Label: LUDENT- sodium fluoride tablet, chewable
- NDC Code(s): 44946-1010-3
- Packager: Sancilio & Company Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated December 21, 2011
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- SPL UNCLASSIFIED 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 MISSINGClose
USE AS DIRECTED BY YOUR PHYSICIAN.Close
White to off-white, orange flavor, round-shaped chewable tablet debossed "SCI" on one side and "4" on the other.
See inside panel for additional informationClose
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.Close
- Other Ingredients
Xylitol, microcrystalline cellulose, malic acid, magnesium stearate, talc, citric acid, natural orange flavor, sucralose.Close
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.Close
- SPL UNCLASSIFIED SECTION
Manufactured by: Sancilio & Co., Inc.
Riviera Beach, FL 33404 USA
- PRINCIPAL DISPLAY PANEL - 1.0 mg Bottle Label
Developing Good Science into Great Medicine
Sodium Fluoride Chewable Tablets
NO DYES, ARTIFICIAL FLAVORS OR SUGAR
SACCHARIN AND GLUTEN FREE
Made in U.S.A.
- INGREDIENTS AND APPEARANCE
sodium fluoride tablet, chewable
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44946-1010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 1 mg Inactive Ingredients Ingredient Name Strength Xylitol (UNII: VCQ006KQ1E) Cellulose, Microcrystalline (UNII: OP1R32D61U) Malic Acid (UNII: 817L1N4CKP) Magnesium Stearate (UNII: 70097M6I30) Talc (UNII: 7SEV7J4R1U) Anhydrous Citric Acid (UNII: XF417D3PSL) Sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color WHITE (White to off white) Score score with uneven pieces Shape ROUND Size 13mm Flavor ORANGE Imprint Code SCI;4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44946-1010-3 24 in 1 BOX 1 120 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/20/2011 Labeler - Sancilio & Company Inc (176681257)