Label: ESCAVITE LQ- vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacin, pyridoxine hydrochloride, cyanocobalamin, ferric pyrophosphate, ferrous cysteine glycinate, and sodium fluoride liquid
- NDC Code(s): 58809-877-50
- Packager: GM Pharmaceuticals, INC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated December 2, 2016
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- SPL UNCLASSIFIED SECTION
Active ingredient for caries prophylaxis:
Each 1 mL contains 0.25 mg fluoride as sodium fluoride.Close
Prescription drug multi-vitamin with iron and fluoride 0.25 mg drops
Each 1.0 mL contains (mark on dropper)
Vitamin A 1,500 IU Vitamin C 35 mg Vitamin D 400 IU Vitamin E 7.5 IU Thiamine 0.5 mg Riboflavin 0.6 mg Niacin 8 mg Vitamin B6 0.4 mg Vitamin B12 0.9 mcg Iron 6 mg Fluoride 0.25 mg
- Other ingredients:
Ascorbic Acid (Vitamin C), Carrageenan, Cholecalciferol (Vitamin D3), Citric Acid, Cyanocobalamin (Vitamin B12), D-alpha-tocopheryl acetate (Vitamin E), Ferrous Glycine Cysteinate, Ferric Pyrophosphate, Glycerin, Niacin, Orange Flavor, Potassium Sorbate, Propylene Glycol, Purified Water, Pyridoxine Hydrochloride (Vitamin B6), Riboflavin (Vitamin B2), Thiamin Hydrochloride (Vitamin B1), Vitamin A Palmitate, and Sucralose.Close
- CLINICAL PHARMACOLOGY:
It is well established that fluoridation of the water supply (1ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. 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. Three stages of fluoride deposition in tooth enamel can be distinguished:1
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.Close
- INDICATIONS AND USAGE:
Supplementation of the diet with nine essential vitamins and iron, and 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.2
Escavite® LQ Multi-vitamin with Iron and Fluoride 0.25 mg provides fluoride in drop form for infants and young children from 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3-6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.2,3
Each 1.0 ml supplies sodium fluoride (0.25 mg fluoride per 1 mL) plus nine essential vitamins and iron.
Escavite® LQ Multi-vitamin with Iron and Fluoride 0.25 mg supplies significant amounts of vitamins A,C,D,E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and iron to supplement the diet, and to help assure the deficiencies of these nutrients will not develop. Thus, in a single easy-to-use preparation, infants and children obtain nine essential vitamins and iron, plus fluoride.Close
As in the case of all medications, keep out of reach of children.
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 overdose, call a doctor or poison control center immediately.Close
The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride.
When prescribing Escavite® LQ Multi-vitamin with Iron and Fluoride 0.25 mg drops: 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
Escavite® LQ Multi-vitamin with Iron and Fluoride 0.25 mg drops should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50-mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)Close
- 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.Close
- ADVERSE REACTIONS:
Allergic rash and other idiosyncrasies have been rarely reported. To report adverse side effects or to obtain product information, contact GM Pharmaceuticals, Inc. at 1-888-535-0305.Close
Prolonged daily ingestion of excessive fluoride will result in varying degrees of Fluorosis.Close
- DOSAGE AND ADMINISTRATION:
1 mL daily, or as prescribed. May be dropped directly into mouth with dropper, or mixed with fruit juice, cereal or other food.Close
- HOW SUPPLIED:
Escavite® LQ Multi-vitamin with Iron and Fluoride 0.25 mg drops is an orange to dark orange liquid with an orange odor available in 50 mL bottles with accompanying calibrated dropper.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59-86°F). See USP Controlled Room Temperature. Protect from light and moisture. Close tightly after each use.
Shake Well. Use calibrated dropper.Close
- KEEP OUT OF REACH OF CHILDREN.
Occasional deepening of color has no significant effect on vitamin potency.
While taking drops with iron, a slight darkening of the teeth may occur. Brushing will minimize this temporary condition.
After opening, store away from direct light.
Your doctor or dentist is the best source of counsel and guidance in your child’s fluoride supplementation.Close
1. Brudevold 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 Co.; 1966;331-347.
2. American Academy of Pediatrics, Committee on Nutrition: Fluoride Supplementation for Children: Interim Policy Recommendations. AAP News, February 1995, pg 18.
3. American Dental Association Council on Dental Therapeutics. New Fluoride Schedule Adopted. ADA News. May 16, 1994;12-14.
GM Pharmaceuticals, Inc., Arlington, TX 76015
Covered by U.S. Patent No. 7,341,708.
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
MULTI-VITAMIN WITH IRON
AND FLUORIDE 0.25 mg
50 mL (1.69 FL. OZ.)
- INGREDIENTS AND APPEARANCE
vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacin, pyridoxine hydrochloride, cyanocobalamin, ferric pyrophosphate, ferrous cysteine glycinate, and sodium fluoride liquid
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58809-877 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 1500 [iU] in 1 mL ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 35 mg in 1 mL CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] in 1 mL .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 7.5 [iU] in 1 mL THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (Thiamine ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 0.5 mg in 1 mL RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 0.6 mg in 1 mL NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 8 mg in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 0.4 mg in 1 mL CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 0.9 ug in 1 mL FERRIC PYROPHOSPHATE (UNII: QK8899250F) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION 5 mg in 1 mL FERROUS CYSTEINE GLYCINATE (UNII: 8B4OP7RK5N) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 1 mg in 1 mL SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARRAGEENAN (UNII: 5C69YCD2YJ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color ORANGE Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58809-877-50 1 in 1 CARTON 08/20/2013 1 50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 08/20/2013 Labeler - GM Pharmaceuticals, INC (793000860)