FDA.reportPublic FDA data

POLY-VI-FLOR

Manufacturer
Aytu Therapeutics LLC
Effective date
2023-03-14
Label type
DIETARY SUPPLEMENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:50:42

Label at a glance#

ProductPOLY-VI-FLOR
Active ingredientVITAMIN A ACETATE, SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON PENTACARBONYL, SODIUM FLUORIDE
Label structure6 sections

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

Label contents#

Full prescribing information#

Poly-Vi-Flor

STATEMENT OF IDENTITY SECTION

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

Health Claim

HEALTH CLAIM SECTION

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 mcg67%
Vitamin C (as sodium ascorbate)60 mg67%
Vitamin D (as cholecalciferol)10 mcg50 %
Vitamin E (as d-alpha-tocopherol)10 mg67%
Thiamin (as thiamin mononitrate)1 mg83%
Riboflavin1.2 mg92%
Niacin (as niacinamide)10 mg63%
Vitamin B6 (as pyridoxine HCI)1 mg59%
Folate (as Arcofolin®)200 mcg DFE50%
Vitamin B12 (as cyanocobalamin)4.5 mcg188%
Iron (as carbonyl Iron)10 mg56%
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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

SAFE HANDLING WARNING SECTION

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

PACKAGE LABEL.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

0.5 mg with Iron bottle label
0.5 mg with Iron bottle label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23594-525-30POLY-VI-FLOR1 in 1 PACKAGETABLET, CHEWABLE13
23594-525-30POLY-VI-FLOR30 in 1 BOTTLETABLET, CHEWABLE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23594-525POLY-VI-FLOR (MULTIVITAMIN AND FLUORIDE SUPPLEMENT) TABLET, CHEWABLE [AYTU THERAPEUTICS LLC]32 package rows20230328_ccf36095-397e-4574-be72-055794e9cc0a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23594-525-30EA - Each23594-525b7185360-bd20-42a8-8845-1d0e6447ab8912023-04-07

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23594-52523594-525-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A ACETATE3LE3D9D6OYACTIM
SODIUM ASCORBATES033EH8359ACTIM
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL, D-N9PR3490H9ACTIB
THIAMINE MONONITRATE8K0I04919XACTIR
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
CYANOCOBALAMINP6YC3EG204ACTIB
IRON PENTACARBONYL6WQ62TAQ6ZACTIM
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SUCROSEC151H8M554IACT
SORBITOL506T60A25RIACT
FRUCTOSE6YSS42VSEVIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CARRAGEENAN5C69YCD2YJIACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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