TRI-VI-FLOR- multivitamin and fluoride supplement suspension/ drops 
Aytu Therapeutics, LLC

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Tri-Vi-Flor

Multivitamin and Fluoride Supplement

Supplement Facts
Serving Size 1 mL Dropperful Daily
Servings Per Container 50
% Daily Value
Amount Per 1 mLInfantsChildren Under Age 4 Years
Vitamin A (as palmitate) 1125 IU75%45%
Vitamin D3 (as cholecalciferol) 300 IU75%75%
L-methylfolate Calcium (as Metafolin®) 200 mcg162%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 1-866-416-9637

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.

Dosing Tips

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.

Shake well before use.

This product comes with a child-resistant cap. Refrigeration not required. After opening, store away from direct sunlight.

WARNING

As with medicines, keep out of the reach of children.

PRINCIPAL DISPLAY PANEL - Tri-Vi-Flor with 0.25 mg of Fluoride

23594-700-50

Tri-Vi-Flor

Essential Vitamins for Infants & Toddlers

FRUITY FLAVOR

MULTIVITAMIN AND FLUORIDE SUPPLEMENT

0.25 mg

NEW FORMULATION
NOT SUBSTITUTABLE

CONTAINS: METAFOLIN

1 2/3 FL OZ (50 mL)

Zylera Pharmaceuticals

Tri-Vi-Flor with 0.25 mg of Fluoride

TRI-VI-FLOR 
multivitamin and fluoride supplement suspension/ drops
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:23594-700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1125 [iU]  in 50 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL300 [iU]  in 50 mL
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID200 ug  in 50 mL
FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:23594-700-501 in 1 PACKAGE
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement09/01/2016
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
flavor
Labeler - Aytu Therapeutics, LLC (117244733)

Revised: 4/2019
Document Id: b47696cd-75b5-4824-8bec-e347d8b7f4a3
Set id: 40130338-ee51-42c9-babb-c4aab442d3f4
Version: 5
Effective Time: 20190408
 
Aytu Therapeutics, LLC