Multivitamin with Fluoride description, usages, side effects, indications, overdosage, supplying and lots more!

Multivitamin with Fluoride

PureTek Corporation

  • 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
Prescribing Information

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

MULTIVITAMIN WITH FLUORIDE vitamin A, ascorbic acid, sodium ascorbate, cholecalciferol, alpha-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable

Each Fluoride Chewable Tablet Contains:

Nutrition Facts



Amount per tablet        0.25 mg         %DV Adults and Children 4 years or More







6

12






Multivitamin with 0.25 mg Fluoride Chewable Tablets


12

CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Multivitamin with 0.25 mg Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

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INDICATIONS AND USAGE





Multivitamin with 0.25 mg Fluoride Chewable Tablets


Multivitamin with 0.25 mg Fluoride Chewable Tablets612



Multivitamin with 0.25 mg Fluoride Chewable Tablets




WARNING


Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.




PRECAUTIONS


Multivitamin with 0.25 mg Fluoride Chewable Tablets

Multivitamin with 0.25 mg Fluoride Chewable Tablets:








ADVERSE REACTIONS


DOSAGE AND ADMINISTRATION



HOW SUPPLIED

Multivitamin Chewable tablets containing 0.25 mg fluoride are purple-colored, grape flavor, un-scored, round debossed "107" tablets are available on prescription only in bottles of 100 tablets. NDC: 59088-107-59.



STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Base Label

Base Label

Inside Label

Inside LabelEnter section text here

Outside label

Outside labelEnter section text here

Multivitamin with Fluoride

Sodium Fluoride TABLET, CHEWABLE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:59088-107
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.25 mg
VITAMIN A 2500 [iU]
ASCORBIC ACID ASCORBIC ACID 24 mg
sodium ascorbate ASCORBIC ACID 36 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- 15 [iU]
THIAMINE MONONITRATE THIAMINE ION 1.05 mg
RIBOFLAVIN RIBOFLAVIN 1.2 mg
NIACINAMIDE 13.5 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 1.05 mg
FOLIC ACID FOLIC ACID 300 ug
Cyanocobalamin CYANOCOBALAMIN 4.5 ug

Inactive Ingredients

Ingredient Name Strength
SUCROSE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
FD&C BLUE NO. 1
MAGNESIUM STEARATE
cellulose, microcrystalline
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
purple (Dark purple) 13 mm 107 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59088-107-59 100 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-01


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