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VOL-PLUS (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
[Trigen Laboratories, Inc.]



Rx Only

DESCRIPTION

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.

Supplement Facts
Servings per Bottle: 500
Serving Size: 1 tablet
Each tablet contains:
% DV Adults & Children
4 Years or More
Folic Acid1 mg250%
Vitamin A (Input as vitamin A acetate and beta carotene) 4000 IU80%
Vitamin C (ascorbic acid) 120 mg200%
Calcium (calcium sulfate)200 mg20%
Iron (ferrous fumarate)27 mg150%
Vitamin D3 (cholecalciferol) 400 IU100%
Vitamin E (dl-alpha-tocopheryl acetate) 22 mg157%
Vitamin B1 (thiamine mononitrate) 1.84 mg123%
Vitamin B2 (riboflavin) 3 mg176%
Niacinamide (vitamin B3)20 mg100%
Vitamin B6 (pyridoxine HCl) 10 mg500%
Vitamin B12 (cyanocobalamin) 12 mcg200%
Zinc (zinc oxide)25 mg167%
Copper (cupric oxide)2 mg100%

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.

CONTRAINDICATIONS

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

WARNINGS SECTION

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.

PRECAUTIONS

General

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.

PATIENT INFORMATION

Vol-Plus is a prescription vitamin for the use only under the direction and supervision of a licensed physician.

INTERACTIONS

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.

ADVERSE REACTIONS

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.

Ferrous Fumarate

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.

HOW SUPPLIED

Vol-Plus is supplied as:
Bottles of 100 tablets: 13811-519-10
Bottles of 500 tablets: 13811-519-50

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN

Rx Only

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com

Rev. 04/13

PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label

13811-519-50
Rx Only

Vol-Plus
Tablets

500 TABLETS

TRIGEN
LABORATORIES

Principal Display Panel - 500 Tablet Bottle Label

INGREDIENTS & APPEARANCE

VOL-PLUS 
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
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-519
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Folic Acid (Folic Acid) Folic Acid1 mg
ascorbic acid (ascorbic acid) ascorbic acid120 mg
thiamine mononitrate (THIAMINE ION) THIAMINE1.84 mg
riboflavin (riboflavin) riboflavin3 mg
pyridoxine Hydrochloride (PYRIDOXINE) pyridoxine Hydrochloride10 mg
cyanocobalamin (cyanocobalamin) cyanocobalamin12 ug
niacinamide (niacinamide) niacinamide20 mg
vitamin A acetate (VITAMIN A) VITAMIN A500 [iU]
.beta.-carotene (.beta.-carotene) .beta.-carotene3500 [iU]
cholecalciferol (cholecalciferol) cholecalciferol400 [iU]
.alpha.-tocopherol acetate, dl- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL-22 mg
cupric oxide (CUPRIC CATION) CUPRIC CATION2 mg
zinc oxide (zinc oxide) zinc oxide25 mg
ferrous fumarate (FERROUS CATION) FERROUS CATION27 mg
calcium sulfate (CALCIUM CATION) calcium sulfate200 mg
Inactive Ingredients
Ingredient NameStrength
cellulose, microcrystalline 
hypromelloses 
polyvinyl alcohol 
titanium dioxide 
polyethylene glycols 
talc 
FD&C yellow No. 6 
FD&C blue No. 2 
acacia 
povidone K30 
Calcium Phosphate, Dibasic, Anhydrous 
croscarmellose sodium 
potassium citrate anhydrous 
citric acid monohydrate 
magnesium stearate 
stearic acid 
ascorbyl palmitate 
Product Characteristics
ColorWHITE (beige) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code TL519
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:13811-519-10100 in 1 BOTTLE, PLASTIC
2NHRIC:13811-519-50500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT06/01/2010
Labeler - Trigen Laboratories, Inc. (830479668)

Revised: 5/2013
 
Trigen Laboratories, Inc.