Virt-C DHA: Package Insert and Label Information

VIRT-C DHA- ascorbic acid, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, ferrous fumarate, iron, magnesium sulfate, unspecified form, zinc sulfate, unspecified form, cupric sulfate, doconexent and icosapent capsule, gelatin coated
Virtus Pharmaceuticals

DESCRIPTION

Virt-C DHA is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

Supplement Facts
Serving Size: 1 Softgel
	Amount Per Serving	% Daily Value for Pregnant & Lactating Women
* Also containing Ascorbic Acid Precursors as (1) Acid Metabolites including niacinamide ascorbate, calcium ascorbate, magnesium ascorbate, potassium ascorbate and sodium ascorbate; (2) Basic Amino Acids including lysine acetate; (3) Flavonoids including hesperidin; and (4) Glutathione. † Minimum Iron Salt content. ‡ Total Iron: Ferrous Fumarate + Polysaccharide Iron Complex. § At least 200 mg Omega-3 Fatty Acids derived from 310 mg fish oil. ¶ Daily Value not established.
Vitamin C *	25 mg	42%
Thiamine Mononitrate (B1 )	2 mg	118%
Riboflavin (B2 )	3 mg	150%
Niacin (B3 )*	1.8 mg	9%
Pyridoxine HCl (B6 )	25 mg	1000%
Folic Acid	1 mg	125%
Cyanocobalamin (B12 )	12.5 mcg	156%
Biotin (B7 )	300 mcg	100%
d-Calcium Pantothenate (B5 )	5 mg	50%
Ferrous Fumarate (anhydrous) (Equivalent to about 17.5 mg of Elemental iron)	53.5 mg †
Polysaccharide Iron Complex (Equivalent to about 17.5 mg of Elemental iron)	38 mg †	‡194%
Magnesium (as magnesium sulfate)	5 mg	1%
Zinc (as zinc sulfate)	10 mg	67%
Copper (as copper sulfate)	2 mg	100%
Omega-3 Fatty Acids §	200 mg	¶
Docosahexaenoic Acid (DHA)	156 mg	¶
Eicosapentaenoic Acid (EPA)	39 mg	¶

Other Ingredients: Lecithin, Beeswax, Soybean Oil, Caramel, Capsule (Gelatin, Glycerin, Water, and Caramel). Contains Soy and Fish Oil.

DOSAGE AND ADMINISTRATION

1 softgel daily, in between meals, 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 that can cause nerve damage.

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-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 1-888-848-3593 or FDA at 1-800-FDA-1088.

HOW SUPPLIED

Supplied as oblong, dark black color softgel imprinted with “V355” dispensed in 30 count bottles.

Manufactured for:
Virtus Pharmaceuticals, LLC
Langhorne, PA 19047
1-888-848-3593
Rev. 07/2019

PRINCIPAL DISPLAY PANEL — 30 Softgel Bottle Label

VIRTUS^®
PHARMACEUTICALS

76439-331- 30

Virt-C DHA

PRENATAL/POSTNATAL

Prescription Folic Acid-Containing
Dietary Supplement
with Omega-3 Fatty Acids

R_X

30 Softgels
Made in the USA

VIRT-C DHA ascorbic acid, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, ferrous fumarate, iron, magnesium sulfate, zinc sulfate, cupric sulfate, doconexent, and icosapent capsule, gelatin coated

Product Information Product Type Item Code (Source) NDC:76439-331 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 25 mg THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 2 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg NIACIN (NIACIN) NIACIN 1.8 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12.5 ug BIOTIN (BIOTIN) BIOTIN 300 ug CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 5 mg FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 53.5 mg IRON (IRON) IRON 38 mg MAGNESIUM SULFATE, UNSPECIFIED FORM (MAGNESIUM CATION) MAGNESIUM SULFATE, UNSPECIFIED FORM 5 mg ZINC SULFATE, UNSPECIFIED FORM (ZINC CATION) ZINC SULFATE, UNSPECIFIED FORM 10 mg CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 2 mg DOCONEXENT (DOCONEXENT) DOCONEXENT 156 mg ICOSAPENT (ICOSAPENT) ICOSAPENT 39 mg

Inactive Ingredients Ingredient Name Strength YELLOW WAX SOYBEAN OIL CARAMEL GELATIN, UNSPECIFIED GLYCERIN WATER

Product Characteristics Color BLACK Score no score Shape OVAL (oblong) Size 15mm Flavor Imprint Code V355 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76439-331-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Dietary Supplement 03/31/2015

Labeler — Virtus Pharmaceuticals (079659493)

Establishment
Name	Address	ID/FEI	Operations
Captek Pharma		015869178	MANUFACTURE

Revised: 11/2019 Virtus Pharmaceuticals