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
0.5 mg

Supplemental Facts
*
Daily Value not established
Serving Size: 1.0 mL
Amount Per ServingPercentage of U.S.
Recommended
Daily Allowance
Each 1.0 mL supplies:Children 6 mos -
4 years old
Vitamin A (as Vitamin A Palmitate)1500 IU60%
Vitamin C (as Ascorbic Acid)35 mg88%
Vitamin D (as Cholecalciferol)400 IU100%
Vitamin E (as d-alpha-tocopheryl acid succinate)5 IU50%
Vitamin B1 (as Thiamine HCl)0.5 mg71%
Vitamin B2 (as Riboflavin Phosphate Sodium)0.6 mg75%
Vitamin B12 (as Cyanocobalamin)2 mcg67%
Niacin (as Niacinamide)8 mg89%
Vitamin B6 (as Pyridoxine HCl)0.4 mg57%
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, oil of orange, ferrous sulfate, glycerin, methylparaben, polysorbate 80, purified water, sodium benzoate and sodium hydroxide.

Fluoride Ion Level in Drinking Water (ppm)*
*
1.0 ppm = 1 mg/liter
2.2 mg sodium fluoride contains 1 mg fluoride ion.
Age<0.3 ppm0.3-0.6 ppm>0.6 ppm
Birth - 6 monthsNoneNoneNone
6 mos - 3 years0.25 mg (0.5 mL) / dayNoneNone
3 - 6 years0.50 mg (1 mL)/day0.25 mg (0.5 mL)/dayNone

HOW SUPPLIED

Multi-Vitamin and Flouride 0.5 mg drops is available in 50 mL bottles with accompanying calibrated dropper.

a0b3108e-figure-03

RECOMMENDED STORAGE

Store at 20º to 25ºC (68º to 77ºF), excursions permitted (between 15ºC and 30ºC (betwen 59ºF and 86ºF). 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 - 0.5 mg label

NDC 13925-168-50

Multi-Vitamin
Drops

With Fluoride

0.5 mg

MULTI-VITAMIN
AND FLUORIDE
SUPPLEMENT DROPS

Rx Only

1.69 FL. OZ. (50 mL)

SETON
PHARMACEUTICALS

container label
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:13925-168
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (RETINOL - UNII:G2SH0XKK91) RETINOL1500 [iU]  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID35 mg  in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [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) THIAMINE0.5 mg  in 1 mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E) FLAVIN MONONUCLEOTIDE0.6 mg  in 1 mL
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN2 ug  in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE8 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE0.4 mg  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ORANGE OIL (UNII: AKN3KSD11B)  
FERROUS SULFATE (UNII: 39R4TAN1VT)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorBROWN (caramel) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13925-168-5050 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/18/201407/21/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/18/201407/21/2016
Labeler - Seton Pharmaceuticals (828898002)
Registrant - Seton Pharmaceuticals (828898002)

Revised: 12/2017
 
Seton Pharmaceuticals