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Virt-PN DHA Softgels

Generic Name: prenatal/postnatal multivitamin/mineral softgel with an essential fatty acid
Dosage Form: capsule, gelatin coated

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.

Virt-PN DHA
Softgels

Rx

Virt-PN DHA Softgels Description

Virt-PN DHA is a prescription prenatal/postnatal multivitamin/mineral softgel with an essential fatty acid. Virt-PN DHA are oblong, annattocolored soft gelatin capsules imprinted with "340".

Each capsule has the following active ingredient:
Folate 1 mg
(L-Methylfolate-calcium, or 6(S)-5-MTHF-Ca 600 mcg) (folic acid, USP 400 mcg)
Each capsule also contains the following ingredients for nutritional supplementation:
*
from at least 330 mg purified fish oil.
Vitamin C (ascorbic acid) 85 mg
Vitamin D3 (cholecalciferol) 200 IU
Vitamin E (d-alpha tocopherol) 10 IU
Vitamin B6 (pyridoxine HCI) 25 mg
Vitamin B12 (cyanocobalamin) 12 mcg
Calcium (calcium carbonate) 140 mg
Iron (ferrous fumarate) 27 mg
Magnesium (magnesium oxide) 45 mg
Docosahexaenoic Acid (DHA) 300 mg*

Inactive Ingredients

Annatto (color), Citric Acid, Ethyl Vanillin, Gelatin, Glycerin, Lecithin, Natural Creamy Orange Flavor, Purified Water, Soybean Oil, TriPotassium Citrate, and Yellow Bees Wax.

Indications and Usage for Virt-PN DHA Softgels

Virt-PN DHA is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.

Warning

Daily ingestion of more than 3 g per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils 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 diatheses, including those taking anticoagulants.

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.

This product contains soybean oil and fish oil.

CAUTION

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

Precautions

General

Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of vitamin B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of vitamin B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of vitamin B12 deficiency.

PATIENT INFORMATION

Virt-PN DHA is a prescription vitamin for use only under the direction and supervision of a licensed physician.

INTERACTIONS

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

Drugs which may interact with folate include:

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

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

  • Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
  • Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
  • Colestipol: Reduces folic acid absorption and reduces serum folate levels.
  • Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
  • Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
  • Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
  • Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
  • Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
  • Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
  • Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts.
  • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
  • Smoking and Alcohol: Reduced serum folate levels have been noted.
  • Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
  • Metformin treatment in patients with type 2 diabetes decreases serum folate.
  • Warfarin can produce significant impairment in folate status after a 6-month therapy.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates - including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

Virt-PN DHA Softgels Dosage and Administration

Before, during, and/or after pregnancy, one softgel daily or as prescribed by a physician.

How is Virt-PN DHA Softgels Supplied

Dispensed in bottles of 30 softgels.
Product Code 76439-340-30

STORAGE

Store at controlled room temperature 20°-25°C (68°-77°F).
Excursions permitted to 15° to 30°C (59° to 86°F). [See USP].

Call your medical practitioner about side effects.
You may report side effects by calling 813-283-1344.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx

All prescriptions using this product shall be pursuant to state statutes
as applicable. This is not an Orange Book product. There are no
implied or explicit claims on therapeutic equivalence.

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619

Rev. 06/12

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

VIRTUS
PHARMACEUTICALS

Product Code: 76439-340-30

Virt-PN
DHA Softgels

Rx

30 Softgels

VIRT-PN DHA 
levomefolate calcium, pyridoxine, calcium carbonate, sodium ascorbate, cholecalciferol, .alpha.-tocopherol, d-, cyanocobalamin, ferrous fumarate, magnesium oxide, and doconexent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-340
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE CALCIUM 1 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 25 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 140 mg
SODIUM ASCORBATE (ASCORBIC ACID) SODIUM ASCORBATE 85 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 200 [iU]
.ALPHA.-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 10 [iU]
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
FERROUS FUMARATE (FERROUS CATION) FERROUS FUMARATE 27 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 45 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg
Inactive Ingredients
Ingredient Name Strength
Annatto  
Ethyl Vanillin  
Gelatin  
Glycerin  
Citric Acid Monohydrate  
Egg Phospholipids  
Citrus Sinensis Fruit Oil  
Water  
Soybean Oil  
Yellow Wax  
Potassium Citrate Anhydrous  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 25mm
Flavor Imprint Code 340
Contains         
Packaging
# Item Code Package Description
1 NDC:76439-340-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 07/12/2012
Labeler - Virtus Pharmaceuticals (969483143)
Revised: 10/2012
 
Virtus Pharmaceuticals
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