Multivitamin with Fluoride

Multivitamin with Fluoride .ALPHA. TOCOPHEROL ACETATE DL ASCORBIC ACID CYANOCOBALAMIN FOLIC ACID NIACIN PYRIDOXINE RIBOFLAVIN SODIUM FLUORIDE THIAMINE MONONITRATE VITAMIN A AND VITAMIN D METHOD PHARMACEUTICALS, LLC FDA Approved INDICATIONS AND USAGE Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Multivitamin with Fluoride 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride 0.25 mg 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. 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 supplements. Children using Multivitamin with Fluoride 0 . 25 mg 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 is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

Generic: .ALPHA. TOCOPHEROL ACETATE DL ASCORBIC ACID CYANOCOBALAMIN FOLIC ACID NIACIN PYRIDOXINE RIBOFLAVIN SODIUM FLUORIDE THIAMINE MONONITRATE VITAMIN A AND VITAMIN D

Mfr: METHOD PHARMACEUTICALS, LLC FDA Rx Only

Substance Alpha Tocopherol Acetate Dl

Route

ORAL

Product NDC

58657-0163-00 58657-0163-90 58657-0163-01

Package NDC

58657-163-90 58657-163-01

Drug Facts

Composition & Profile

Strengths

0.25 mg

Quantities

90 count 100 count 90 tablets 100 tablets

Treats Conditions

Indications And Usage Supplementation Of The Diet With Ten Essential Vitamins Supplementation Of The Diet With Fluoride For Caries Prophylaxis Multivitamin With Fluoride 0 25 Mg Chewable Tablets Provide 0 25 Mg Fluoride In Tablet Form For Children 4 6years Of Age In Areas Where The Drinking Water Contains 0 3 Through 0 6 Ppm Of Fluoride Multivitamin With Fluoride 0 25 Mg 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 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 Supplements Children Using Multivitamin With Fluoride 0 25 Mg 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 Is A Prescription Product For The Clinical Dietary Management Of The Metabolic Processes Of Caries Prophylaxis And Provides Supplementation Of The Diet With Ten Essential Vitamins

Pill Appearance

Shape: round Color: yellow Imprint: M163

Identifiers & Packaging

Container Type UNKNOWN

NDC 58657-0163-00

All Product Codes

58657-0163-00 58657-0163-90 58657-0163-01

UPC

0358657163907 0358657163013

UNII

WR1WPI7EW8 PQ6CK8PD0R P6YC3EG204 935E97BOY8 2679MF687A KV2JZ1BI6Z TLM2976OFR 8ZYQ1474W7 8K0I04919X 81G40H8B0T 9VU1KI44GP

SPL Set IDs

42ed15a5-aad6-4ab3-b95b-f9534a419f40

Packaging

HOW SUPPLIED Multivitamin Chewable tablets containing 0.25 mg fluoride are round yellowish/cream tablets with orange and yellow speckles. Debossed with “M163” on one side. NDC: 58657-163-90 (90 count) NDC: 58657-163-01 (100 count); PRINCIPAL DISPLAY PANEL NDC 58657-163-90 Multivitamin with Fluoride Chewable Tablets 0.25 mg Orange Flavor Rx Only 90 Tablets label-90; PRINCIPAL DISPLAY PANEL NDC 58657-163-01 Multivitamin with Fluoride Chewable Tablets 0.25 mg Orange Flavor Rx Only 100 Tablets label-100

Package Descriptions

HOW SUPPLIED Multivitamin Chewable tablets containing 0.25 mg fluoride are round yellowish/cream tablets with orange and yellow speckles. Debossed with “M163” on one side. NDC: 58657-163-90 (90 count) NDC: 58657-163-01 (100 count)
PRINCIPAL DISPLAY PANEL NDC 58657-163-90 Multivitamin with Fluoride Chewable Tablets 0.25 mg Orange Flavor Rx Only 90 Tablets label-90
PRINCIPAL DISPLAY PANEL NDC 58657-163-01 Multivitamin with Fluoride Chewable Tablets 0.25 mg Orange Flavor Rx Only 100 Tablets label-100

Overview

INDICATIONS AND USAGE Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Multivitamin with Fluoride 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride 0.25 mg 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. 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 supplements. Children using Multivitamin with Fluoride 0 . 25 mg 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 is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

Indications & Usage

Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Multivitamin with Fluoride 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride 0.25 mg 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. 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 supplements. Children using Multivitamin with Fluoride 0 . 25 mg 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 is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

Dosage & Administration

One tablet daily, to be dissolved in the mouth or chewed before swallowing. Do not give a chewable tablet to a child younger than 4 years old.

Warnings & Precautions

WARNING Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. CAUTION Do not eat or drink dairy products within one hour of fluoride administration. Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

Adverse Reactions

Allergic rash and other idiosyncrasies have been rarely reported.