FDA.reportPublic FDA data

Multivitamin with Fluoride Chewable Tablets

Manufacturer
A-S Medication Solutions
Effective date
2017-09-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 20:24:30

Label at a glance#

ProductMultivitamin with fluoride
Active ingredient.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, SODIUM FLUORIDE, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, THIAMINE, VITAMIN A, VITAMIN D
Label structure10 sections

Dosage and administration

USE AS DIRECTED BY YOUR PHYSICIAN.

Storage and handling

Store in a cool, dry place at room temperature 20° - 25°C (68° - 77°F) away from heat and sunlight. Store in original container.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Each Multivitamin with 1.0 mg Fluoride Tablet Contains:
Vitamin A (as Acetate)2500 IU
Vitamin C60 mg
Vitamin D400 IU
Vitamin E15 IU
Thiamine1.05 mg
Riboflavin1.2 mg
Niacin13.5 mg
Vitamin B61.05 mg
Folate (as Folic Acid)0.3 mg
Vitamin B124.5 mcg
Fluoride (as Sodium Fluoride)* 1.0 mg

* Each Multivitamin with 1.0 mg Fluoride Tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride (NaF).

WARNING

WARNINGS SECTION

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOKING.

DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING

Directions

DOSAGE & ADMINISTRATION SECTION

USE AS DIRECTED BY YOUR PHYSICIAN.

Description

DESCRIPTION SECTION

Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and "3" on the other.

Caution

PRECAUTIONS SECTION

Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

Other Ingredients

SPL UNCLASSIFIED SECTION

Xylitol, microcrystalline cellulose, mannitol, talc, magnesium stearate, sucralose, natural fruit flavor, citric acid.

Storage

STORAGE AND HANDLING SECTION

Store in a cool, dry place at room temperature 20° - 25°C (68° - 77°F) away from heat and sunlight. Store in original container.

SPL UNCLASSIFIED SECTION

This medical food product is formulated to be administered orally, under the ongoing supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation.

The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

Manufactured by: Sancilio & Co., Inc. Riviera Beach, FL 33404 USA

rev. 11/18/11

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0356

NDC: 50090-0356-0 100 TABLET, CHEWABLE in a BOTTLE, PLASTIC

.Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, and Vitamin D

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128238400099876541299lbl500900356.jpg

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
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0356-02020-01-31C16284748780-19d75b9d0-e40d-f424-e053-dadaa90a57ceMultivitamin with Fluoride Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0356-0Multivitamin with fluoride100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0356MULTIVITAMIN WITH FLUORIDE (.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, SODIUM FLUORIDE, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, THIAMINE, VITAMIN A, AND VITAMIN D) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20170927_80a1ca72-91ee-43aa-b918-a508ce632cf8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0356-0EA - Each50090-035683329852-578d-4af1-84b8-56720b810d4f12018-09-05
44946-1025-1EA - Each44946-1025c8b4dcfc-450f-4947-9fa8-d722aaf9870e12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-035650090-0356-0
44946-1025

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
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8ACTIM
ASCORBIC ACIDPQ6CK8PD0RACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
FOLIC ACID935E97BOY8ACTIB
NIACIN2679MF687AACTIB
PYRIDOXINEKV2JZ1BI6ZACTIB
RIBOFLAVINTLM2976OFRACTIB
THIAMINEX66NSO3N35ACTIB
VITAMIN A81G40H8B0TACTIB
VITAMIN D9VU1KI44GPACTIB
XylitolVCQ006KQ1EIACT
microcrystalline celluloseOP1R32D61UIACT
Mannitol3OWL53L36AIACT
Talc7SEV7J4R1UIACT
Magnesium stearate70097M6I30IACT
Sucralose96K6UQ3ZD4IACT
Anhydrous Citric acidXF417D3PSLIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aa236fb9-1c97-4388-a272-936ad70c14a280a1ca72-91ee-43aa-b918-a508ce632cf82017-09-27WarningsExact identifier
spl id: aa236fb9-1c97-4388-a272-936ad70c14a2
spl set id: 80a1ca72-91ee-43aa-b918-a508ce632cf8

Reported adverse events (FAERS/openFDA)#

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