FDA.reportPublic FDA data

Poly-Vi-Flor Gummies

Manufacturer
Aytu Therapeutics LLC
Effective date
2022-12-12
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:37

Label at a glance#

ProductPoly-Vi-Flor Gummies
Active ingredientVITAMIN A PALMITATE, SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, NIACIN, CYANOCOBALAMIN, SODIUM FLUORIDE, FOLIC ACID
Label structure5 sections

Label contents#

Full prescribing information#

Poly-Vi-Flor

STATEMENT OF IDENTITY SECTION

(Multivitamin with 0.5 mg of Fluoride) Chewable Gummie

Multivitamin and Fluoride Supplement

HEALTH CLAIM SECTION

Supplement Facts

Serving Size 1 Gummie

Servings Per Gummie 30

 Amount Per Serving   % Daily Value
for Adults and Children
4 or More Years of Age
 Vitamin A (as retinyl palmitate) 600 mcg 67%
 Vitamin C (as ascorbic acid) 60 mg 67%
 Vitamin D (as cholecalciferol) 15 mcg 75%
 Vitamin E (as d-alpha tocopherol acetate) 10 mg 67%
 Niacin (as Nicotinic Acid) 10 mg 63%
 Folate (as Arcofolin®) 230 mcg DFE 58%
 Vitamin B12 (as cyanocobalamin) 4.5 mcg 188%
 Fluoride (as sodium fluoride) 0.5 mg *

*Daily Value not established

Ingredients: Corn Syrup (Glucose), Sugar, Water, Pectin, Sodium Citrate, Citric Acid, Mixed Berry Natural Flavor, Natural Masking Agent, Red 40

Allergen Warning: Contains fish gelatin and soy oil

DOSAGE & ADMINISTRATION SECTION

Caution: This product should be chewed and is not recommended for children under age 4 due to risk of choking.

SAFE HANDLING WARNING SECTION

Arcofolin® 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 - MultiVitamin with 0.5 MG of Fluoride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

23594-350-30

Poly-Vi-Flor®

(Multivitamin with 0.5 mg of Fluoride) Chewable Gummie

MULTIVITAMIN & FLUORIDE SUPPLEMENT

BERRY FLAVOR

0.5 mg

30 Gummies

CONTAINS:ARCOFOLIN

AYTU BIOPHARMA

0.5 mg Gummies Label
0.5 mg Gummies 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
NIACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23594-350-30Poly-Vi-Flor Gummies30 in 1 BOTTLETABLET, CHEWABLE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23594-350POLY-VI-FLOR GUMMIES (MULTIVITAMIN AND FLUORIDE SUPPLEMENT) TABLET, CHEWABLE [AYTU THERAPEUTICS LLC]21 package rows20221217_de449343-5ad6-4684-bb4a-0646fc60901a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23594-350-30EA - Each23594-350edb4bd4d-2a08-461c-98f3-851ebc5b824c12023-01-09

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23594-35023594-350-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A PALMITATE1D1K0N0VVCACTIM
SODIUM ASCORBATES033EH8359ACTIM
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL, D-N9PR3490H9ACTIB
NIACIN2679MF687AACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
FOLIC ACID935E97BOY8ACTIB
CORN SYRUP9G5L16BK6NIACT
WATER059QF0KO0RIACT
PECTIN89NA02M4RXIACT
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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