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: Vitamin A (beta carotene) 2850 IU Vitamin C (ascorbic acid) 120 mg Vitamin D 3 (cholecalciferol) 840 IU Vitamin E (dl-alpha tocopherol acetate) 3 mg Vitamin B 1 (thiamine mononitrate) 1.8 mg Vitamin B 2 (riboflavin) 4 mg Vitamin B 3 (niacinamide) 20 mg Vitamin B 6 (pyridoxine HCl) 50 mg Folate Folates are B vitamins necessary for methylation and DNA/RNA synthesis. Variant forms of vitamin B 9 - such as folinic or folic acid, are necessary to reduce the risk of Neural Tube Defects (NTDs) during the first trimester of pregnancy. 1 mg Vitamin B 12 (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 B 9 , 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 B 12 dependent methylation cycle. Folic acid, including reduced forms 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. 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).