FDA.reportPublic FDA data

Poly-Vi-Flor with Iron

Manufacturer
Aytu Therapeutics, LLC
Effective date
2021-03-05
Label type
DIETARY SUPPLEMENT
Version
6
Source
full-release
Hydrated at
2026-06-01 02:49:58

Label at a glance#

ProductPoly-Vi-Flor with Iron
Active ingredientCHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE CALCIUM, FERRIC CITRATE ANHYDROUS, SODIUM FLUORIDE
Label structure6 sections

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

Multivitamin and Fluoride Supplement

Supplement Facts
Serving Size 1 mL • Servings Per Container 50
% Daily Value
Amount Per 1 mLInfants
through
12 months		Children
1 through 3
years of age
vitamin D (as cholecalciferol)10 mcg100%67%
vitamin E (as d-alpha-tocopheryl acetate)3.35 mg67%56%
niacin (as niacinamide)8 mg200%133%
vitamin B6 (as pyridoxine HCl)0.4 mg133%80%
folate (from Metafolin®)230 mcg DFE288%153%
iron (as ferric citrate)7 mg64%100%
fluoride (as sodium fluoride)0.25 mg**

*Daily Value not established

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

U.S. Patent Numbers: 5,997,915; 6,254,904; 6,011,040; 6,441,168

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

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

WARNING

WARNINGS SECTION

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.

How to Use the Enclosed Dropper

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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 SECTION

Shake well before use.

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

WARNING

WARNINGS SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

23594-600-50

Poly-Vi-Flor with Iron®

Essential Vitamins for Infants & Toddlers

FRUITY FLAVOR

MULTIVITAMIN AND FLUORIDE SUPPLEMENT

0.25 mg with iron

NOT SUBSTITUTABLE

CONTAINS: METAFOLIN

1 2/3 FL OZ (50 mL)

AYTU Bioscience

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

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
FERRIC CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23594-600-50Poly-Vi-Flor with Iron50 mL in 1 BOTTLESUSPENSION/ DROPS506
23594-600-50Poly-Vi-Flor with Iron1 in 1 PACKAGESUSPENSION/ DROPS16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23594-600POLY-VI-FLOR WITH IRON (MULTIVITAMIN AND FLUORIDE SUPPLEMENT) SUSPENSION/ DROPS [AYTU THERAPEUTICS, LLC]62 package rows20210424_48fe69bc-e163-4cac-bd35-2052222f39fa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23594-600-50ML - Milliliter23594-6004385d6f7-0766-42b3-bb5d-b77c39c8aa9f12016-10-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23594-60023594-600-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NACTIM
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
LEVOMEFOLATE CALCIUMA9R10K3F2FACTIM
FERRIC CITRATE ANHYDROUS63G354M39ZACTIM
SODIUM FLUORIDE8ZYQ1474W7ACTIM
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
FRUCTOSE6YSS42VSEVIACT
XYLITOLVCQ006KQ1EIACT
POLYSORBATE 806OZP39ZG8HIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.