SODIUM FLUORIDE CHERRY- sodium fluoride tablet, chewable

SODIUM FLUORIDE by

Drug Labeling and Warnings

SODIUM FLUORIDE by is a Prescription medication manufactured, distributed, or labeled by HTO Nevada Inc., Medical Products Laboratories, KIRKMAN LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION:

Kirkman's 2.21 mg (1.0 mg fluoride ion) Sodium Fluoride Tablets are dye free.  Each 2.21 mg (full strength) tablet contains 1.0 mg of the fluoride ion (F) from 2.21 mg sodium fluoride (NaF).  Each tablet for oral administration contain sodium fluoride equivalent to 1.0 mg of the fluoride ion and the following inactive ingredients: Lactose, Cherry Flavor, Saccharin Sodium and Magnesium Stearate.

CLINICAL PHARMACOLOGY:

Sodium fluoride acts systemically (before tooth eruption ) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization , and by inhibiting the cariogenic microbial process. 

INDICATIONS AND USAGE:

For once daily, self-administered, systemic use as a dental caries preventive in pediatric patients.  It has been established that ingestion of fluoridated drinking water ( 1 ppm F ) during the period of tooth development results in a significant decrease in the incidence of dental caries.  Kirkman's 2.21 mg Sodium Fluoride Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients form 6 months to 16 years of age living in areas where the drinking water fluoride content does not exceed 0.6 ppm (F).

CONTRAINDICATIONS:

Krikman's 2.21 mg Sodium Fluoride Tablets, are contraindicated when the fluoride content of drinking water is 0.6 ppm (F) or more and should not be administered to pediatric patients under the age of 6 months.  Do not administer fluoride (any strength) to pediatric patients under age 6 months.

WARNINGS:

Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm.  Read directions carefully before using. 

PRECAUTIONS:

General:  Please refer to CONTRAINDICATIONS, WARNINGS, and OVERDOSAGE sections for overdose concerns.  Use in pediatric patients below the age of 6 months is not recommended by current American Dental Association and American Academy of Pediatrics guidelines. 

Drug Interactions:

Do not eat or drink dairy products within one hour of fluoride administration.  Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

Nursing Mothers:

It is not known if fluoride ion is excreted in human milk.  However, many drugs are excreted in human milk and caution should be exercised when Kirkman's 2.21 mg Sodium Tablets are administered to nursing women.

Pediatric Use:

The use of Kirkman's 2.21 mg Sodium Fluoride Tablets as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well-controlled studies on fluoride supplementation from birth through adolescence.

Geriatric Use:

Not indicated for use in geriatric patients.

ADVERSE REACTIONS:

Allergic rash and other idiosyncrasies have rarely been reported.  Call your doctor for medical advice about side effects.  You may report side effects tot the FDA at 1-800-FDA-1088.

OVERDOSAGE:

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue.  Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain.  These symptoms may persist for up to 24 hours.  If less than 5 mg sodium fluoride/kg body weight (i.e. less than 2.3 mg sodium fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g. milk, 5% calcium gluconate, or calcium lactate solution) and immediately seek medical assistance.  For accidental ingestion of more than 15 mg sodium fluoride/kg of body weight (i.e. more than 6.9 mg sodium fluoride/lb of body weight), induce vomiting and seek emergency medical help.

DOSAGE AND ADMINISTRATION:

Follow the direction for using this medication provided by your doctor.

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

STORAGE AND HANDLING

Store at Controlled Room Temperature, 20-25 °C (68-77 °F).  See USP "Controlled Room" for further information.

NDC: 58223-679-01

Manufactured for KIRKMAN Laboratories, Inc
17387 SW 63rd Ave.
Lake Oswego, OR 97035

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

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

 

INGREDIENTS AND APPEARANCE

SODIUM FLUORIDE   CHERRY
sodium fluoride tablet, chewable

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 58223-679
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1 mg

Inactive Ingredients
Ingredient Name	Strength
Lactose (UNII: J2B2A4N98G)
Saccharin Sodium (UNII: SB8ZUX40TY)
Magnesium Stearate (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor	CHERRY	Imprint Code	F2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58223-679-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2011
2	NDC: 58223-679-04	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2011
3	NDC: 58223-679-70	70 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2011
4	NDC: 58223-679-09	5000 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2011	12/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2011

Labeler - HTO Nevada Inc. (117115846)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories		002290302	MANUFACTURE(58223-679)

Establishment
Name	Address	ID/FEI	Business Operations
KIRKMAN LABORATORIES INC		180802803	REPACK(58223-679)