Label: LUDENT- sodium fluoride tablet, chewable
- NHRIC Code(s): 50090-3546(NDC:44946-1010), 50090-3546-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 44946-1010
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated August 30, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- STATEMENT OF IDENTITY
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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
- Description
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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
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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.
- HEALTH CLAIM
- Sodium Fluoride
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INGREDIENTS AND APPEARANCE
LUDENT
sodium fluoride tablet, chewableProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:50090-3546(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) FLUORIDE ION 1 mg Inactive Ingredients Ingredient Name Strength Xylitol (UNII: VCQ006KQ1E) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Malic Acid (UNII: 817L1N4CKP) Magnesium Stearate (UNII: 70097M6I30) Talc (UNII: 7SEV7J4R1U) Anhydrous Citric Acid (UNII: XF417D3PSL) Sucralose (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:50090-3546-0 24 in 1 BOX 1 120 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Dietary Supplement 12/20/2011 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring shape size (solid drugs) 13 mm imprint flavor Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-3546)
