FULL PRESCRIBING INFORMATION: CONTENTS*
- INDICATIONS AND USAGE
- PATIENT INFORMATION
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label
FULL PRESCRIBING INFORMATION
Vol-Plus is an orally administered prescription vitamin for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. Vol-Plus is an oval, beige tablet with "TL519" debossed on one side.
Servings per Bottle: 500
|Serving Size: 1 tablet
Each tablet contains:
|% DV Adults & Children
4 Years or More
|Folic Acid||1 mg||250%|
|Vitamin A (Input as vitamin A acetate and beta carotene)||4000 IU||80%|
|Vitamin C (ascorbic acid)||120 mg||200%|
|Calcium (calcium sulfate)||200 mg||20%|
|Iron (ferrous fumarate)||27 mg||150%|
|Vitamin D3 (cholecalciferol)||400 IU||100%|
|Vitamin E (dl-alpha-tocopheryl acetate)||22 mg||157%|
|Vitamin B1 (thiamine mononitrate)||1.84 mg||123%|
|Vitamin B2 (riboflavin)||3 mg||176%|
|Niacinamide (vitamin B3)||20 mg||100%|
|Vitamin B6 (pyridoxine HCl)||10 mg||500%|
|Vitamin B12 (cyanocobalamin)||12 mcg||200%|
|Zinc (zinc oxide)||25 mg||167%|
|Copper (cupric oxide)||2 mg||100%|
Inactive Ingredients: Microcrystalline Cellulose, Beige Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, FD&C Yellow #6 Lake, FD&C Blue #2 Lake), Pregelatinized Starch, Croscarmellose Sodium, Di Calcium Phosphate, Magnesium Stearate, Stearic Acid, Fumed Silica, Ascorbyl Palmitate.
INDICATIONS AND USAGE
Vol-Plus is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
|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.|
Folic acid, when prescribed as a single agent in doses above 0.1 mg daily, may obscure the detection of 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). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.
Vol-Plus is a prescription vitamin for the use only under the direction and supervision of a licensed physician.
Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
Drugs which may interact with folate include:
- Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, 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 levels of this AED in the blood and allowing breakthrough seizures to occur.
- 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.
- 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.
- Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
- 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.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates - including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.
Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy and physician encouragement. Although, the absorption of iron is best when taken between meals, occasional gastrointestinal disturbances may be controlled giving Vol-Plus shortly after meals.
DOSAGE AND ADMINISTRATION
Before, during and after pregnancy, one tablet daily, or as prescribed by a physician.
|Vol-Plus is supplied as:|
|Bottles of 100 tablets: 13811-519-10|
|Bottles of 500 tablets: 13811-519-50|
KEEP OUT OF REACH OF CHILDREN
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label
Folic Acid, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine Hydrochloride, cyanocobalamin, niacinamide, vitamin A acetate, .beta.-carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, cupric oxide, zinc oxide, ferrous fumarate, and calcium sulfate TABLET, COATED