POLY-VI-FLOR- multivitamin and fluoride supplement tablet, chewable

POLY-VI-FLOR by

Drug Labeling and Warnings

POLY-VI-FLOR by is a Other medication manufactured, distributed, or labeled by Aytu Therapeutics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Poly-Vi-Flor

(Multivitamin with 0.5 mg of Fluoride and 10 mg Iron) Chewable Tablet

Health Claim

Multivitamin and Fluoride Supplement

Supplement Facts; Serving Size 1 Tablet; Servings Per Container 30
Amount Per Serving		% Daily Value; for Adults and Children; 4 or More Years of Age
Vitamin A (as retinyl acetate)	600 mcg	67%
Vitamin C (as sodium ascorbate)	60 mg	67%
Vitamin D (as cholecalciferol)	10 mcg	50 %
Vitamin E (as d-alpha-tocopherol)	10 mg	67%
Thiamin (as thiamin mononitrate)	1 mg	83%
Riboflavin	1.2 mg	92%
Niacin (as niacinamide)	10 mg	63%
Vitamin B6 (as pyridoxine HCI)	1 mg	59%
Folate (as Arcofolin®)	200 mcg DFE	50%
Vitamin B12 (as cyanocobalamin)	4.5 mcg	188%
Iron (as carbonyl Iron)	10 mg	56%
Fluoride (as sodium fluoride)	0.5 mg	*
*Daily Value not established

Ingredients: Sucrose, Sorbitol, Fructose, Citric Acid, Beet Root Juice, Carrageenan USP, Grape Flavor, Raspberry Flavor, Stearic Acid, Cherry Flavor, Magnesium Stearate, Sucralose.

Allergen Warning: Contains fish gelatin and soy oil.

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.

Dosage and Administration

Caution: This product should be chewed and is not recommended for children under age 4 due to risk of choking.

Dispense under a physician's order

Safe Handling Warning

Arcoflin® is a registered trademark of Merck KGaA, Darmstadt, Germany

Distributed by:
Aytu Therapeutics, LLC
Englewood, CO 80112
1-855-298-8246
www.aytubio.com

Principal Display Panel

23594-525-30

Poly-Vi-Flor®

(Multivitamin with 0.5 mg of Fluoride an 10 mg Iron) Chewable Tablet

MULTIVITAMIN & FLUORIDE SUPPLEMENT

BERRY FLAVOR

0.5 mg

30 Tablets

CONTAINS:ARCOFOLIN®

AYTU BIOPHARMA

Dispense under a physician’s order

INGREDIENTS AND APPEARANCE

POLY-VI-FLOR 
multivitamin and fluoride supplement tablet, chewable

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:23594-525
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	600 ug
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	60 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	10 ug
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	10 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J)	THIAMINE	1 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.2 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	10 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	4.5 ug
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	10 mg
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
SORBITOL (UNII: 506T60A25R)
FRUCTOSE (UNII: 6YSS42VSEV)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARRAGEENAN (UNII: 5C69YCD2YJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:23594-525-30	1 in 1 PACKAGE
1		30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		03/14/2023

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
flavor
scoring	1
shape
size (solid drugs)	10 mm

Labeler - Aytu Therapeutics LLC (117244733)