MultiVitamin with Fluoride Dailymed
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Dosage And Administration
One tablet daily or as directed by a physician.
Statement Of Identity Section
Supplement Facts Serving Size 1 Tablet Servings Per Container 100 Amount Per Serving % Daily Value Vitamin A 750 mcg (2500 IU) 83% Vitamin C 60 mg 67% Vitamin D 10 mcg (400 IU) 50% Vitamin E 6.75 mg (15 IU) 45% Thiamine 1.05 mg 88% Riboflavin 1.2 mg 92% Niacinamide 13.5 mg 84% Vitamin B6 1.05 mg 62% Folate (Folic Acid) 500 mcg DFE (0.3 mg) 125% Vitamin B12 4.5 mcg 188% Fluoride 0.25 mg Daily Value not established        Â
Warning
KEEP OUT OF THE REACH OF CHILDREN.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Health Claim Section
Other Ingredients: ascorbic acid, cholecalciferol, compressible sugar, cyanocobalamin, dl-alpha-tocopheryl acetate, FD&C Yellow #6 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, natural and artificial orange flavor, niacinamide, polyethylene glycol, pyridoxine HCl, riboflavin, sodium ascorbate, sodium fluoride, stearic acid, sucralose, thiamine mononitrate and vitamin A acetate.
Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.
Clinical Pharmacology
Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.
MultiVitamin with Fluoride 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(OH2) + 2F- Ca10 (PO4)6F2 + 2OH- Â Â Â Â Â Â (Hydroxyapatite) Â Â Â Â Â Â Â Â (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 of saliva.
Dietary Supplementation
MultiVitamins with Fluoride Chewable Tablets offer supplementation of the diet with 10 vitamins and fluoride.
Warnings
AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN. This tablet should be chewed. This product, as with all chewable tablets, are not recommended for children under the age of 4 due to risk of choking.
Precautions
The suggested dose of MultiVitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before recommending MultiVitamin with 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.
Adverse Reactions
Allergic rash and other idiosyncrasies have been rarely reported.
To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma, LLC at 1 (866) 592-6438 or FDA at 1 (800) 332-1088 or via the web at www.fda.gov/medwatch/index.html for voluntary reporting of adverse reactions.
Dosage And Administration
One tablet daily or as directed by a physician.
How Supplied
MultiVitamin with Fluoride Chewable Tablets 0.25 mg are available as orange chewable tablets imprinted with "155" in 100 tablet bottles.
MultiVitamin with Fluoride Chewable Tablets 0.5 mg are available as orange chewable tablets imprinted with "156" in 100 tablet bottles.
MultiVitamin with Fluoride Chewable Tablets 1.0 mg are available as orange chewable tablets imprinted with "157" in 100 tablet bottles.
STORAGE
Store at controlled room temperature 20°C-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F) [See USP].
Tamper Evident
Do not use if seal under cap is torn, broken or missing.
Health Claim Section
Distributed by: H2-Pharma, LLC Montgomery, AL 36117
Principal Display Panel - 0.25 Mg Tablet Bottle Label
61269-155-01
MultiVitamin with Fluoride Chewable Tablets
0.25 mg
MultiVitamin and Fluoride Supplement
Dietary Supplement Orange Flavor
100 Tablets
H2 pharma
Principal Display Panel - 0.5 Mg Tablet Bottle Label
61269-156-01
MultiVitamin with Fluoride Chewable Tablets
0.5 mg
MultiVitamin and Fluoride Supplement
Dietary Supplement Orange Flavor
100 Tablets
H2 pharma
Principal Display Panel - 1 Mg Tablet Bottle Label
61269-157-01
MultiVitamin with Fluoride Chewable Tablets
1 mg
MultiVitamin and Fluoride Supplement
Dietary Supplement Orange Flavor
100 Tablets
H2 pharma
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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