Label: TRI-VI-FLOR- multivitamin and fluoride supplement suspension/ drops
- NHRIC Code(s): 23594-800-50
- Packager: Aytu Therapeutics, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated April 8, 2019
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- Official Label (Printer Friendly)
- Tri-Vi-Flor
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HEALTH CLAIM
Multivitamin and Fluoride Supplement
Supplement Facts Serving Size 1 mL Dropperful Daily
Servings Per Container 50% Daily Value Amount Per 1 mL Infants Children Under Age 4 Years Vitamin A (as palmitate) 1125 IU 75% 45% Vitamin D3 (as cholecalciferol) 300 IU 75% 75% L-methylfolate Calcium (as Metafolin®) 200 mcg 162% 81% Fluoride (as sodium fluoride) 0.50 mg * * *U.S. Recommended Daily Allowance has not been established
OTHER INGREDIENTS: Sucrose, water, citric acid, sodium benzoate, potassium sorbate.
Distributed by: Zylera Pharmaceuticals
Research Triangle Park, NC 27713U.S. Patent No. 5,997,915 • U.S. Patent No. 6,254,904
U.S. Patent No. 6,011,040 • U.S. Patent No. 6,441,168Metafolin® is a registered trademark of Merck KGaA, Darmstadt, Germany *CAS# 151533-22-1
QUESTIONS OR COMMENTS? Please call Zylera Medical Affairs at 1-866-416-9637
- How to Use the Enclosed Dropper
- SAFE HANDLING WARNING
- WARNING
- PRINCIPAL DISPLAY PANEL - Tri-Vi-Flor with 0.5 mg of Fluoride
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INGREDIENTS AND APPEARANCE
TRI-VI-FLOR
multivitamin and fluoride supplement suspension/ dropsProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:23594-800 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 1125 [iU] in 50 mL CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 300 [iU] in 50 mL LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 200 ug in 50 mL FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg in 50 mL Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:23594-800-50 1 in 1 PACKAGE 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 09/01/2016 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color flavor Labeler - Aytu Therapeutics, LLC (117244733)