FDA.reportPublic FDA data

Multivitamin-025-tablets

Manufacturer
Neos Therapeutics, LP
Effective date
2023-07-06
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:51

Label at a glance#

ProductMultivitamin with 0.25 mg Fluoride
Active ingredientVITAMIN A ACETATE, SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, 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.

Label contents#

Full prescribing information#

Multivitamin with Fluoride

STATEMENT OF IDENTITY SECTION

(Multivitamin with 0.25 mg of Fluoride) Chewable Tablet

Health Claim

HEALTH CLAIM SECTION

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 mcg 67%
Vitamin C (as sodium ascorbate) 60 mg 67%
Vitamin D (as cholecalciferol) 10 mcg 50%
Vitamin E (as d-alpha-tocopherol) 10 mg 67%
Thiamin (as thiamin mononitrate 1 mg 83%
Riboflavin 1.2 mg 92%
Niacin (as niacinamide) 10 mg 63%
Vitamin B6 (as pyridoxine HCl) 1 mg 59%
Folate (as Metafolin®) 200 mcg DFE 50%
Vitamin B12 (as cyanocobalamin) 4.5 mcg 188%
Fluoride (as sodium fluoride) 0.25 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.


Warnings

WARNINGS SECTION

Allergen Warning: Contains fish gelatin and soy oil.

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.

Safe Handling Warning

SAFE HANDLING WARNING SECTION

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

Distributed by:
Neos Therapeutics
2940 N. Highway 360
Grand Prairie, TX 75050
www.neostx.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62542-200-30

Multivitamin with Fluoride

(Multivitamin with 0.25 mg of Fluoride) Chewable Tablet

BERRY FLAVOR

0.25 mg

30 Tablets

CONTAINS:METAFOLIN®

NEOS THERAPEUTICS

Multivitamin with 0.25 mg of Fluoride
Multivitamin with 0.25 mg of Fluoride

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
62542-200-30Multivitamin with 0.25 mg Fluoride30 in 1 BOTTLETABLET, CHEWABLE302
62542-200-30Multivitamin with 0.25 mg Fluoride1 in 1 PACKAGETABLET, CHEWABLE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62542-200MULTIVITAMIN WITH 0.25 MG FLUORIDE (MULTIVITAMIN WITH FLUORIDE) TABLET, CHEWABLE [NEOS THERAPEUTICS, LP]22 package rows20230708_e93fe568-0e36-429c-9fd9-458918be36bd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62542-200-30EA - Each62542-20049571a2a-6a3e-439e-b34e-5326674583de12023-08-08

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62542-20062542-200-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A ACETATE3LE3D9D6OYACTIM
SODIUM ASCORBATES033EH8359ACTIM
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL, D-N9PR3490H9ACTIB
THIAMINE MONONITRATE8K0I04919XACTIR
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
CYANOCOBALAMINP6YC3EG204ACTIB
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.