Skip to Content

Multi Vitamin Fluoride Drops

Generic Name: vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol succinate, d-thiamine hydrochloride, riboflavin 5-phosphate sodium, cyanocobalamin, niacinamide, pyridoxine hydrochloride and sodium fluoride
Dosage Form: oral drops

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.

Supplemental Facts
*
U.S. Recommended Daily Allowance has not been established.
Serving Size: 1.0 mL
Amount Per Serving Percentage of U.S.
Recommended
Daily Allowance
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)*
*
1.0 ppm = 1 mg/liter
2.2 mg sodium fluoride contains 1 mg fluoride ion.
Age <0.3 ppm 0.3-0.6 ppm >0.6 ppm
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 LABEL Item Code (Source) NDC:13925-167
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A PALMITATE (VITAMIN A) VITAMIN A 1500 [iU]  in 1 mL
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 35 mg  in 1 mL
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]  in 1 mL
.ALPHA.-TOCOPHEROL SUCCINATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL SUCCINATE, D- 5 [iU]  in 1 mL
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE 0.5 mg  in 1 mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM (FLAVIN MONONUCLEOTIDE) FLAVIN MONONUCLEOTIDE 0.6 mg  in 1 mL
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 2 ug  in 1 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 8 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 0.4 mg  in 1 mL
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
FERROUS SULFATE  
ORANGE OIL  
GLYCERIN  
METHYLPARABEN  
POLYSORBATE 80  
WATER  
SODIUM BENZOATE  
SODIUM HYDROXIDE  
Product Characteristics
Color BROWN (caramel) Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:13925-167-50 50 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/18/2014 09/30/2017
Labeler - Seton Pharmaceuticals (828898002)
Establishment
Name Address ID/FEI Operations
Sonar Products 104283945 manufacture(13925-167)
Revised: 08/2016
 
Seton Pharmaceuticals



Hide