MULTIVITAMIN DROPS WITH FLUORIDE

Manufacturer
Neos Therapeutics, LP
Effective date
2025-04-16
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:51:36

Label at a glance#

ProductMULTIVITAMIN DROPS WITH FLUORIDE
Active ingredientCHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, 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 formul...

Label contents#

Full prescribing information#

MULTIVITAMIN DROPS WITH FLUORIDE

STATEMENT OF IDENTITY SECTION

(Multivitamin with 0.25 mg of Fluoride)

Fruity Flavor

Not Substitutable

Health Claim

HEALTH CLAIM SECTION

Multivitamin and Fluoride Supplement Drops

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 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 (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

Contains: Arcofolin®

MULTIVITAMIN DROPS WITH FLUORIDE are specially designed to help meet the nutritional needs of your growing infant or toddler.

  • MULTIVITAMIN DROPS WITH FLUORIDE 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 MULTIVITAMIN DROPS WITH FLUORIDE 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

WARNING: As with all medicines, keep out of reach of children.

Dispense under a physician’s order

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

CAS# 151533-22-1

Distributed by:
Neos Therapeutics
Denver, CO 80237
1-855-298-8246
www.neostx.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - MULTIVITAMIN DROPS WITH 0.25 MG OF FLUORIDE

62542-805-50

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)

Neos Therapeutics

Bottle Label
Bottle Label
Carton Label
Carton Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
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
62542-805-50MULTIVITAMIN DROPS WITH FLUORIDE1 in 1 CARTONSUSPENSION/ DROPS12
62542-805-50MULTIVITAMIN DROPS WITH FLUORIDE50 mL in 1 BOTTLESUSPENSION/ DROPS502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62542-805MULTIVITAMIN DROPS WITH FLUORIDE (VITAMIN D (AS CHOLECALCIFEROL), VITAMIN E (AS D-ALPHA-TOCOPHERYL ACETATE), NIACIN (AS NIACINAMIDE), VITAMIN B6 (AS PYRIDOXINE HCL), FOLATE (AS ARCOFOLIN), FLUORIDE (AS SODIUM FLUORIDE)) SUSPENSION/ DROPS [NEOS THERAPEUTICS, LP]22 package rows20250421_a13c1cd6-0cdc-48e0-a148-752da6f002e8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62542-805-50ML - Milliliter62542-80541f89e61-60a9-4670-b1c5-e309d1023b2912025-05-14

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
62542-80562542-805-50

Ingredients#

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

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

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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