Label: TRI-VI-FLOR- multivitamin and fluoride supplement suspension/ drops
- NDC Code(s): 23594-700-50
- Packager: Zylera Pharmaceuticals, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated December 6, 2018
If you are a consumer or patient please visit this version.
- 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) 0.25 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 27713
U.S. Patent No. 5,997,915 • U.S. Patent No. 6,254,904
U.S. Patent No. 6,011,040 • U.S. Patent No. 6,441,168
Metafolin® is a registered trademark of Merck KGaA, Darmstadt, Germany *CAS# 151533-22-1
QUESTIONS OR COMMENTS? Please call Zylera Medical Affairs at 1-866-416-9637Close
- How to Use the Enclosed Dropper
Fill the dropper to the 1 mL line to provide the full daily dosage. Use full dosage, regardless of age or weight, unless your child's doctor recommends a different dosage. Dispense with a single squeeze of the dropper bulb. It is normal for a small amount to remain in the tip.
Drops may be given by dispensing directly into the mouth. Drops may also be mixed with formula, fruit juice, cereal or other foods to increase your child's acceptance.
- SAFE HANDLING WARNING
Shake well before use.
This product comes with a child-resistant cap. Refrigeration not required. After opening, store away from direct sunlight.Close
As with medicines, keep out of the reach of children.Close
- PRINCIPAL DISPLAY PANEL - Tri-Vi-Flor with 0.25 mg of Fluoride
Essential Vitamins for Infants & Toddlers
MULTIVITAMIN AND FLUORIDE SUPPLEMENT
1 2/3 FL OZ (50 mL)
- INGREDIENTS AND APPEARANCE
multivitamin and fluoride supplement suspension/ drops
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:23594-700 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 0.25 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:23594-700-50 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 - Zylera Pharmaceuticals, LLC (032546121)