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

Vol-Plus by

Drug Labeling and Warnings

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

Drug Details [pdf]

SUPPLEMENT FACTS

Vol-Plus is a prescription vitamin for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation, including women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and non-lactating mothers.

CONTRAINDICATIONS

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

WARNINGS

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 alone is an improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

DRUG 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. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

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.

DESCRIPTION

Vol-Plus is an oval, beige tablet imprinted with “TL519”.

DIRECTIONS FOR USE

Take one tablet daily or as prescribed by a physician.

HOW SUPPLIED

Vol-Plus is supplied in bottles of 100 tablets and bottles of 500 tablets.
Product Code: 13811-519-10 (Bottles of 100 tablets)
Product Code: 13811-519-50 (Bottles of 500 tablets)

STORAGE

Store at room temperature 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP controlled room temperature]. Dispense in a tight, light resistant container as defined by the USP with a child resistant closure. Protect from light and moisture and avoid excessive heat. Note that contact with moisture may produce surface discoloration of the tablet.

SAFE HANDLING WARNING

KEEP OUT OF REACH OF CHILDREN.

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

                                                                                                                                                                                                                       Rev. 07/2018

Customer Service: 1-888-987-4436

                                                                                                                                                                                                                    
Manufactured for:
Trigen Laboratories, LLC
Bridgewater, NJ 08807
www.trigenlab.com

PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label

13811-519-50

Vol-Plus
Tablets

500 TABLETS

TRIGEN
LABORATORIES

PRINCIPAL DISPLAY PANEL- 100 Tablet Bottle Label

13811-519-10

Vol-Plus
Tablets

100 TABLETS

TRIGEN
LABORATORIES

INGREDIENTS AND 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 Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-519
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J)	THIAMINE	1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	500 [iU]
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	3500 [iU]
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	10 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	2 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
CALCIUM SULFATE (UNII: WAT0DDB505) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFATE	200 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-519-01	1000 in 1 BOTTLE, PLASTIC
2	NHRIC:13811-519-10	100 in 1 BOTTLE, PLASTIC
3	NHRIC:13811-519-50	500 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		06/01/2010	02/28/2021

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
scoring	1
shape
size (solid drugs)	22 mm

Labeler - Trigen Laboratories, LLC (830479668)