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

Virt-PN DHA by

Drug Labeling and Warnings

Virt-PN DHA by is a Other medication manufactured, distributed, or labeled by Virtus Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

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 mg	142%
Vitamin D (Vitamin D3 as cholecalciferol)	200 IU	50%
Vitamin E (d-alpha tocopherol)	10 IU	33%
Vitamin B6 (pyridoxine HCl)	25 mg	1000%
Folate (L-Methylfolate calcium, or 6(S)-5-MTHF-Ca 600 mcg) (folic acid, USP 400 mcg)	1 mg	125%
Vitamin B12 (cyanocobalamin)	12 mcg	150%
Calcium (calcium carbonate)	140 mg	11%
Iron (ferrous fumarate)	27 mg	150%
Magnesium (magnesium oxide)	45 mg	10%
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.

WARNINGS

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.

SAFE HANDLING WARNING

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.

HEALTH CLAIM

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.

HEALTH CLAIM

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

INGREDIENTS AND APPEARANCE

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 Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:69543-340
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	85 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	200 [iU]
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	10 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	25 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	600 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	400 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	140 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	45 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	300 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69543-340-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		09/08/2015

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	25 mm
imprint

Labeler - Virtus Pharmaceuticals (079659493)