VP-PNV-DHA- vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide, cupric sulfate, doconexent, and icosapent capsule, liquid filled

VP-PNV-DHA by

Drug Labeling and Warnings

VP-PNV-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 Capsule
	Amount per Serving	% Daily Value for Pregnant and Lactating Women
* Daily Value not established
Vitamin A (Palmitate)	2500 IU	31%
Vitamin C (Ascorbic Acid)	80 mg	133%
Vitamin D (Vitamin D3 as Cholecalciferol)	400 IU	100%
Vitamin E (d-alpha Tocopherol)	30 IU	100%
Thiamine Mononitrate (Vitamin B1)	6 mg	353%
Riboflavin (Vitamin B2)	2.2 mg	110%
Niacin	20 mg	100%
Vitamin B6 (Pyridoxine HCl)	16 mg	640%
Folic Acid	1 mg	125%
Cyanocobalamin (Vitamin B12)	12 mcg	150%
Calcium (Calcium Carbonate)	50 mg	4%
Iron (Ferrous Fumarate)	28 mg	156%
Magnesium (Magnesium Oxide)	30 mg	7%
Zinc (Zinc Oxide)	20 mg	133%
Copper (Cupric Sulfate)	1 mg	50%
DHA and EPA (EPA 15.8 mg and DHA 200 mg)	215.8 mg	*

Other Ingredients: Gelatin, Glycerin, Purified Water, Beeswax, Soybean Oil, Soy Lecithin, FD&C Blue #2 Lake, Titanium Dioxide, Ethyl Vanillin.

DESCRIPTION

VP-PNV-DHA is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements and should be administered under the supervision of a licensed medical practitioner.

DOSAGE AND ADMINISTRATION

1 softgel capsule daily, 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.

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.

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

VP-PNV-DHA is supplied as oval, dark blue softgel capsule imprinted with "V223" dispensed in boxes of 30 capsules (10 × 3 blister packs).

SAFE HANDLING WARNING

Store at controlled room temperature 20°-25°C (68°-77°F). [See USP]. Protect from light and moisture. Notice: Contact with moisture may produce surface discoloration or erosion.

HEALTH CLAIM

Contains Fish Oil and Soy.

HEALTH CLAIM

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

Made in Canada

Rev. 03/2015

PRINCIPAL DISPLAY PANEL - 30 Softgel Blister Pack Carton

VIRTUS
PHARMACEUTICALS

69543-223-30

VP-PNV-DHA
PRENATAL/POSTNATAL

Multi-Vitamin/Mineral and
Omega-3 Fatty Acid Supplement

Gluten Free

Rx
30 Softgels
(10 x 3 Blister Packs)

INGREDIENTS AND APPEARANCE

VP-PNV-DHA 
vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide, cupric sulfate, doconexent, and icosapent capsule, liquid filled

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:69543-223
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91)	Vitamin A	2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	80 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	400 [iU]
.Alpha.-Tocopherol, D- (UNII: N9PR3490H9) (.Alpha.-Tocopherol, D- - UNII:N9PR3490H9)	.Alpha.-Tocopherol, D-	30 [iU]
Thiamine (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	6 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	2.2 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A)	Niacin	20 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine	16 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	12 ug
Calcium Carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	50 mg
Ferrous Fumarate (UNII: R5L488RY0Q) (Ferrous Cation - UNII:GW89581OWR)	Ferrous Cation	28 mg
Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838)	Magnesium Cation	30 mg
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 mg
Cupric Sulfate (UNII: LRX7AJ16DT) (Cupric Cation - UNII:8CBV67279L)	Cupric Cation	1 mg
Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC)	Doconexent	200 mg
Icosapent (UNII: AAN7QOV9EA) (Icosapent - UNII:AAN7QOV9EA)	Icosapent	15.8 mg

Inactive Ingredients
Ingredient Name	Strength
Gelatin (UNII: 2G86QN327L)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Yellow Wax (UNII: 2ZA36H0S2V)
Soybean Oil (UNII: 241ATL177A)
Lecithin, Soybean (UNII: 1DI56QDM62)
FD&C Blue No. 2 (UNII: L06K8R7DQK)
Aluminum Oxide (UNII: LMI26O6933)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ethyl Vanillin (UNII: YC9ST449YJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69543-223-30	3 in 1 CARTON
1		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		08/25/2015

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	23 mm
imprint

Labeler - Virtus Pharmaceuticals (079659493)