Skip to Content

Virt-BAL DHA Plus

Generic Name: prenatal/postnatal multivitamin/mineral
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-BAL DHA Plus

30 Tablets / 30 Softgels
Product Code: 76439-225-60
Rx
PRENATAL / POSTNATAL
Prescription Folate

Virt-BAL DHA Plus Description

Virt-BAL DHA Plus is an orally administered PRENATAL / POSTNATAL prescription folate specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.

Virt-BAL DHA Plus should be administered under the supervision of a licensed medical practitioner.

Each oval, yellow tablet contains the following dietary ingredients:

*
Folates are B vitamins necessary for methylation and DNA/RNA synthesis. Variant forms of vitamin B9 - such as folinic or folic acid, are necessary to reduce the risk of Neural Tube Defects (NTDs) during the first trimester of pregnancy.
  Vitamin A (beta carotene) 2850 IU
  Vitamin C (ascorbic acid) 120 mg
  Vitamin D3 (cholecalciferol) 840 IU
  Vitamin E (dl-alpha tocopherol acetate) 3 mg
  Vitamin B1 (thiamine mononitrate) 1.8 mg
  Vitamin B2 (riboflavin) 4 mg
  Vitamin B3 (niacinamide) 20 mg
  Vitamin B6 (pyridoxine HCl) 50 mg
  Folate* 1 mg
  Vitamin B12 (cyanocobalamin) 12 mcg
  Calcium (carbonate) 219 mg
  Iron (elemental)
    (polysaccharide iron complex, and sodium iron EDTA)
Approximately 26.49 mg
  Magnesium (oxide) 25 mg
  Zinc (oxide) 25 mg
  Copper (cupric oxide) 2 mg
  Iodine 220 mcg

Each oblong, light-yellow / semi-transparent enteric-coated soft gelatin capsule contains the following essential fatty acids - including DHA, EPA and DPA, and is derived from no less than approximately 656 mg of purified fish oil:

  Total omega-3 long chain fatty acids At least 374 mg
  As DHA (docosahexaenoic acid) Approximately 262 mg
  As other omega-3 long-chain fatty acids Approximately 112 mg

Other Ingredients (tablet):

 
Acacia, Citric Acid, Croscarmellose Sodium, Fumed Silica, Magnesium Stearate, Microcrystalline Cellulose, Polyvinylpyrrolidone, Stearic Acid, Tripotassium Citrate, Yellow Coating (FD&C Blue #1 Lake, FD&C Yellow #5 Lake, FD&C Yellow #6 Lake, Hydroxypropylmethyl Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide).

Other Ingredients (softgel):

 
Gelatin, Glycerin, Purified Water, Vitamin E Oil, Enteric Coating (Acetylated Monoglycerides, Shellac, Stearic Acid, Sodium Alginate, Polysorbate 80, Potassium Sorbate).
 
Gluten Free

Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.

This product contains fish (anchovy and sardine) and soy. This product also contains bovine gelatin.

This product contains FD&C Yellow #5 Lake (tartrazine) and FD&C Yellow #6 Lake.

FOLATE REGULATION

The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate.

Individuals with genetic polymorphorisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B12 dependent methylation cycle.

Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.

The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that:

Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.

Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).

1
It is not known whether or not l-methylfolate can obscure pernicious anemia above 0.1 mg doses, so caution is advised also with this form of folate.

Indications and Usage for Virt-BAL DHA Plus

Virt-BAL DHA Plus is indicated for the distinct nutritional requirements of patients in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner.

Virt-BAL DHA Plus is also indicated as supplementation therapy during pre/post pregnancy as well as while lactating / non-lactating.

Virt-BAL DHA Plus should be administered under the supervision of a licensed medical practitioner.

Contraindications

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

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.

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

Precautions

General

Folate, when administered as a single agent in doses about 0.1 mg daily, may obscure the detection of vitamin B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency.

This product contains FD&C Yellow No. 5 Lake (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. This product also contains FD&C Yellow No. 6 Lake.

CAUTION

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

PATIENT INFORMATION

Virt-BAL DHA Plus is a PRENATAL / POSTNATAL prescription folate to be used only under licensed medical supervision.

DRUG INTERACTIONS

Drugs which may interact with folate2 include:

  • Antiepileptic drugs (AED): The AED class 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.
  • Additionally, 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 and other anticonvulsants.
  • 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.
  • L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels.
  • 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, such as pancreatin and pancrelipase.
  • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
  • Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.
  • 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.
  • Heme-iron: Can compete for transport and reduce folate absorption. Ensure adequate medical supervision to ensure proper iron levels.
  • Folinic acid may enhance the toxicity of fluorouracil.
  • Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate.
  • Caution should be exercised 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.

Drugs which interact with vitamin B12:

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

Drugs which interact with vitamin B6:

  • 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.

Drugs which may interact with vitamin D3:

  • Certain 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 in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Drugs which may interact with zinc:

  • Concomitant administration of zinc supplements and certain antibiotics, specifically tetracyclines and quinolones, may decrease absorption of the antibiotic and potentially reduce its efficacy.
  • Iron may reduce zinc absorption.
2
Folate is a broad term that includes folic acid and all reduced forms including l-methylfolate and folinic acid. Virt-BAL DHA Plus does not contain l-methylfolate but these warnings are included as general folate information.

PREGNANCY and NURSING MOTHERS

Virt-BAL DHA Plus is intended for use as a prescription PRENATAL folate before, during, and after pregnancy regardless of lactation status.

Adverse Reactions

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnolence, nausea and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.

Virt-BAL DHA Plus Dosage and Administration

Before, during, and after pregnancy, one tablet and one softgel capsule, taken by mouth daily, or as directed by a licensed medical practitioner. Tablets and softgel capsules may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1000 mg) per day.

STORAGE

Store at Controlled Room Temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container. NOTICE: Contact with moisture can discolor or erode the tablet.

How is Virt-BAL DHA Plus Supplied

Virt-BAL DHA Plus is supplied as oval, yellow tablets debossed on one side with "V225" and oblong, light-yellow / semi-transparent enteric-coated soft gelatin capsules, dispensed in child-resistant blister packs of 30 tablets and 30 softgel capsules.

KEEP THIS 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 report side effects by calling (813) 283-1344.

Product Code: 76439-225-60

*This product is a PRENATAL/POSTNATAL prescription folate that contains folate in an amount higher than 0.1 mg, and has an increased risk associated with masking of vitamin B12 deficiency and must be administered under a physician's supervision (AUG 3 1973 FR 20750). This product requires licensed medical supervision and a Rx status as required by pedigree reporting requirements.

Rx

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619

MADE IN CANADA

VIRTUS
PHARMACEUTICALS

Rev. 6/2012

PRINCIPAL DISPLAY PANEL - 30 Tablet / 30 Softgel Kit Carton

VIRTUS
PHARMACEUTICALS

Product Code* 76439-225-60
Virt-BAL DHA Plus
PRENATAL / POSTNATAL

Prescription Folate

30 Tablets / 30 Softgels
Rx

Virt-BAL DHA Plus 
folic acid, pyridoxine, calcium carbonate, sodium ascorbate, cholecalciferol, acetate ion, thiamine mononitrate, riboflavin, niacinamide, cyanocobalamin, ferrous bisglycinate hydrochloride, iodine, zinc oxide, cupric oxide, .beta.-carotene, magnesium oxide, doconexent, and icosapent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-225
Packaging
# Item Code Package Description
1 NDC:76439-225-60 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BLISTER PACK 30 
Part 2 1 BLISTER PACK 30 
Part 1 of 2
Virt-BAL DHA Plus 
folic acid, pyridoxine, calcium carbonate, sodium ascorbate, cholecalciferol, acetate ion, thiamine mononitrate, riboflavin, niacinamide, cyanocobalamin, ferrous bisglycinate hydrochloride, iodine, zinc oxide, cupric oxide, .beta.-carotene, and magnesium oxide tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Folic Acid (Folic Acid) Folic Acid 1 mg
Pyridoxine (Pyridoxine) Pyridoxine 50 mg
Calcium Carbonate (Calcium cation) Calcium Carbonate 219 mg
Sodium Ascorbate (Ascorbic Acid) Sodium Ascorbate 120 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 840 [iU]
Acetate Ion (Acetate Ion) Acetate Ion 3 mg
Thiamine Mononitrate (Thiamine Ion) Thiamine Mononitrate 1.8 mg
Riboflavin (Riboflavin) Riboflavin 4 mg
Niacinamide (Niacinamide) Niacinamide 20 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Ferrous Bisglycinate Hydrochloride (Ferrous Cation) Ferrous Bisglycinate Hydrochloride 26.49 mg
Iodine (Iodine) Iodine 220 ug
Zinc Oxide (Zinc Oxide) Zinc Oxide 25 mg
Cupric Oxide (Cupric Oxide) Cupric Oxide 2 mg
.Beta.-Carotene (.Beta.-Carotene) .Beta.-Carotene 2850 [iU]
Magnesium Oxide (Magnesium Cation) Magnesium Oxide 25 mg
Inactive Ingredients
Ingredient Name Strength
Acacia  
Croscarmellose Sodium  
1,2-Dibromo-3-Chloropropane  
Citric Acid Monohydrate  
Magnesium Stearate  
Cellulose, Microcrystalline  
FD&C Blue No. 1  
FD&C Yellow No. 5  
FD&C Yellow No. 6  
Aluminum Oxide  
Hypromelloses  
Polyethylene Glycols  
Polyvinyl Alcohol  
Talc  
Titanium Dioxide  
Povidone K30  
Stearic acid  
Potassium Citrate Anhydrous  
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 20mm
Flavor Imprint Code VTAB
Contains         
Packaging
# Item Code Package Description
1 30 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 07/12/2012
Part 2 of 2
Virt-BAL DHA Plus 
doconexent and icosapent capsule, gelatin coated
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Doconexent (Doconexent) Doconexent 262 mg
Icosapent (Icosapent) Icosapent 112 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin  
.Alpha.-Tocopherol  
Glycerin  
Water  
Sodium Alginate  
Stearic Acid  
Shellac  
Diacetylated Monoglycerides  
Polysorbate 80  
Potassium Sorbate  
Product Characteristics
Color YELLOW (light-yellow) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 30 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 07/12/2012
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: 09/2012
 
Virtus Pharmaceuticals
Hide