VP-ZEL- niacinamide, azelaic acid, zinc, pyridoxine, cupric oxide, and folic acid 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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VP-ZEL Tabs is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels and nutritional supplementation.
VP-ZEL Tabs should be administered under the supervision of a licensed medical practitioner.
Each coated, purple colored, oval-shaped tablet contains the following dietary ingredients:
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Supplement Facts | ||
Serving Size: 1 Pill | Servings Per Container: 60 | |
Amount Per Serving | % Daily Value | |
Nicotinamide (Vitamin B3) | 600 mg | * |
Azelaic Acid† | 5 mg | * |
Zinc (Zinc Oxide) | 10 mg | * |
Pyridoxine (Vitamin B6) | 5 mg | * |
Copper (Cupric Oxide) | 1.5 mg | * |
Folic acid | 500 mcg | * |
Other ingredients: Microcrystalline cellulose, dicalcium phosphate, croscarmellose sodium, stearic acid, magnesium stearate, silica, and film coat (polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, FD&C blue #1 lake, and FD&C red #3).
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:
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).
VP-ZEL Tabs is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. VP-ZEL 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.
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.
VP-ZEL Tabs is a prescription dietary supplement to be used only under licensed medical supervision.
Drugs which may interact with folate include:
Drugs which may interact with nicotinamide:
Drugs which may interact with zinc oxide:
Drugs which may interact with cupric oxide:
Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate.
Usual adult dose is one or two tablets taken once or twice a day with or without food or as directed by a licensed medical practitioner.
VP-ZEL Tabs tablets are coated, purple colored, oval-shaped tablets debossed on one side with "V221", and are supplied in bottles of 60 tablets.
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Call your licensed medical practitioner about side effects.
You may report side effects by calling 813-283-1344.
NDC2: 76439-221-60
VP-ZEL Tabs
Tablets
60ct Bottle
Rx
Prescription Dietary Supplement
Manufactured for:
Virtus Pharmaceuticals
Tampa, FL 33619
MADE IN USA
Rev. 12/11
VP-ZEL
niacinamide, azelaic acid, zinc, pyridoxine, cupric oxide, and folic acid tablet, coated |
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Labeler - Virtus Pharmaceuticals (969483143) |