Ludent - Fluoride Chews 1.0 mg

Brand IP Statement(s) re: (c), (TM), (SM)

SCI Developing Good Science into Great Medicine

Precautions re: All Other

Rx Only

Formula re: Contains

Sodium fluoride chewable tablets

Formulation re: Does NOT Contain

No dyes, artificial flavors or sugar Saccharin and gluten free

Formula re: Contains

Contains Xylitol

Formulation re: Other

Made in U.S.A.

Formula re: Contains

Each 1.0 mg fluoride tablet contains 1.0 mg fluoride from 2.2 mg sodium fluoride (NaF).

Precautions re: Children

Warning: Keep this and all medications out of the reach of children. If overdosage is suspected, seek professional assistane 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.

Precautions re: All Other

Do not use if foil seal under cap is broken or missing

Suggested/Recommended/Usage/Directions

Directions: Use as directed by your physician.

Formulation re: Other

Description: White to off-white, orange flavor, round-shaped chewable tablet debossed "SCI" on one side and "4" on the other.

Precautions re: Allergies

Caution: Do not use this product if you are allergic to any of the ingredients.

Precautions re: All Other

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).

Precautions re: All Other

Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

Storage

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

Formulation re: 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.

General Statements: All Other Content

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.

General Statements: All Other Content

44946-1010-3