MULTIVITAMIN WITH FLUORIDE- sodium fluoride tablet, chewable
Multivitamin with Fluoride by
Drug Labeling and Warnings
Multivitamin with Fluoride by is a Prescription medication manufactured, distributed, or labeled by WINDER LABORATORIES, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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Rx Only
* 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. -
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.
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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.
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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.
- Determine the fluoride content of the drinking water from all major sources.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
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HOW 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
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INGREDIENTS AND APPEARANCE
MULTIVITAMIN WITH FLUORIDE
sodium fluoride tablet, chewableProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 75826-170 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 750 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 24 mg SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 36 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 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) THIAMINE 1.05 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.2 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 13.5 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 1.05 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 500 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4.5 ug Inactive Ingredients Ingredient Name Strength 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 Color red (Peach colored) Score no score Shape ROUND Size 13mm Flavor GRAPE (Grape flavor) Imprint Code WL170 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 75826-170-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2023 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/01/2023 MULTIVITAMIN WITH FLUORIDE
sodium fluoride tablet, chewableProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 75826-169 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.25 mg VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 750 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 24 mg SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 36 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 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) THIAMINE 1.05 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.2 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 13.5 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 1.05 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 500 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4.5 ug Inactive Ingredients Ingredient Name Strength 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 Color pink (Pink Colored) Score no score Shape ROUND Size 13mm Flavor GRAPE Imprint Code WL169 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 75826-169-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2024 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/01/2023 MULTIVITAMIN WITH FLUORIDE
sodium fluoride tablet, chewableProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 75826-171 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 VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 750 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 24 mg SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 36 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 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) THIAMINE 1.05 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.2 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 13.5 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 1.05 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 500 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4.5 ug Inactive Ingredients Ingredient Name Strength 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 Color purple (Purple colored) Score no score Shape ROUND Size 13mm Flavor GRAPE (Grape flavor) Imprint Code WL171 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 75826-171-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2023 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/01/2023 Labeler - WINDER LABORATORIES, LLC (965195170) Establishment Name Address ID/FEI Business Operations WINDER LABORATORIES, LLC 965195170 manufacture(75826-169, 75826-170, 75826-171)
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