MULTI VITAMIN DROPS WITH FLUORIDE- vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol succinate, d-thiamine hydrochloride, riboflavin 5-phosphate sodium, cyanocobalamin, niacinamide, pyridoxine hydrochloride and sodium fluoride solution/ drops
Seton Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Multi-Vitamin Drops with Fluoride
0.25 mg

Supplemental Facts
Amount Per Serving	Percentage of U.S. Recommended Daily Allowance
* U.S. Recommended Daily Allowance has not been established.
Serving Size: 1.0 mL
Each 1.0 mL supplies:	Children 6 mos - 4 years old
Vitamin A (as Vitamin A Palmitate)	1500 IU	60%
Vitamin C (as Ascorbic Acid)	35 mg	88%
Vitamin D (as Cholecalciferol)	400 IU	100%
Vitamin E (as d-alpha-tocopheryl acid succinate)	5 IU	50%
Vitamin B1 (as Thiamine HCI)	0.5 mg	71%
Vitamin B2 (as Riboflavin Phosphate Sodium)	0.6 mg	75%
Vitamin B12 (as Cyanocobalamin)	2 mcg	67%
Niacin (as Niacinamide)	8 mg	89%
Vitamin B6 (as Pyridoxine HCl)	0.4 mg	57%
Fluoride (as Sodium Fluoride)	0.25 mg	*

DOSAGE AND ADMINISTRATION:

See package insert for complete prescribing and dosing information.

Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. This product does not contain Folic Acid.

Other Ingredients: Caramel color, cherry flavor, ferrous sulfate, oil of orange, glycerin, methylparaben, polysorbate 80, purified water, sodium benzoate and sodium hydroxide.

Fluoride Ion Level in Drinking Water (ppm)*
Age	<0.3 ppm	0.3-0.6 ppm	>0.6 ppm
* 1.0 ppm = 1 mg/liter † 2.2 mg sodium fluoride contains 1 mg fluoride ion.
Birth - 6 months	None	None	None
6 mos - 3 years	0.25 mg (1 mL) / day†	None	None
3 - 6 years	0.50 mg (2 mL) / day	0.25 mg (1 mL) / day	None

HOW SUPPLIED

Multi-Vitamin and Fluoride 0.25 mg drops is available in 50 mL bottles with accompanying calibrated dropper.

RECOMMENDED STORAGE

Store at controlled room temperature 15°-25°C (between 59°F and 77°F). Excursions Permitted. After opening store away from direct light. Close tightly after each use. Occasional deepening of color has no significant effect on vitamin potency. REFRIGERATION IS NOT REQUIRED. SHAKE WELL.

Manufactured for:
Seton Pharmaceuticals, LLC
Manasquan, NJ 08736
1-800-510-3401

Rev. 02/14

Made in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.25 mg label

NDC 13925-167-50

Multi-Vitamin
Drops

With Fluoride

0.25 mg

MULTI-VITAMIN
AND FLUORIDE
SUPPLEMENT DROPS

Rx Only

1.69 FL. OZ. (50 mL)

SETON
PHARMACEUTICALS

MULTI VITAMIN DROPS WITH FLUORIDE
vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol succinate, d-thiamine hydrochloride, riboflavin 5-phosphate sodium, cyanocobalamin, niacinamide, pyridoxine hydrochloride and sodium fluoride solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:13925-167
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	1500 [iU] in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	35 mg in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU] in 1 mL
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL SUCCINATE, D-	5 [iU] in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	0.5 mg in 1 mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E)	FLAVIN MONONUCLEOTIDE	0.6 mg in 1 mL
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	2 ug in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	8 mg in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	0.4 mg in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FERROUS SULFATE (UNII: 39R4TAN1VT)
ORANGE OIL (UNII: AKN3KSD11B)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	BROWN (caramel)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13925-167-50	50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/18/2014	09/30/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/18/2014	09/30/2017

Labeler - Seton Pharmaceuticals (828898002)

Name	Address	ID/FEI	Business Operations
Establishment
Sonar Products		104283945	manufacture(13925-167)

Revised: 8/2016

Document Id: 5705cc02-e7ea-4f82-beb8-1cff60dbcee0

Set id: 32130bf3-cb1c-4c45-95f9-48b47fa2462c

Version: 5

Effective Time: 20160811

Seton Pharmaceuticals

Multi-Vitamin Drops with Fluoride 0.25 mg

DOSAGE AND ADMINISTRATION:

HOW SUPPLIED

RECOMMENDED STORAGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.25 mg label

Multi-Vitamin Drops with Fluoride
0.25 mg