Ludent - Fluoride Chews 0.5 mg

Basic Information

Product Label

Product label for Ludent - Fluoride Chews 0.5 mg
Full Name: Ludent - Fluoride Chews 0.5 mg
Brand: Sancilio & Company none
Product Type: Mineral
Physical State: Tablet or Pill
UPC/SKU: 3 44946 10099 9
Product Version Code: REV 03/11/2016

Contact Information

Manufactured by

Name: Sancilio & Company, Inc.
Address:3874 Fiscal Court, Riviera Beach, FL, 33404
Phone: (800) 724-8711
Types: Manufacturer

Product Details

Net Contents

1000 Tablet(s)(1000 Tablet(s))

Serving Sizes

Unit:Tablet(s)
Quantity:1 - 1
Daily Servings:1 -

Target Groups

Children 4 or More Years of AgeAdult (18 - 50 Years)Gluten FreeSugar Free

Servings Per Container

1000

Ingredients & Nutrition

Fluoride

mineral
Forms:
  • Sodium Fluoride
Amount: 0.5 mg
Serving Size: 1 Tablet(s)
Adults and children 4 or more years of age: % (Daily Value not established)

Group: Flouride

UNII Code: Q80VPU408O

Citric Acid

non-nutrient/non-botanical

Group: Citric Acid

Group: Magnesium stearate

Malic Acid

non-nutrient/non-botanical

Group: Malic Acid

MCC

other

Group: Cellulose

Also known as: Microcrystalline Cellulose

Group: Cellulose

Group: Flavor

Sucralose

non-nutrient/non-botanical

Group: Sucralose

UNII Code: 96K6UQ3ZD4

Talc

other

Group: Magnesium Silicate

Xylitol

non-nutrient/non-botanical

Group: Xylitol

Product Statements

General Statements: All Other Content

44946-1009-9

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

FDA Statement of Identity

Dietary Supplement

Precautions re: All Other

Dispense under a physician's order

Precautions re: Children

Warning: Keep this product out of the reach of children.

Precautions re: All Other

If overdosage is suspected, seek professional assistance or contact a poison control center immediately 1-800-222-1222. Tablet should be chewed.

Suggested/Recommended/Usage/Directions

Tablet should be chewed.

Precautions re: Children

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 "1007" on the other.

Precautions re: Allergies

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

Precautions re: Pregnant or Nursing or Prescription Medications

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

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.

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.

Precautions re: All Other

The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.

Seals/Symbols

Made in the USA

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

SCI Sancilio & Company, Inc. Developing Good Science into Great Medicine

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