The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Multivitamin With Fluoride (NDC 50090-0356). 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 warning, directions, description, caution, other ingredients, storage, other, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
USE AS DIRECTED BY YOUR PHYSICIAN.
Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and "3" on the other.
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.
Xylitol, microcrystalline cellulose, mannitol, talc, magnesium stearate, sucralose, natural fruit flavor, citric acid.
Store in a cool, dry place at room temperature 20° - 25°C (68° - 77°F) away from heat and sunlight. Store in original container.
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
Product: 50090-0356
NDC: 50090-0356-0 100 TABLET, CHEWABLE in a BOTTLE, PLASTIC
* Please review the disclaimer below.
