Multi Vitamin Drops with Fluoride description, usages, side effects, indications, overdosage, supplying and lots more!

Multi Vitamin Drops with Fluoride

Seton Pharmaceuticals

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Multi-Vitamin DropsWith Fluoride 0.5 mg

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Supplemental Facts
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 HCl) 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 Daily Value not established

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
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 (0.5 mL) / day2.2 mg sodium fluoride contains 1 mg fluoride ion. None None
3 - 6 years 0.50 mg (1 mL)/day 0.25 mg (0.5 mL)/day None

HOW SUPPLIED

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

HOW SUPPLIED

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.5 mg 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 Type Human prescription drug label Item Code (Source) NDC:13925-168
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
VITAMIN A PALMITATE 1500 [iU]
ASCORBIC ACID ASCORBIC ACID 35 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL SUCCINATE, D- 5 [iU]
THIAMINE HYDROCHLORIDE THIAMINE 0.5 mg
RIBOFLAVIN 5'-PHOSPHATE SODIUM RIBOFLAVIN 0.6 mg
Cyanocobalamin CYANOCOBALAMIN 2 ug
NIACINAMIDE 8 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 0.4 mg
SODIUM FLUORIDE FLUORIDE ION 0.5 mg

Inactive Ingredients

Ingredient Name Strength
ORANGE OIL
FERROUS SULFATE
GLYCERIN
METHYLPARABEN
polysorbate 80
water
SODIUM BENZOATE
SODIUM HYDROXIDE

Product Characteristics

Color
BROWN (caramel)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13925-168-50 50 in 1 BOTTLE, DROPPER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2014-04-18


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