TRI-VI-FLOR- multivitamin and fluoride supplement suspension/ drops

Tri-Vi-Flor by

Drug Labeling and Warnings

Tri-Vi-Flor by is a Other medication manufactured, distributed, or labeled by Aytu Therapeutics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Tri-Vi-Flor

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 1-866-416-9637

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.

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.

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

INGREDIENTS AND APPEARANCE

TRI-VI-FLOR 
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 - Cerecor, Inc. (968799028)