solutions Escavite D Generic Name: multi-vitamin supplement with iron and fluoride Dosage Form: tablet, chewable Overview Side Effects Dosage Professional Interactions More User Reviews Pricing & Coupons Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. ESCAVITE D MULTI-VITAMIN SUPPLEMENT WITH IRON AND FLUORIDE CHEWABLE TABLETS 0.25 mg Rx Only Nutrition Facts Serving Size: 1 Chewable Tablet Amount Per Tablet % Daily Value Adults & Children 4 Years or More * CitraFolic is a controlled-release form of folic acid that is pH-specific using citrates as buffers to achieve optimal absorption for targeted-GI at the proximal jejunum AND in order to meet USP requirements for folic acid dissolution and disintegration; it is patent pending. CitraFolic uses only DMF-approved manufacturers of folic acid. AminoFerr as ferrous glycine cysteinate, also known as FERROUS CYSTEINE GLYCINATE, and has the Unique Ingredient Identifier (UNII) code 8B4OP7RK5N. AminoFerr is a proprietary ingredient containing pure chelates without interfering ions resulting in high solubility and adsorption; it is the only pure amino acid iron chelate supplement on the market, and is protected under US Patent No. 7,341,708. Daily value not established. Vitamin A (as beta carotene) 2500 IU 50% Vitamin C (as ascorbic acid) 100 mg 167% Vitamin D (as cholecalciferol) 600 IU 150% Vitamin E (as dl-alpha tocopheryl acetate) 30 IU 100% Thiamine (as thiamine HCl, vitamin B 1 ) 1.5 mg 100% Riboflavin 1.7 mg 100% Niacin (as nicotinic acid) 20 mg 100% Vitamin B 6 (as pyridoxine HCl) 2 mg 100% Folic Acid, USP as CitraFolic * [from controlled -release Citrated-pteroylmonoglutamic Acid] 400 mcg 100% Vitamin B 12 (as hydroxocobalamin) 6 mcg 100% Biotin 45 mcg 15% Pantothenic Acid (as d-calcium pantothenate) 10 mg 100% Iron (elemental) as AminoFerr [from ferrous glycine cysteinate] 6 mg 33% Magnesium (as magnesium oxide) 60 mg 15% Zinc (as zinc oxide) 15 mg 100% Copper (as cupric oxide) 2 mg 100% Fluoride (as sodium fluoride) 0.25 mg Ingredient for caries prophylaxis: Fluoride as sodium fluoride. Other Ingredients: Citric Acid, Cherry Flavor, Dextrose Cerelose, Fumed Silica, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Sorbitol, Stearic Acid, Sucralose, Xylitol. Slideshow Sports And Dietary Supplements: From Creatine To Whey PHARMACOLOGY It is well established that fluoridation of the water supply (1 ppm fluoride) during period of tooth development leads to a significant decrease in the incidence of dental caries. Escavite D Multi-vitamin with Iron and Fluoride Chewable Tablets provide sodium fluoride, magnesium, zinc, copper, twelve essential vitamins, and iron in a chewable tablet. Because 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) 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 water, food supplementary fluoride and smaller amounts from saliva. Indications and Usage for Escavite D Escavite D Multi-vitamin with Iron and Fluoride Chewable Tablets is a prescription product for the dietary management of the metabolic processes of caries prophylaxis, and provides supplementation of the diet with twelve essential vitamins, magnesium, zinc, copper and iron. Escavite D Multi-vitamin with Iron and Fluoride Chewable Tablets provide 0.25mg of fluoride in a chewable tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride. Escavite D Multi-vitamin with Iron and Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B 6 , folate, vitamin B 12 , biotin, pantothenic acid, 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 twelve essential vitamins and the important minerals, magnesium, zinc, copper, iron, and fluoride. The American Academy of Pediatrics recommends that children up to the age of 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Children using Escavite D Multi-vitamin with Iron and Fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. This statement has not been evaluated by the food and drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Warnings This product contains iron. WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdosage, call a doctor or a poison control center immediately. Tablets should be chewed or crushed before they are swallowed. This product is not recommended for children under age 4 due to risk of choking. Precautions The suggested dose of Escavite D Multi-vitamin with Iron and Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Before prescribing Escavite D Multi-vitamin with Iron and Fluoride 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. Your doctor or dentist is the best source of counsel and guidance in your child's fluoride supplementation. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Drug Interactions Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Adverse Reactions Allergic rash and other idiosyncrasies have been rarely reported. To report adverse side effects or to obtain product information, contact GM Pharmaceuticals at 1-888-535-0305. RECOMMENDED USE Chew one tablet daily or as prescribed by doctor, or dentist. How is Escavite D Supplied Escavite D Multi-vitamin with Iron and Fluoride Chewable Tablets 0.25 mg are dye free, off-white speckled, round shaped, cherry-flavored chewable tablets debossed with E on one side and plain on the other. They are available in bottles of 60 chewable tablets (Product Code 58809-829-60) and 1 count physician samples (Product Code 58809-829-02). STORAGE Store at 25 C (77 F); excursions permitted to 15 -30 C (59 -86 F). See USP Controlled Room Temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. KEEP OUT OF REACH OF CHILDREN REFERENCES 1. Brudevoid F, McCann HG: Fluoride and caries control- Mechanism of action, in Nizel AE, Ed: The Science of Nutrition and its Application in Clinical Dentistry. Philadelphia, WB Saunders Company, 1966, pp 331-347. 2. American Academy of Pediatrics, Committee on Nutrition: Fluoride Supplementation for Children: Interim Policy Recommendations. Pediatrics. 1995; 95 (5):777. 3. American Dental Association Council on Dental Therapeutics. New Fluoride Schedule Adopted. ADA News. May 16, 1994; 12-14. Manufactured for: GM Pharmaceuticals, Inc. Arlington, TX 76015 MADE IN CANADA Rev. 02/14 Covered by US Patent No. 7,341,708 and patent pending. PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label 58809-829-60 Escavite D MULTI-VITAMIN SUPPLEMENT WITH IRON AND FLUORIDE 0.25 mg Cherry Flavored CHEWABLE TABLETS Rx Only G MPharmaceuticals, Inc. 60 Tablets Escavite D .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacin, pyridoxine hydrochloride, folic acid, hydroxocobalamin, biotin, calcium pantothenate, ferrous cysteine glycinate, magnesium oxide, zinc oxide, cupric oxide, and sodium fluoride tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58809-829 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 2500 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 600 [iU] .ALPHA.-TOCOPHEROL, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU] THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 1.5 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.7 mg NIACIN (NIACIN) NIACIN 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 2 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 400 ug HYDROXOCOBALAMIN (HYDROXOCOBALAMIN) HYDROXOCOBALAMIN 6 ug BIOTIN (BIOTIN) BIOTIN 45 ug CALCIUM PANTOTHENATE (PANTOTHENIC ACID and CALCIUM CATION) PANTOTHENIC ACID 10 mg FERROUS CYSTEINE GLYCINATE (FERROUS CATION) FERROUS CATION 6 mg MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 60 mg ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 mg CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE CHERRY DEXTROSE SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SORBITOL STEARIC ACID SUCRALOSE XYLITOL Product Characteristics Color WHITE (off-white, speckled) Score no score Shape ROUND Size 16mm Flavor Imprint Code E Contains Packaging # Item Code Package Description 1 NDC:58809-829-60 60 TABLET, CHEWABLE in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 03/03/2014 Labeler - GM Pharmaceuticals, Inc. (793000860) Revised: 03/2014 GM Pharmaceuticals, Inc. Next Interactions Print this page Add to My Med List More about Escavite D (multivitamin with iron and fluoride) Side Effects Dosage Information Drug Interactions Pricing & Coupons 0 Reviews Add your own review/rating Consumer resources Escavite D Professional resources Multi-Vit with Fluoride and Iron (FDA) Other brands: Escavite , Tri-Vitamin Drops with Iron and Fluoride , Tri-Vit with Fluoride and Iron Drops Related treatment guides Dietary Supplementation} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Related Drugs Dietary Supplementation biotin , multivitamin , Fish Oil , ascorbic acid , Coenzyme Q10 , Lovaza , CoQ10 , calcium citrate , Zinc , chondroitin / glucosamine , Citracal + D , Probiotic Formula , calcium / vitamin d , pyridoxine , Dextrose , Caltrate 600+D , Osteo Bi-Flex , Alpha-Lipoic-Acid-300 , More... 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