SODIUM FLUORIDE description, usages, side effects, indications, overdosage, supplying and lots more!

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SODIUM FLUORIDE

KIRKMAN GROUP, INC.

Sodium Fluoride Chewable Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

SODIUM FLUORIDE DESCRIPTION

Contains: 2.21 mg sodium fluoride equivalent to 1 mg fluoride ion

Inactive Ingredients: lactose, cherry flavor, saccharin sodium, magnesium stearate

WARNINGS

Caution: Federal (U.S.A.) law prohibits dispensing without a prescription.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Directions: One tablet per day, chewed or partially dissolved in mouth before swallowing, preferably at night after brushing teeth.

DOSAGE & ADMINISTRATION

Precaution: Recommended dosage on chart below should not be exceeded as prolonged overdose may result in dental fluorosis.

Daily Pediatric Dose:
Fluoride Content of
Drinking Water:
Birth to
6 mos.
6 mos. to
Age 3
Age 3
to 6
Age 6
to 16
Less than 0.3 ppm 0 1/4 tablet 1/2 tablet 1 tablets
0.3 to 0.6 ppm 0 0 1/4 tablet 1/2 tablet
Greater than 0.6 ppm 0 0 0 0

HOW SUPPLIED

Sodium Fluoride Chewable Tablets is supplied in tablets containing 2.21 mg sodium fluoride equivalent to 1 mg fluoride ion

NDC Number Size
58223-679-01 100 tablets
58223-679-04 1000 tablets
58223-679-09 5000 tablets
58223-679-70 70 tablets

STORAGE AND HANDLING

Dispense in light resistant, tight container as defined in the USP.

Keep bottle tightly closed.

Manufactured for: Kirkman Laboratories, Inc., Lake Oswego, OR 79035

FL035 

PRINCIPAL DISPLAY PANEL

KIRKMAN LABORATORIES, INC.

SODIUM FLUORIDE TABLETS

Dye-free!

Cherry Flavored

Chewable Sodium Fluoride Tablets USP

CAUTION: Federal law prohibits dispensing without prescription

A product of
KIRKMAN LABORATORIES, INC.
Lake Oswego, OR 97035

2.21 mg NaF = 1 mg Fluoride Ion

100 Tablets

NDC 58223-679-01

Each tablet contains 2.21 mg of Sodium Fluoride equivalent to 1 mg of the fluoride ion.

INGREDIENTS: Sodium Fluoride USP, Lactose, Cherry Flavor, Saccharin Sodium, Magnesium Stearate.

Dispense in light resistant, tight container as defined in the USP.
Keep bottle tightly closed.

Keep Out of the Reach of Children.

Manufactured for: Kirkman Laboratories, Inc., Lake Oswego, OR 97035

FL035

Specially Packaged for
MULTNOMAH COUNTY OREGON

Sodium Fluoride 2.21 MG

NDC: 58223-679-04

1000 TABLETS

Cherry Flavored
Chewable Tablets USP
Dye-free


Each tablet contains 2.21 mg of Sodium Fluoride equivalent to 1.0 mg of the fluoride ion.

CAUTION: Federal law prohibits dispensing without prescription.

Keep bottle tightly closed.

INGREDIENTS: Sodium Fluoride USP, Lactose, Cherry Flavor, Saccharin Sodium, Magnesium Stearate.

IMPORTANT: Keep bottle in a locked area away from children, food and extreme hot or cold temperatures. Do not store in a refrigerator. For complete instructions, see package insert.

In case of suspected overdose call Poison Control at 1-800-222-1222

KIRKMAN LABORATORIES INC.
LAKE OSWEGO, OR 97035

LABEL P/N #: FL034
Bulk #: 679-04
Lot #: 00000000
Pkg. Date: 00/00
Exp. Date: 00/00

 

BERMUDA GOVERNMENT PREVENTIVE DENTAL PROGRAM

For School Use Only

Sodium Fluoride 2.21 MG
(1.0 mg Fluoride)

1000 TABLETS

FOR CLASS DISTRIBUTION ONLY

DAILY DOSE: One tablet per child per day for children ages 6-13.

*KEEP THIS BOTTLE OUT OF REACH OF CHILDREN*

• It is important to keep to the correct dosage.
• Do not give these tablets along with any other tablets that contain fluoride (such as vitamin-fluoride combinations)
• Keep this bottle in a safe, cool place.
• For further information, Tel. (441) 278-6440.
  Senior Dental Office, Dept. of Health
  Victoria Street, Hamilton Bermuda

Each tablet contains 2.21 mg of Sodium Fluoride USP, equivalent to 1.0 mg of the fluoride ion.

INGREDIENTS: Sodium Fluoride USP, Lactose, Cherry Flavor, Saccharin Sodium, Magnesium Stearate.

DYE FREE!

KIRKMAN LABORATORIES INC.
LAKE OSWEGO, OR 97035

LABEL P/N #: FL045
Bulk #: 679-04
Lot #: 00000000
Pkg. Date: 00/00
Exp. Date: 00/00

BERMUDA GOVERNMENT PREVENTIVE DENTAL PROGRAM

For Individual Use Only

Sodium Fluoride 2.21 MG
(1.0 mg Fluoride)

For Home Treatment (70 Tablets)

Name: ____________________________________
School:________________________ Grade:_____

DAILY DOSE: One tablet per child per day for children ages 6 to 13.

• KEEP OUT OF THE REACH OF CHILDREN.
• It is important to keep to the correct dosage.
• Do not give these tablets along with any other tablets that contain fluoride (such as vitamin-fluoride combinations)
• Keep this bottle in a safe, cool place.
• For further information, Tel. (441) 278-6440
  Senior Dental Office, Dept. of Health
  Victoria Street, Hamilton Bermuda


Each tablet contains 2.21 mg of Sodium Fluoride USP, equivalent to 1.0 mg of the fluoride ion.

INGREDIENTS: Sodium Fluoride USP, Lactose, Cherry Flavor, Saccharin Sodium, Magnesium Stearate.

DYE FREE!

KIRKMAN LABORATORIES INC.
LAKE OSWEGO, OR 97035

LABEL P/N #: FL044
Bulk #: 679-70
Lot #: 00000000
Pkg. Date: 00/00
Exp. Date: 00/00

 

SODIUM FLUORIDE

SODIUM FLUORIDE TABLET, CHEWABLE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:58223-679(NDC:0288-2203)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 1 mg

Inactive Ingredients

Ingredient Name Strength
LACTOSE
saccharin sodium
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
white 7 mm F2 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58223-679-01 100 in 1 BOTTLE
2 NDC:58223-679-04 1000 in 1 BOTTLE
3 NDC:58223-679-09 5000 in 1 BOTTLE
4 NDC:58223-679-70 70 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-10-01


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Be sure to consult your doctor before taking any medication!
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