Virt-bal Dha Plus
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Questions & Answers
Side Effects & Adverse Reactions
| 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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:
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| 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.
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.
Sources
Virt-bal Dha Plus Manufacturers
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Virtus Pharmaceuticals
![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 [Virtus Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Virt-bal Dha Plus | Virtus Pharmaceuticals
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.
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