POLY-VI-FLOR- multivitamin and fluoride supplement tablet, chewable

Poly-Vi-Flor by

Drug Labeling and Warnings

Poly-Vi-Flor by is a Other medication manufactured, distributed, or labeled by Cerecor, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Poly-Vi-Flor

(Multivitamin with .5 mg of Fluoride and 10 mg Iron) Chewable Tablet

HEALTH CLAIM

Multivitamin and Fluoride Supplement

Supplement Facts
Serving Size 1 Tablet
Amount Per Tablet		U.S. Recommended Daily Allowance (%) Adults and Children 4 or More Years of Age
Vitamin A	2000 IU	40%
Vitamin C	60 mg	100%
Vitamin D	400 IU	100%
Vitamin E	15 IU	50%
Thiamin	1 mg	67%
Riboflavin	1.2 mg	71%
Niacin	10 mg	50%
Vitamin B6	1 mg	53%
L-methylfolate Calcium (as Metafolin®)	200 mcg	*
Vitamin B12	4.5 mcg	75%
Iron	10 mg	*
Fluoride	0.5 mg	*

*U.S. Recommended Daily Allowance has not been established

INGREDIENTS: SUCROSE, SORBITOL, FRUCTOSE, CITRIC ACID, BEET ROOT JUICE, NAT. RASPBERRY FLV., GRAPE FLAVOR, STEARIC ACID, CARRAGEENAN, CHERRY FLAVOR, MAGNESIUM STEARATE, SUCRALOSE

WARNINGS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately

DOSAGE & ADMINISTRATION

Distributed by:
Zylera Pharmaceuticals
Research Triangle Park, NC 27713

Should be chewed.

SAFE HANDLING WARNING

This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

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

PRINCIPAL DISPLAY PANEL - Multivitamin with .5 mg of Fluoride and 10 mg Iron

23594-100-30

Poly-Vi-Flor

(Multivitamin with .5 mg of Fluoride and 10 mg Iron) Chewable Tablet

MULTIVITAMIN & FLUORIDE SUPPLEMENT

BERRY FLAVOR

0.5 mg with Iron

30 Tablets

CONTAINS: METAFOLIN

Zylera Pharmaceuticals

INGREDIENTS AND APPEARANCE

POLY-VI-FLOR 
multivitamin and fluoride supplement tablet, chewable

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:23594-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	2000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	60 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	15 [iU]
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.2 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	10 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	1 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	200 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	4.5 ug
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	10 mg
FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
SORBITOL (UNII: 506T60A25R)
FRUCTOSE (UNII: 6YSS42VSEV)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARRAGEENAN (UNII: 5C69YCD2YJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:23594-100-30	1 in 1 PACKAGE
1		30 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
shape
size (solid drugs)	10 mm
scoring	1
flavor

Labeler - Cerecor, Inc. (968799028)