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

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Poly-Vi-Flor with Iron

Multivitamin and Fluoride Supplement

Supplement Facts
Serving Size 1 mL Dropperful Daily
Servings Per Container - 50
% Daily Value
Amount Per 1 mLInfantsChildren Under Age 4 Years
Vitamin D3 (as Cholecalciferol) 400 IU100%100%
Vitamin E (as Alpha Tocopheryl Acetate) 5 IU100%50%
Vitamin B1 (as Thiamine HCl) 0.5 mg100%71%
Vitamin B2 (as Riboflavin) 0.6 mg100%75%
Niacin (Vitamin B3) (as Niacinamide) 8 mg100%89%
Vitamin B6 (as Pyridoxine HCl) 0.4 mg100%57%
Folate (as Calcium L-methylfolate (Metafolin®)) 200 mcg162%81%
Iron (as Ferric Saccharate, with Alginates) 7 mg47%70%
Fluoride (as sodium fluoride) 0.25 mg**

*U.S. Recommended Daily Allowance has not been established

OTHER INGREDIENTS: Glycerin, Water, Fructose, Xylitol, Polysorbate 80, Natural Flavoring, Citric Acid, Soy Lecithin, Potassium Sorbate, Sodium Benzoate

Distributed by: Zylera Pharmaceuticals
Research Triangle Park, NC 27713

U.S. Patent No. 5,997,915 • U.S. Patent No. 6,254,904
U.S. Patent No. 6,011,040 • U.S. Patent No. 6,441,168

Metafolin® is a registered trademark of Merck KGaA, Darmstadt, Germany *CAS# 151533-22-1

QUESTIONS OR COMMENTS? Please call Zylera Medical Affairs at 1-866-416-9637

WARNING

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a poison control center immediately.

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.

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 medicines, keep out of the reach of children.

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

23594-600-50

Poly-Vi-Flor with Iron

Essential Vitamins for Infants & Toddlers

FRUITY FLAVOR

MULTIVITAMIN AND FLUORIDE SUPPLEMENT

0.25 mg with iron

NEW FORMULATION
NOT SUBSTITUTABLE

CONTAINS: METAFOLIN

1 2/3 FL OZ (50 mL)

Zylera Pharmaceuticals

Poly-Vi-Flor with Iron and 0.25 mg of Fluoride

POLY-VI-FLOR WITH IRON 
multivitamin and fluoride supplement suspension/ drops
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:23594-600
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]  in 50 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE5 [iU]  in 50 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE0.5 mg  in 50 mL
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.6 mg  in 50 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE8 mg  in 50 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE0.4 mg  in 50 mL
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID200 ug  in 50 mL
IRON SUCROSE (UNII: FZ7NYF5N8L) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION7 mg  in 50 mL
FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
FRUCTOSE (UNII: 6YSS42VSEV)  
XYLITOL (UNII: VCQ006KQ1E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:23594-600-501 in 1 PACKAGE
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement09/01/2016
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
flavor
Labeler - Aytu Therapeutics, LLC (117244733)

Revised: 4/2019
Document Id: 95d4414b-72af-44e1-90e1-76cbecec8aab
Set id: 48fe69bc-e163-4cac-bd35-2052222f39fa
Version: 5
Effective Time: 20190408
 
Aytu Therapeutics, LLC