V-NATAL- folic acid, pyridoxine, calcium formate, calcium carbonate, sodium ascorbate, cholecalciferol, acetate ion, thiamine mononitrate, riboflavin, niacinamide, cyanocobalamin, ferrous bisglycinate, potassium iodide, zinc oxide, and choline bitartrate tablet, coated
Virtus Pharmaceuticals
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.
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V-Natal Tabs is an orally administered PRENATAL / POSTNATAL prescription folate specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.
V-Natal Tabs should be administered under the supervision of a licensed medical practitioner.
Each oval, pink film-coated tablet contains the following dietary ingredients:
Vitamin C (sodium ascorbate) | 120 mg | |
Vitamin D3 (cholecalciferol) | 450 IU | |
Vitamin E (acetate) | 30 IU | |
Vitamin B1 (thiamine mononitrate) | 3 mg | |
Vitamin B2 (riboflavin) | 3 mg | |
Vitamin B3 (niacinamide) | 20 mg | |
Vitamin B6 (pyridoxine HCl) | 50 mg | |
Folate | 1000 mcg | |
Vitamin B12 (cyanocobalamin) | 10 mcg | |
Calcium | 200 mg | |
as calcium formate | 155 mg | |
as calcium carbonate | 45 mg | |
Iron (ferrous (II) bisglycinate chelate) | 32 mg | |
Iodine (potassium iodide) | 100 mcg | |
Zinc (zinc oxide) | 10 mg | |
Choline (choline bitartrate) | 55 mg |
Acacia, Citric Acid, Croscarmellose Sodium, Crospovidone, Fumed Silica, Hydroxpropyl Cellulose, Magnesium Stearate, Microcrystalline Cellulose, Pink Coating (FD&C Red #40 Lake, Hydroxypropylmethyl Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Sucralose, Talc, Titanium Dioxide), Polyvinylpyrrolidone, Silicon Dioxide, Stearic Acid, TriPotassium Citrate.
Since colors, flavors of natural origin vary from batch to batch in consistency - it may be necessary to substitute excipients as needed to ensure the highest therapeutic target, safety and quality.
Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
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 polymorphisms 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.
V-Natal Tabs is indicated for the distinct nutritional requirements of patients in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner. V-Natal Tabs is also indicated as supplementation therapy during pre/post pregnancy as well as while lactating / non-lactating.
V-Natal Tabs should be administered under the supervision of a licensed medical practitioner.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
See product ingredients. Consult your licensed healthcare practitioner or pharmacist for more information.
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.
V-Natal Tabs is a PRENATAL / POSTNATAL prescription folate to be used only under licensed medical supervision.
Drugs which may interact with folate2 include:
Drugs which interact with vitamin B12:
Drugs which interact with vitamin B6:
Drugs which may interact with vitamin D3:
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.
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.
V-Natal Tabs is supplied as oval, pink film-coated tablets debossed on one side with "VTAB", dispensed in bottles of 90 tablets.
Product Code: 76439-226-90
*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.
V-NATAL
folic acid, pyridoxine, calcium formate, calcium carbonate, sodium ascorbate, cholecalciferol, acetate ion, thiamine mononitrate, riboflavin, niacinamide, cyanocobalamin, ferrous bisglycinate, potassium iodide, zinc oxide, and choline bitartrate tablet, coated |
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Labeler - Virtus Pharmaceuticals (969483143) |