Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied: Davimet™ with Flouride 0.75 mg Chewable Multivitamin are light purple with speckles, grape flavored, un-scored, round tablets. Available on prescription only in bottle of 30 tablets – NDC 59088-170-54.; Davimet™ with Flouride 0.75 mg Chewable Multivitamin Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 label
- How Supplied: Davimet™ with Flouride 0.75 mg Chewable Multivitamin are light purple with speckles, grape flavored, un-scored, round tablets. Available on prescription only in bottle of 30 tablets – NDC 59088-170-54.
- Davimet™ with Flouride 0.75 mg Chewable Multivitamin Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 label
Overview
Each Chewable Tablet Contains: Vitamin A (as Retinyl Acetate)............................................. 750 mcg RAE Vitamin C (as Sodium Ascorbate 36 mg and Ascorbic Acid 24 mg)............... 60 mg Vitamin D3 (as Cholecalciferol)......................................... 10 mcg (400IU) Vitamin E (as DL-Alpha Tocopheryl Acetate)............................... 6.75 mg Thiamin (as Thiamine Mononitrate)............................................. 1.05 mg Riboflavin...................................................................................... 1.2 mg Niacin (as Niacinamide)............................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride)................................... 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)........…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin).............................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................... 0.75 mg Davimet™ with Flouride 0.75 mg Chewable Multivitamin active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Davimet™ with Flouride 0.75 mg Chewable Multivitamin provide sodium fluoride and ten essential vitamins in a chewable tablet. Other Ingredients : Aspartame, Croscarmellose Sodium, Natural Grape Flavor, Magnesium Stearate (Vegetable Source), Maltodextrin, Microcrystalline Cellulose, Stearic Acid (Vegetable Source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.
Indications & Usage
: Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Contraindications : This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Davimet™ with Flouride 0.75 mg Chewable Multivitamin provide 0.75 mg fluoride in tablet form for children 6-16 years of age in areas where the drinking water fluoride level is less than 0.3 ppm. Davimet™ with Flouride 0.75 mg Chewable Multivitamin 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. Children using Davimet™ with Flouride 0.75 mg Chewable Multivitamin regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Davimet™ with Flouride 0.75 mg Chewable Multivitamin 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
Folate: Allergic sensitization has been reported following both oral and parenteral administration of folate. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels.
Storage & Handling
Storage: Store at 20° to 25°C (68° to 77°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.
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