VIRT-PN DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, levomefolate calcium, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide, and doconexent capsule 
Virtus Pharmaceuticals

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Virt-PN DHA
PRENATAL/POSTNATAL

Supplement Facts
Serving Size: 1 Softgel
Amount Per Serving% Daily Value for Pregnant and Lactating Women
*
From at least 330 mg purified fish oil.
Daily Value not established
Vitamin C (ascorbic acid)85 mg142%
Vitamin D (Vitamin D3 as cholecalciferol)200 IU50%
Vitamin E (d-alpha tocopherol)10 IU33%
Vitamin B6 (pyridoxine HCl)25 mg1000%
Folate (L-Methylfolate calcium, or 6(S)-5-MTHF-Ca 600 mcg) (folic acid, USP 400 mcg)1 mg125%
Vitamin B12 (cyanocobalamin)12 mcg150%
Calcium (calcium carbonate) 140 mg11%
Iron (ferrous fumarate)27 mg150%
Magnesium (magnesium oxide)45 mg10%
Docosahexaenoic Acid (DHA)300 mg*

Other Ingredients: Soybean Oil, Gelatin, Glycerin, DI Water, Yellow Beeswax, Lecithin, Annatto Extract, Titanium Dioxide, FD&C Red #40, and FD&C Blue #1.

CAUTION: Contains Soy, Fish Oil, FD&C Red #40, and FD&C Blue #1.

DESCRIPTION

Virt-PN DHA 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

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). 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.

HOW SUPPLIED

Supplied as oblong, annatto-colored softgel, imprinted "340" and dispensed in 30 count bottles.

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

Rev. 12/2015

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

VIRTUS
PHARMACEUTICALS

69543-340-30

Virt-PN DHA

PRENATAL/POSTNATAL

Prescription Multivitamin/Mineral
Dietary Supplement with Fish-Based DHA

Rx

30 Softgels
Made in USA

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label
VIRT-PN DHA 
ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, levomefolate calcium, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide, and doconexent capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69543-340
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID85 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL200 [iU]
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-10 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID600 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID400 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION140 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION45 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT300 mg
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
SOYBEAN OIL (UNII: 241ATL177A)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ANNATTO (UNII: 6PQP1V1B6O)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69543-340-3030 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)25 mm
imprint
Labeler - Virtus Pharmaceuticals (079659493)

Revised: 3/2016
Document Id: 51bdd822-bda3-4a45-aecf-09f6170b6996
Set id: 6998a356-6a0d-4cc6-8719-a9b52c8799b6
Version: 2
Effective Time: 20160308
 
Virtus Pharmaceuticals