LUDENT- sodium fluoride tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)

Available from:

Sancilio & Company Inc

Administration route:

ORAL

Therapeutic indications:

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 information

Authorization status:

Dietary Supplement

Summary of Product characteristics

LUDENT- SODIUM FLUORIDE TABLET, CHEWABLE
SANCILIO & COMPANY INC
----------
LUDENT FLUORIDE CHEWS
EACH 1.0 MG FLUORIDE TABLET CONTAINS:
*
Fluoride (as Sodium Fluoride)
1.0 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.
DES CRIPTION
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 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
®
EACH 1.0 MG FLUORIDE TABLET CONTAINS 1.0 MG FLUORIDE FROM
2.2 MG SODIUM FLUORIDE (NAF).
*
evaluation.
The numeric identifier on this product's labeling is an assigned
product code for use with pharmacy-
level, health-insurance and state level reimbursem