FDA.reportPublic FDA data

Poly-Vi-Flor 0.25 mg Arcofolin Drops

Manufacturer
Aytu Therapeutics LLC
Effective date
2023-08-11
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:52

Label at a glance#

ProductPOLY-VI-FLOR
Active ingredientCHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE CALCIUM, SODIUM FLUORIDE
Label structure5 sections

Dosage and administration

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 of the dropper bulb.  It is normal for a small amount to remain in the tip. Dosing Tips Drops may be given by dispensing directly into the mouth. Drops may also be mixed with formula...

Label contents#

Full prescribing information#

Poly-Vi-Flor

STATEMENT OF IDENTITY SECTION

(Multivitamin and Fluoride Supplement with 0.25 mg of Fluoride)

Health Claim

HEALTH CLAIM SECTION

Multivitamin and Fluoride Supplement

Supplement Facts
Serving Size 1 mL • Servings Per Container 50
  % Daily Value
 Amount Per 1 mL Infants
through
12 months		 Children
1 through 3
years of age
 vitamin D (as cholecalciferol) 10 mcg 100%67%
 vitamin E (as d-alpha-tocopheryl acetate) 3.35 mg 67%56%
 niacin (as niacinamide) 8 mg 200%133%
 vitamin B6 (as pyridoxine HCl) 0.4 mg133%80%
 folate (as Arcofolin) 200 mcg DFE250%133%
 fluoride (as sodium fluoride) 0.25 mg* *

*Daily Value not established

Ingredients: Glycerin, Water, Fructose, Ascorbic Acid, Polysorbate 80, Natural Flavoring, Soy Lecithin, Potassium Sorbate

Poly-Vi-Flor drops are specially designed to help meet the nutritional needs of your growing infant or toddler.

  • Poly-Vi-Flor Drops are the ideal vitamin supplement during your child's transition to solid foods, during growth spurts, or for the picky eater.
  • One daily dose of Poly-Vi-Flor Drops provides 7 essential vitamins and is fruit flavored.
  • Drops are dye-free and gluten-free.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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 of the dropper bulb.  It is normal for a small amount to remain in the tip.

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

SAFE HANDLING WARNING SECTION

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

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

23594-805-50

Poly-Vi-Flor®

Essential Vitamins for Infants & Toddlers

FRUITY FLAVOR

MULTIVITAMIN AND FLUORIDE SUPPLEMENT DROPS

0.25 mg

NOT SUBSTITUTABLE

CONTAINS:Arcofolin

1 2/3 FL OZ (50 mL)

Aytu Therapeutics, LLC

Arcofolin Drops .25mg
Arcofolin Drops .25mg
Poly-Vi-Flor 0.25mg Arco Carton
Poly-Vi-Flor 0.25mg Arco Carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - 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
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23594-805-50POLY-VI-FLOR50 mL in 1 BOTTLESUSPENSION/ DROPS502
23594-805-50POLY-VI-FLOR1 in 1 PACKAGESUSPENSION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23594-805POLY-VI-FLOR (MULTIVITAMIN AND FLUORIDE SUPPLEMENT) SUSPENSION/ DROPS [AYTU THERAPEUTICS LLC]22 package rows20230812_8f27e4e1-97a8-4172-a74f-1cd167d2b522.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23594-805-50ML - Milliliter23594-805c16f3d27-63d0-4744-b41a-23c82e1b602812023-10-16

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23594-80523594-805-50

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
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NACTIM
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
LEVOMEFOLATE CALCIUMA9R10K3F2FACTIM
SODIUM FLUORIDE8ZYQ1474W7ACTIM
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
FRUCTOSE6YSS42VSEVIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
POLYSORBATE 806OZP39ZG8HIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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