MultiVitamin, Iron and Fluoride by H2 Pharma

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Supplement Facts

Serving Size: 1 mL, 1 time daily

Servings Per Container: 50

Amount Per Serving % Daily Value* (Adults and children 4 or more years of age)

Vitamin A 1,500 IU 60%

Vitamin C 35 mg 88%

Vitamin D 400 IU 100%

Vitamin E 5 IU 50%

Thiamin 0.50 mg 71%

Riboflavin 0.60 mg 75%

Niacin 8 mg 89%

Vitamin B6 0.40 mg 57%

Iron 10 mg 100%

Fluoride 0.25 mg †

* Not Present † Daily Value not established.

Other Ingredients: Ascorbic Acid, Caramel color, Cholecalciferol, Citric Acid, D-Alpha-Tocopheryl Acid Succinate, Ferrous Sulfate, Flavor, Glycerin, Methyl Paraben, Niacinamide, Polysorbate 80, purified Water, Pyridoxine Hydrochloride, Riboflavin-5-Phosphate Sodium, Sodium Benzoate, Sodium Fluoride, Sodium Hydroxide, Sucralose, Thiamine Hydrochloride, Vitamin A Palmitate.

Statements

Suggested Use:

Dosage and Administration
Infants and children under 2 years of age: 1.0 mL daily or as recommended by a physician. May be dropped directly into the mouth with the enclosed dropper or mixed with cereal, fruit juice, or other food.

Warnings:

Warnings
As in the case of all medications, keep out of the reach of children.

Precautions
The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When recommending vitamin fluoride products:
1. Determine the fluoride content of the drinking water.
2. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste.
3. Periodically check to make sure that the child does not develop significant dental fluorosis.
4. MultiVitamin, Iron and Fluoride Supplemental Drops 0.25 mg 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.)

Adverse Reactions
Allergic rash or other idiosyncrasies have been rarely reported. To report suspected adverse reactions, contact H2-Pharma at 1-866-592-6438 or FDA at 1-800-FDA-1088 or via the web at www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Tamper Evident: Do not use if printed bottle seal around bottle cap is broken or missing.

Consult your physician for use by infants and children 2 years of age.

Storage:

Recommended Storage
Store at controlled room temperature, 20 degrees-25 degrees C (68 degrees-77 degrees F) [See USP Controlled Room Temperature]. After opening, store away from direct sunlight. Close tightly after each use. Refrigeration is not required.

Other Information:

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. 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- (Hydroxyapatite) -> Ca10(PO4)6F2+20H- (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 form the surface inward is apparently restricted. 3. After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride and small amounts from saliva.

FDA Disclaimer:

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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