POLY-VI-FLOR WITH IRON- multivitamin and fluoride supplement suspension/ drops

Poly-Vi-Flor with Iron by

Drug Labeling and Warnings

Poly-Vi-Flor with Iron 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 with Iron

HEALTH CLAIM

Multivitamin and Fluoride Supplement

Supplement Facts
Serving Size 1 mL Dropperful Daily Servings Per Container - 50
	% Daily Value
Amount Per 1 mL	Infants	Children Under Age 4 Years
Vitamin D3 (as Cholecalciferol) 400 IU	100%	100%
Vitamin E (as Alpha Tocopheryl Acetate) 5 IU	100%	50%
Vitamin B1 (as Thiamine HCl) 0.5 mg	100%	71%
Vitamin B2 (as Riboflavin) 0.6 mg	100%	75%
Niacin (Vitamin B3) (as Niacinamide) 8 mg	100%	89%
Vitamin B6 (as Pyridoxine HCl) 0.4 mg	100%	57%
Folate (as Calcium L-methylfolate (Metafolin®)) 200 mcg	162%	81%
Iron (as Ferric Saccharate, with Alginates) 7 mg	47%	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.

SAFE HANDLING WARNING

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

INGREDIENTS AND APPEARANCE

POLY-VI-FLOR WITH IRON 
multivitamin and fluoride supplement suspension/ drops

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:23594-600
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]  in 50 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	5 [iU]  in 50 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	0.5 mg  in 50 mL
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	0.6 mg  in 50 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	8 mg  in 50 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	0.4 mg  in 50 mL
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	200 ug  in 50 mL
IRON SUCROSE (UNII: FZ7NYF5N8L) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	7 mg  in 50 mL
FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.25 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:23594-600-50	1 in 1 PACKAGE
1		50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		09/01/2016

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
flavor

Labeler - Cerecor, Inc. (968799028)