Multivitamin With Fluoride
FDA Label NDC 50090-0435

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Multivitamin With Fluoride (NDC 50090-0435). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, warning, directions, caution, other ingredients, storage, other, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Each Multivitamin with 0.5 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)

Each Multivitamin with 0.5 mg Fluoride Tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride (NaF).

0.5 mg

Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and "5" on the other.

Warning

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

USE AS DIRECTED BY YOUR PHYSICIAN.

Caution

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

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

Storage

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

Other

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

Product: 50090-0435

NDC: 50090-0435-1 100 TABLET, CHEWABLE in a BOTTLE, PLASTIC

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