD&C Red #40, FD&C Yellow #6 and FD&C Blue #1, fish and soy.

DIRECTIONS FOR USE

1 softgel capsule daily with or without food or as prescribed by a licensed medical 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.

STORAGE

Store at room temperature 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.

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, maroon softgel capsule imprinted with "V348" dispensed in 30 count bottles.

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

Rev. 08/2015

PRINCIPAL DISPLAY PANEL - 30 Softgel Capsule Bottle Label

VIRTUS
PHARMACEUTICALS OPCO II

76439-348-30

VirtPrex

PRENATAL/POSTNATAL

Prescription Supplement Containing
Folic Acid and DHA

Rx

30 Softgel Capsules
Made in Canada

Principal Display Panel - 30 Softgel Capsule Bottle Label
VIRTPREX 
ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, tribasic calcium phosphate, ferrous fumarate, doconexent and docusate sodi capsule, gelatin coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-348
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) CHOLECALCIFEROL400 [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 ACID1.2 mg
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION160 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION26 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT300 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM55 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SOYBEAN OIL (UNII: 241ATL177A)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-348-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT08/12/201305/30/2017
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
flavor
scoring1
shape
size (solid drugs)19 mm
imprint
Labeler - Virtus Pharmaceuticals LLC (969483143)

Revised: 10/2017
 
Virtus Pharmaceuticals LLC