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Multivitamin with Fluoride Chewable Tablets Prescribing Information

Package insert / product label
Dosage form: tablet, chewable
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Feb 15, 2024.

Multivitamin with Fluoride Chewable Tablets Description

Nutrition Fact

* Daily Value (% DV) not established

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.

Multivitamin with Fluoride Chewable Tablets - 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:

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

Indications and Usage for Multivitamin with Fluoride Chewable Tablets

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.

Warnings

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:

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






Adverse Reactions/Side Effects

Allergic rash and other idiosyncrasies have been rarely reported.

Multivitamin with Fluoride Chewable Tablets Dosage and Administration

One tablet daily or as prescribed.

How is Multivitamin with Fluoride Chewable Tablets supplied

3.25 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.170.99-3.0
Rev: 01/2024

Package/Label Display Panel

Multivitamin with Fluoride Chewable Tablets 0.25 mg 100 count

Multivitamin with Fluoride Chewable Tablets 0.5 mg 100 count

Multivitamin with Fluoride Chewable Tablets 1.0 mg 100 count

MULTIVITAMIN WITH FLUORIDE
sodium fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75826-170
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A750 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID24 mg
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID36 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-6.75 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.05 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.2 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE13.5 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.05 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID500 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics
Colorred (Peach colored) Scoreno score
ShapeROUNDSize13mm
FlavorGRAPE (Grape flavor) Imprint CodeWL170
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75826-170-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2023
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2023
MULTIVITAMIN WITH FLUORIDE
sodium fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75826-169
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A750 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID24 mg
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID36 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-6.75 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.05 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.2 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE13.5 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.05 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID500 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
Product Characteristics
Colorpink (Pink Colored) Scoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint CodeWL169
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75826-169-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2024
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2023
MULTIVITAMIN WITH FLUORIDE
sodium fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75826-171
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A750 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID24 mg
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID36 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-6.75 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.05 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.2 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE13.5 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.05 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID500 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
Product Characteristics
Colorpurple (Purple colored) Scoreno score
ShapeROUNDSize13mm
FlavorGRAPE (Grape flavor) Imprint CodeWL171
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75826-171-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2023
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2023
Labeler - WINDER LABORATORIES, LLC (965195170)
Establishment
NameAddressID/FEIBusiness Operations
WINDER LABORATORIES, LLC965195170manufacture(75826-169, 75826-170, 75826-171)