Label: TRI-VITAMIN WITH FLUORIDE- vitamin a, ascorbic acid, vitamin d, and sodium fluoride solution/ drops
- NHRIC Code(s): 44946-1035-8
- Packager: Sancilio & Company Inc
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated March 6, 2018
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- 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.
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.
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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) since these may decrease effectiveness.
Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis.
This medical food product is formulated to be administered orally, under the 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. This product is a medical food and is not intended to be used as a drug or dietary supplement.
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.
SHAKE WELL BEFORE USING
- DIRECTIONS
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
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INGREDIENTS AND APPEARANCE
TRI-VITAMIN WITH FLUORIDE
vitamin a, ascorbic acid, vitamin d, and sodium fluoride solution/ dropsProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:44946-1035 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A 1500 [iU] in 1 mL Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 35 mg in 1 mL Vitamin D (UNII: 9VU1KI44GP) (Vitamin D - UNII:9VU1KI44GP) Vitamin D 400 [iU] in 1 mL Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Polysorbate 80 (UNII: 6OZP39ZG8H) Sodium hydroxide (UNII: 55X04QC32I) Propylene glycol (UNII: 6DC9Q167V3) Sucralose (UNII: 96K6UQ3ZD4) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:44946-1035-8 1 in 1 CARTON 1 50 mL in 1 BOTTLE, PLASTIC 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 flavor Labeler - Sancilio & Company Inc (176681257)
