Ludent description, usages, side effects, indications, overdosage, supplying and lots more!

Ludent

Sancilio & Company Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Ludent Fluoride Chews

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Each 0.25 mg Fluoride Tablet Contains:

Fluoride (as Sodium Fluoride) Each 0.25 mg Fluoride Tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride (NaF). 0.25 mg

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.

Description

White to off-white, orange flavor, round-shaped chewable tablet debossed "SCI" on one side and "6" on the other.

See inside panel for additional information

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, malic acid, magnesium stearate, talc, citric acid, natural orange flavor, sucralose.

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.

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. 12/02/11

PRINCIPAL DISPLAY PANEL - .25 mg Bottle Label

SCI
Sancilio &
Company, Inc.

Developing Good Science into Great Medicine

44946-1008-3
Rx Only

Ludent®-Fluoride
Chews

Sodium Fluoride Chewable Tablets

NO DYES, ARTIFICIAL FLAVORS OR SUGAR
SACCHARIN AND GLUTEN FREE
CONTAINS XYLITOL

0.25
mg*

120 tablets

Made in U.S.A.

PRINCIPAL DISPLAY PANEL - .25 mg Bottle Label

Ludent

Sodium Fluoride TABLET, CHEWABLE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:44946-1008
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.25 mg

Inactive Ingredients

Ingredient Name Strength
Xylitol
cellulose, microcrystalline
Malic Acid
MAGNESIUM STEARATE
talc
ANHYDROUS CITRIC ACID
Sucralose

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to off white) 11 mm SCI;6 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 NDC:44946-1008-3 24 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-12-20


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