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| Product NDC Code | 58657-163 | ||||||||||||||||||||||
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| Drug Name | Multivitamin with fluoride |
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| Type | Brand | ||||||||||||||||||||||
| Pharm Class | Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||||||
| Dosage Form | TABLET, CHEWABLE | ||||||||||||||||||||||
| Labeler Name | Method Pharmaceuticals, LLC | ||||||||||||||||||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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 0 . 25 mg Chewable Tablets provide 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: Ca10(PO4)6(OH)2 + 2F- ------- Ca10(PO4)6F2 + 2OH- (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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Multivitamin with Fluoride .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A and VITAMIN D CITRIC ACID MONOHYDRATE MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE SUCRALOSE TALC XYLITOL VITAMIN A VITAMIN A ASCORBIC ACID ASCORBIC ACID VITAMIN D VITAMIN D .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACIN NIACIN PYRIDOXINE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN SODIUM FLUORIDE FLUORIDE ION yellowish/cream M163
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.MULTIVITAMIN WITH FLUORIDE Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Prescribing Information Each Fluoride Chewable Tablet Contains: Supplement Facts Dosage Size 1 Chewable Tablet Amount per Tablet % DV Adults and Children 4 years or More Vitamin A (as Vitamin A acetate) 2500 IU 50% Vitamin C (as ascorbic acid) 60 mg 100% Vitamin D (as cholecalciferol) 400 IU 100% Vitamin E (dl-alpha tocopherol acetate ) 15 IU 50% Thiamine (as thiamine) 1.05 mg 70% Riboflavin (as riboflavin) 1.2 mg 71% Niacin (as niacinamide) 13.5 mg 68% Vitamin B6 (as pyridoxine HCl) 1.05 mg 53% Folate (as folic acid) 300 mcg 75% Vitamin B12 (as cyanocobalamin) 4.5 mcg 75% Fluoride (as sodium fluoride) 0.25 mg * *Daily value (DV) not established Multivitamin with Fluoride 0 . 25 mg Chewable Tablets active ingredient for caries prophylaxis: Fluoride as sodium fluoride Multivitamin with Fluoride 0 . 25 mg Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Other ingredients: citric acid, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor, sucralose, talc, xylitol.
| Vitamin A (as Vitamin A acetate) | 2500 IU | 50% |
| Vitamin C (as ascorbic acid) | 60 mg | 100% |
| Vitamin D (as cholecalciferol) | 400 IU | 100% |
| Vitamin E (dl-alpha tocopherol acetate ) | 15 IU | 50% |
| Thiamine (as thiamine) | 1.05 mg | 70% |
| Riboflavin (as riboflavin) | 1.2 mg | 71% |
| Niacin (as niacinamide) | 13.5 mg | 68% |
| Vitamin B6 (as pyridoxine HCl) | 1.05 mg | 53% |
| Folate (as folic acid) | 300 mcg | 75% |
| Vitamin B12 (as cyanocobalamin) | 4.5 mcg | 75% |
| Fluoride (as sodium fluoride) | 0.25 mg | * |
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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)
Safe handling warning
Safe Handling WarningSTORAGE 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 For: Method Pharmaceuticals Fort Worth, TX 76118 Rev. 06/2019
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTION The suggested dose of Multivitamin with Fluoride 0 . 25 mg Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Before prescribing Multivitamin with Fluoride 0.25 mg 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API