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Multivitamin with Fluoride

sodium fluoride · Multivitamin with Fluoride is a vitamin a (prescription) containing sodium fluoride, made by WINDER LABORATORIES, LLC.

Type
Prescription
Drug class
Vitamin A
Route
Oral
Manufacturers
1

Supplementation of the diet with fluoride and ten essential vitamins.

Drug facts

Generic name
sodium fluoride
Active ingredients
.alpha.-Tocopherol Acetate, Dl-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Sodium Ascorbate, Sodium Fluoride, Thiamine Mononitrate, Vitamin a
Drug class
Vitamin AVitamin B12Vitamin CVitamin D
Dosage forms
Tablet, chewable
Label holder
WINDER LABORATORIES, LLC
Label updated
08/27/2025

Uses

Supplementation of the diet with fluoride and ten essential vitamins. Multivitamin with 1.0 mg Fluoride Chewable Tablets provide 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 Tablet s 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 Tablets provide 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 Tablets supply 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 Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Multivitamin with Fluoride Chewable tablets are prescription product for the clinical dietary management of metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

Dosage and administration

One tablet daily or as prescribed.

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. 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 Tablets should 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.

Side effects (adverse reactions)

Allergic rash and other idiosyncrasies have been rarely reported.

Description

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. Nutrition Fact

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

Forms and strengths

From the FDA NDC Directory · 3 product codes

Dosage formStrengthRouteNDCs
Tablet, chewable.25 mg / 750 ug / 24 mg / 36 mg / 10 ug / 6.75 mg / 1.05 mg / 1.2 mg / 13.5 mg / 1.05 mg / 500 ug / 4.5 ugoral1
Tablet, chewable.5 mg / 750 ug / 24 mg / 36 mg / 10 ug / 6.75 mg / 1.05 mg / 1.2 mg / 13.5 mg / 1.05 mg / 500 ug / 4.5 ugoral1
Tablet, chewable1 mg / 750 ug / 24 mg / 36 mg / 10 ug / 6.75 mg / 1.05 mg / 1.2 mg / 13.5 mg / 1.05 mg / 500 ug / 4.5 ugoral1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 3,662 reports that list sodium fluoride, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Fatigue342
  • Nausea313
  • Pain286
  • Diarrhea274
  • Vomiting244
  • Pneumonia235
  • Pyrexia235
  • Dizziness233
  • Headache229
  • Weight decreased225

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

  • WINDER LABORATORIES, LLCShown hereLabel 08/27/2025 · NDC 75826-169, 75826-170, 75826-171Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Multivitamin with Fluoride: common questions

What is Multivitamin with Fluoride used for?
Supplementation of the diet with fluoride and ten essential vitamins.
What are the side effects of Multivitamin with Fluoride?
Allergic rash and other idiosyncrasies have been rarely reported. See the full side effects section on this page, and ask your doctor or pharmacist about any side effect that bothers you.
Is Multivitamin with Fluoride a prescription drug?
Yes. Multivitamin with Fluoride is a prescription (Rx) drug.
Are there other products with the same active ingredient as Multivitamin with Fluoride?
Yes. Other FDA-listed products with the same active ingredients include Flotrex, Flotrex, Flotrex.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 08/27/2025 · Label text is shown as published by the manufacturer. Not medical advice