Virt-Nate DHA

Manufacturer
Virtus Pharmaceuticals
Effective date
2016-01-21
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:12

Label at a glance#

ProductVirt-Nate DHA
Active ingredientASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, FERROUS FUMARATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC SULFATE, OMEGA-3 FATTY ACIDS
Label structure13 sections

Dosage and administration

Before, during, and/or after pregnancy regardless of lactation status, one softgel daily or as directed by a licensed healthcare practitioner. Supplement Facts Serving Size: 1 Softgel Amount Per Serving % Daily Value for Pregnant & Lactating Women Vitamin C (as ascorbic acid) 100 mg 167% Vitamin D (Vitamin D 3 as cholecalciferol) 400 IU 100% Vitamin E (as d-alpha tocopherol) 30 IU 100% Thiamin (as thiamine mononit...

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Prenatal/Postnatal Prescription Dietary Supplement

69543-370-30

Rx

DESCRIPTION

HEALTH CLAIM SECTION

Virt-Nate DHA is an orally administered prenatal/postnatal prescription dietary supplement with DHA and should be administered under the supervision of a licensed medical practitioner.

DIRECTIONS FOR USE

DOSAGE & ADMINISTRATION SECTION

Before, during, and/or after pregnancy regardless of lactation status, one softgel daily or as directed by a licensed healthcare practitioner.

Supplement Facts
Serving Size: 1 Softgel
Amount Per Serving% Daily Value for Pregnant & Lactating Women
Vitamin C (as ascorbic acid)100 mg167%
Vitamin D (Vitamin D3 as cholecalciferol)400 IU100%
Vitamin E (as d-alpha tocopherol)30 IU100%
Thiamin (as thiamine mononitrate)3 mg176%
Riboflavin3 mg150%
Vitamin B6 (as pyridoxine HCl)20 mg800%
Folic Acid1 mg125%
Vitamin B12 (as cyanocobalamin)15 mcg188%
Iron (as ferrous fumarate)28 mg156%
Magnesium (as magnesium oxide)30 mg7%
Zinc (as zinc oxide)20 mg133%
Copper (as cupric sulfate)1 mg50%
Omega-3 Fatty Acids (DHA-EPA)200 mg*

* Daily Value not established

Other Ingredients: Gelatin, Glycerin, Soybean Oil, Beeswax, Purified Water, Soy Lecithin, Natural Creamy Orange Flavor, Annatto Powder, Titanium Dioxide, and Ethyl Vanillin. Contains Fish Oil and Soy.

KEEP THIS OUT OF REACH OF CHILDREN

CONTRAINDICATIONS

HEALTH CLAIM SECTION

Virt-Nate DHA should not be used by patients with known history of hypersensitivity to any of its ingredients.

WARNINGS SECTION

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.

CAUTIONS

PRECAUTIONS SECTION

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).

Concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin or other anticonvulsants.

Exercise caution with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.

The action of levodopa is antagonized by pyridoxine.

Products containing iron should not be used during dimercaprol therapy. Dimercaprol can bind to iron and cause kidney damage.

Avoid administering omega-3 fatty acids to patients with inherited or acquired predisposition toward bleeding, including patients taking anticoagulants. Exercise caution with these patients to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

SIDE EFFECTS

HEALTH CLAIM SECTION

Allergic sensitization has been reported following oral administration of folic acid.

Iron can cause mild gastrointestinal side effects, particularly when taken on an empty stomach.

DRUG INTERACTIONS

HEALTH CLAIM SECTION

Folic Acid

HEALTH CLAIM SECTION

Concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur.

Folinic acid may enhance the toxicity of fluorouracil.

High levels of folic acid may result in decreased serum levels of pyrimethamine.

Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the hematopoietic response to folate.

Antiepileptic drugs (including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine) have been shown to impair folate absorption and increase the metabolism of circulating folate.

Fluoxetine

HEALTH CLAIM SECTION

Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport system in the intestine.

Decreased folic acid levels have been reported to be associated with the administration of Cholestyramine, Colestipol, Cycloserine, Dihydrofolate Reductase Inhibitors (aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim), L-dopa, colchicine, oral contraceptives, methylprednisolone, pancreatic extracts (pancreatin, pancrelipase), prolonged intravenous pentamidine, smoking and alcohol consumption, sulfasalazine, metformin, heme iron, isotretinoin, and after a 6-month course of therapy, warfarin can produce a significant impairment of folate status.

Thiamin (Vitamin B1)

HEALTH CLAIM SECTION

Furosemide, a loop diuretic, can decrease thiamin levels.

There have been case reports that fluorouracil may increase thiamin metabolism.

Vitamin B6

HEALTH CLAIM SECTION

Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by Vitamin B6. However, Vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

Isoniazid can produce a Vitamin B6 deficiency.

Vitamin B12

HEALTH CLAIM SECTION

Antibiotics, cholestyramine, colchicine, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12, and nitrous oxide can produce a functional vitamin B12 deficiency.

Vitamin D3

HEALTH CLAIM SECTION

Some thiazide diuretics, such as hydrochlorothiazide, as well as antacids, bile acid sequestrants (such as cholestyramine), mineral oil, orlistat, olestra, cimetidine, and anticonvulsant medications may reduce the absorption or increase the catabolism of Vitamin D.

Vitamin D supplementation should not be given with calcium to patients with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism or those who form calcium-containing kidney stones.

Iron

HEALTH CLAIM SECTION

Iron supplements might reduce the amounts of levodopa available to the body and diminish its clinical effectiveness.

Levothyroxine ingested simultaneously with iron can result in clinically significant reductions in levothyroxine efficacy.

Proton pump inhibitors reduce the acidity of stomach contents and can reduce iron absorption.

Zinc

HEALTH CLAIM SECTION

Zinc may decrease absorption of quinolone or tetracycline antibiotics.

Cupric oxide

HEALTH CLAIM SECTION

Concomitant use of penicillamine and copper can cause decreased absorption of both substances.

Omega-3 Fatty Acids

HEALTH CLAIM SECTION

Ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) may have potential antithrombotic effects, and may increase bleeding times.

Avoid administering omega-3 fatty acids to patients with inherited or acquired predisposition toward bleeding, including patients taking anticoagulants. Exercise caution with these patients to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

PREGNANT AND NURSING MOTHERS

HEALTH CLAIM SECTION

Virt-Nate DHA is a prescription folate dietary supplement formulated for use before, during and/or after pregnancy regardless of lactation status.

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

HEALTH CLAIM

HEALTH CLAIM SECTION

Adequate folate in healthful diets may reduce a woman's risk of having a child with a brain or spinal cord defect.

HOW SUPPLIED

HEALTH CLAIM SECTION

Virt-Nate DHA is supplied as annatto colored softgel, imprinted with "V370," dispensed in bottles of 30 softgels.

STORAGE

HEALTH CLAIM SECTION

Store at controlled room temperature 15° to 30°C (59° to 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.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

Rx

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

Made in Canada
Rev. 12/2015

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VIRTUS
PHARMACEUTICALS

69543-370-30

Virt-Nate DHA

PRENATAL/POSTNATAL

Prescription Dietary Supplement
with DHA

Rx
30 Softgels

Made in Canada

Principal Display Panel - 30 Softgel Bottle Label
Principal Display Panel - 30 Softgel Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
OMEGA-3 FATTY ACIDS Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69543-370-30Virt-Nate DHA30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69543-370VIRT-NATE DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, FERROUS FUMARATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC SULFATE, AND OMEGA-3 FATTY ACIDS) CAPSULE [VIRTUS PHARMACEUTICALS]11 package rows20160123_e554e0db-5f15-46d4-be02-dba3ba845063.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-370-30EA - Each69543-370ca1cf7d2-e5f7-493f-889e-8ec19e696b2812016-02-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69543-37069543-370-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
AscorASCORBIC ACIDMcGuff Pharmaceuticals, Inc.388aad52-fc01-4784-9791-1dbc80c693062026-05-29Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Skin Renewing SerumASCORBIC ACIDGuangzhou Danting Bath&Body Care Industry Co. Ltd396c2a8d-ac95-cbef-e063-6294a90aff392025-08-23WarningsName fallback
generic name: ASCORBIC ACID

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.