Vol-Tab Rx by Trigen Laboratories, Inc. Vol-Tab RxTablets

Vol-Tab Rx by

Drug Labeling and Warnings

Vol-Tab Rx by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VOL-TAB RX- folic acid, .beta.-carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, potassium iodide, zinc oxide, magnesium oxide, iron pentacarbonyl, and cupric oxide tablet, film coated 
Trigen Laboratories, LLC

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Vol-Tab Rx
Tablets

Rx Only

DESCRIPTION

Vol-Tab Rx is supplied as an oval, white tablet with "TL516" debossed on one side. Vol-Tab is an orally administered prescription vitamin for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

Supplement Facts
Servings per Bottle: 90
Serving Size: 1 Tablet%DV Adults and Children
Each Tablet contains4 Years or More
Folic Acid1 mg250%
Vitamin A (beta carotene)4000 IU80%
Vitamin D3 (cholecalciferol)400 IU100%
Vitamin E (dl-alpha-tocopheryl acetate)30 IU100%
Vitamin C (ascorbic acid)120 mg200%
Vitamin B1 (thiamine mononitrate)3 mg200%
Vitamin B2 (riboflavin)3 mg177%
Niacin (niacinamide)20 mg100%
Vitamin B6 (pyridoxine HCl)3 mg150%
Vitamin B12 (cyanocobalamin)8 mcg133%
Biotin30 mcg10%
Pantothenic Acid (calcium pantothenate)7 mg70%
Calcium (calcium carbonate)200 mg20%
Iodine (potassium iodide)150 mcg100%
Zinc (zinc oxide)15 mg100%
Magnesium (magnesium oxide)100 mg25%
Iron (carbonyl iron)29 mg161%
Copper (cupric oxide)3 mg150%

Inactive Ingredients: Microcrystalline Cellulose, Coating (Hypromellose, Titanium Dioxide, Polyvinyl Alcohol, Polyethylene Glycol, Talc), Tripotassium Citrate, Acacia, Citric Acid, Croscarmellose Sodium, Povidone K30, Magnesium Stearate, Stearic Acid, Fumed Silica.

INDICATIONS AND USAGE

Vol-Tab Rx 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.

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-Tab Rx is a prescription vitamin for 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 occured 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 cyanococobalamin.

DOSAGE AND ADMINISTRATION

One tablet daily, or as prescribed by a physician.

HOW SUPPLIED

Vol-Tab Rx is dispensed in bottles of 90 tablets. PRODUCT CODE 13811-516-90

KEEP OUT OF REACH OF CHILDREN.
Rx Only

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

Rev. 02/13

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

13811-516-90
Rx Only

Vol-Tab Rx
Tablets

90 TABLETS

TRIGEN
LABORATORIES

Principal Display Panel - 90 Tablet Bottle Label
VOL-TAB RX 
folic acid, .beta.-carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, potassium iodide, zinc oxide, magnesium oxide, iron pentacarbonyl, and cupric oxide tablet, film coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-516
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
.beta.-carotene (UNII: 01YAE03M7J) (.beta.-carotene - UNII:01YAE03M7J) .beta.-carotene4000 [iU]
cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41) cholecalciferol400 [iU]
.alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.alpha.-tocopherol, dl- - UNII:7QWA1RIO01) .alpha.-tocopherol, dl-30 [iU]
ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid120 mg
thiamine mononitrate (UNII: 8K0I04919X) (thiamine ion - UNII:4ABT0J945J) thiamine3 mg
riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR) riboflavin3 mg
niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4) niacinamide20 mg
pyridoxine hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z) pyridoxine hydrochloride3 mg
cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin8 ug
biotin (UNII: 6SO6U10H04) (biotin - UNII:6SO6U10H04) biotin30 ug
calcium pantothenate (UNII: 568ET80C3D) (pantothenic acid - UNII:19F5HK2737) pantothenic acid7 mg
calcium carbonate (UNII: H0G9379FGK) (calcium cation - UNII:2M83C4R6ZB) calcium carbonate200 mg
potassium iodide (UNII: 1C4QK22F9J) (iodide ion - UNII:09G4I6V86Q) potassium iodide150 ug
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide15 mg
magnesium oxide (UNII: 3A3U0GI71G) (magnesium cation - UNII:T6V3LHY838) magnesium oxide100 mg
iron pentacarbonyl (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 mg
cupric oxide (UNII: V1XJQ704R4) (cupric cation - UNII:8CBV67279L) cupric cation3 mg
Inactive Ingredients
Ingredient NameStrength
cellulose, microcrystalline (UNII: OP1R32D61U)  
hypromelloses (UNII: 3NXW29V3WO)  
titanium dioxide (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
talc (UNII: 7SEV7J4R1U)  
potassium citrate anhydrous (UNII: 86R1NVR0HW)  
acacia (UNII: 5C5403N26O)  
croscarmellose sodium (UNII: M28OL1HH48)  
povidone K30 (UNII: U725QWY32X)  
magnesium stearate (UNII: 70097M6I30)  
stearic acid (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:13811-516-3090 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT06/01/201008/31/2019
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
imprint
scoring1
shape
size (solid drugs)19 mm
Labeler - Trigen Laboratories, LLC (830479668)

Revised: 11/2019