Extra-Virt Plus DHA

EXTRA-VIRT PLUS DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, biotin, calcium carbonate, docusate calcium, ferrous fumarate and doconexent capsule, gelatin coated
Virtus Pharmaceuticals LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx

DESCRIPTION: Extra-Virt Plus DHA is an orally administered prescription prenatal/postnatal multivitamin/ mineral softgel with fish-based DHA. Extra-Virt Plus DHA is available as opaque brown, oblong softgels imprinted “V251″ and are available in 30-count bottles (NDC 76439-251-30).

*
158 mg calcium from calcium carbonate and 2 mg calcium from docusate calcium.
Providing 350 mg DHA (docosahexaenoic acid)
Each softgel contains:
Vitamin C (ascorbic acid) 28 mg
Vitamin D3 (cholecalciferol) 800 IU
Vitamin E (d-alpha tocopherol) 30 IU
(Vitamin B6 ) (pyridoxine hydrochloride) 25 mg
Folic Acid 1.25 mg
Biotin 250 mcg
Calcium 160 mg *
Iron (ferrous fumarate) 29 mg
Omega oil blend 660 mg
Docusate Calcium 55 mg

Other Ingredients: Annatto, Beeswax, Citric Acid, Ethyl Vanillin, Gelatin, Glycerin, Natural Creamy Orange Flavor, Purified Water, Soy Lecithin, Titanium Dioxide.

This product contains soy and fish oil, derived from Scombridae fish, from purified fish oil containing less than one percent EPA.

INDICATIONS: Extra-Virt Plus DHA Softgels are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Extra-Virt Plus DHA Softgels may be useful in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS: Extra-Virt Plus DHA Softgels are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a healthcare practitioner.

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.

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

PRECAUTION: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a licensed healthcare practitioner.

HOW SUPPLIED: Extra-Virt Plus DHA is available as opaque brown, oblong softgels imprinted “V251″ and are available in 30-count bottles (NDC 76439-251-30).

KEEP OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Call your medical practitioner about side effects. You may also report side effects to Virtus Pharmaceuticals, LLC at 813-283-1344.

Store at 20 – 25°C (68 – 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light resistant container. Protect from light and moisture.

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619

Made in Canada

Rev. 03/13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VIRTUS PHARMACEUTICALS

NDC 76439-251- 30

Extra-Virt Plus DHA

Softgels

Rx

30 Softgels

PRINCIPAL DISPLAY PANEL -- 100 tablets
(click image for full-size original)
EXTRA-VIRT PLUS DHA
ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, biotin, calcium carbonate, docusate calcium, ferrous fumarate and doconexent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76439-251
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 28 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 800 [iU]
.ALPHA.-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 30 [iU]
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1.25 mg
BIOTIN (BIOTIN) BIOTIN 250 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 158 mg
DOCUSATE CALCIUM (DOCUSATE) DOCUSATE CALCIUM 55 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 29 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 350 mg
Inactive Ingredients
Ingredient Name Strength
ANNATTO
YELLOW WAX
CITRIC ACID MONOHYDRATE
ETHYL VANILLIN
GELATIN
GLYCERIN
WATER
LECITHIN, SOYBEAN
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (opaque brown) Score no score
Shape CAPSULE Size 25mm
Flavor ORANGE (natural creamy orange) Imprint Code V251
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76439-251-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/28/2012
Labeler — Virtus Pharmaceuticals LLC (969483143)
Establishment
Name Address ID/FEI Operations
Viva Pharmaceutical Inc. 253288898 MANUFACTURE (76439-251)

Revised: 03/2015 Virtus Pharmaceuticals LLC

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