FDA Label for Multivitamin With Fluoride

Rx Only

Active ingredients:
Fluoride as sodium fluoride.

Other Ingredients: 
Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid, Sucrose.
0.25 mg also contains: D&C Red #27 Alum Lake and FD&C Yellow #6 Alum Lake.
0.5 mg also contains: FD&C Red #40 Alum Lake.
1.0 mg also contains: D&C Red #27 and FD&C Blue #1.

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 Fluoride Chewable Tabletsprovide 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.
Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

Ca ₁₀ (PO ₄) ₆(OH) ₂+ 2F ^-------› Ca ₁₀(PO ₄)F ₂+ 2OH ^-     
(Hydroxyapatite)                        (Fluorapatite)

(Hydroxyapatite) (Fluorapatite)

Three stages of fluoride deposition in tooth enamel can be distinguished:

• Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
• After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
  
• After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.
  

Indications And Usage

Supplementation of the diet with fluoride and ten essential vitamins.

Multivitamin with 1.0 mg Fluoride Chewable Tabletsprovide fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm.

Multivitamin with 0.5 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride.

Multivitamin with 0.25 mg Fluoride Chewable Tabletsprovide fluoride in tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride.

Multivitamin with Fluoride Chewable Tabletssupply significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.
Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.
Supplementation of the diet with fluoride for caries prophylaxis.
The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

Children using Multivitamin with Fluoride Chewable Tabletsregularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

Multivitamin with Fluoride Chewable tabletsare prescription product for the clinical dietary management of metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

Warning Keep This And All Medication Out Of The Reach Of Children. In Case Of Accidental Overdose, Seek Professional Assistance Or Contact A Poison Control Center Immediately.

Keep this and all medication out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

CAUTION
Should be chewed. This product, as with all chewable tablets, is not recommended for children under age 4 due to risk of choking.
Do not eat or drink dairy products within one hour of fluoride administration.

PRECAUTIONS

The suggested dose of Multivitamin with Fluoride Chewable Tabletsshould not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multivitamin with Fluoride Chewable Tablets:

• Determine the fluoride content of the drinking water from all major sources.
  
• Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.
  
• Periodically check to make sure that the child does not develop significant dental fluorosis.
  

Adverse Reactions

Allergic rash and other idiosyncrasies have been rarely reported.

Dosage And Administration

One tablet daily or as prescribed.

How Supplied

0.25 mg: Multivitamin chewable tablets containing 0.25 mg fluoride are pink-colored, grape flavor, un-scored, round tablet, debossed with “WL” “169” on one side and plain on other side of tablet. Available in bottle of 100 (NDC 75826-169-10).

0.5 mg: Multivitamin chewable tablets containing 0.5 mg fluoride are peach-colored, grape flavor, un-scored, round tablet, debossed with “WL” “170” on one side and plain on other side of tablet. Available in bottle of 100 (NDC 75826-170-10).

1.0 mg: Multivitamin chewable tablets containing 1.0 mg fluoride are purple-colored, grape flavor, un-scored, round tablet, debossed with “WL” “171” on one side and plain on other side of tablet. Available in bottle of 100 (NDC 75826-171-10).

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.

Manufactured by:
Winder Laboratories LLC
Winder GA, 30680

RLS.170.99-1.0
Rev: 08/2023