POLY-VI-FLOR- multivitamin and fluoride supplement suspension/ drops 
Aytu Therapeutics LLC

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Poly-Vi-Flor 0-25 mg Drops

Poly-Vi-Flor

(Multivitamin with 0.25 mg of Fluoride)

Poly-Vi-Flor Drop are specifically designed to help meet the nutritional needs of your growing infant or toddler.

Health Claim

Multivitamin and Fluoride Supplement

Supplement Facts
Serving Size 1 mL • Servings Per Container 50
  % Daily Value
 Amount Per 1 mL Infants
through
12 months
 Children
1 through 3
years of age
 vitamin D (as cholecalciferol) 10 mcg 100%67%
 vitamin E (as d-alpha-tocopheryl acetate) 3.35 mg 67%56%
 niacin (as niacinamide) 8 mg 200%133%
 vitamin B6 (as pyridoxine HCl) 0.4 mg133%80%
 folate (from Metafolin®) 200 mcg DFE250%133%
 fluoride (as sodium fluoride) 0.25 mg* *

*Daily Value not established

Ingredients: Glycerin, Water, Fructose, Ascorbic Acid, Polysorbate 80, Natural Flavoring, Soy Lecithin, Potassium Sorbate

Dosage and Administration

How to Use the Enclosed Dropper

Fill the dropper to the 1 mL line to provide the full daily dosage. Use full dosage, regardless of age or weight, unless your child's doctor recommends a different dosage.

Dispense with a single squeeze of the dropper bulb.  It is normal for a small amount to remain in the tip.

Dosing Tips

Drops may be given by dispensing directly into the mouth. Drops may also be mixed with formula, fruit juice, cereal or other foods to increase your child's acceptance.

Shake well before use.

This product comes with a child-resistant cap. Refrigeration not required. After opening, store away from direct sunlight.

Warning

As with all medicines, keep out of the reach of children.

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

Distributed by: Aytu Therapeutics, LLC
Denver, CO80237
1-855-298-8246
www.aytubio.com

Principal Display Panel

PRINCIPAL DISPLAY PANEL - Poly-Vi-Flor with 0.25 mg of Fluoride

23594-550-50

Poly-Vi-Flor®

Essential Vitamins for Infants & Toddlers

FRUITY FLAVOR

MULTIVITAMIN AND FLUORIDE SUPPLEMENT

0.25 mg

NOT SUBSTITUTABLE

CONTAINS: METAFOLIN

1 2/3 FL OZ (50 mL)

Aytu BioPharma

Dispense under a physician’s order

Bottle Label

Bottle Label

Carton Label

Carton Label

POLY-VI-FLOR 
multivitamin and fluoride supplement suspension/ drops
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:23594-550
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug  in 1 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-3.35 mg  in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE8 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE0.4 mg  in 1 mL
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID200 ug  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
FRUCTOSE (UNII: 6YSS42VSEV)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:23594-550-501 in 1 PACKAGE
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT12/23/2022
Labeler - Aytu Therapeutics LLC (117244733)

Revised: 3/2023
Document Id: 03f6ee03-8ba5-4835-9bcd-e92edcfd525d
Set id: 9cbce9a0-64f9-4841-9ae9-c4901b2a3ba1
Version: 4
Effective Time: 20230327
 
Aytu Therapeutics LLC