MultiVitamin with Fluoride Drops By H2 Pharma Overview & Drug Interactions

Check For Interactions With MultiVitamin with Fluoride Drops

Supplement: MultiVitamin with Fluoride Drops by H2 Pharma

MultiVitamin with Fluoride Drops Label Images

This product contains

Below is a list of the 'active' ingredients listed on the supplement label for this product.

For a list of 'other ingredients', such as fillers, please see the 'Label Information' section on this page.

Drugs that interact with MultiVitamin with Fluoride Drops by H2 Pharma

Below is a list of drug interactions for each ingredient in this supplement product. Please note that a supplement product may contain more than one ingredient that has interactions.

Label Information

Supplement Facts:

Daily Value (DV) Target Group(s): Adults and children 4 or more years of age
Minimum serving Sizes:
1 mL
Maximum serving Sizes:
1 mL
Servings per container 50
UPC/BARCODE 361269161506

Ingredient Amount per Serving Group % DV, Adults & children 4+ years
Vitamin A
1500 IU
Vitamin A 60%
Vitamin C
35 mg
Vitamin C 88%
Vitamin D
400 IU
Vitamin D 100%
Vitamin E
5 IU
Vitamin E 50%
Thiamine
0.5 mg
Thiamin 71%
Riboflavin
0.6 mg
Riboflavin 75%
Niacinamide
8 mg
Niacin 89%
Vitamin B6
0.4 mg
Vitamin B6 57%
Vitamin B12
2 mcg
Vitamin B12 67%
Fluoride
0.25 mg
Fluoride --

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


Label Statments:


General Statements
- 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.
- A comprehensive 5-1/2 year series of studies of the effectiveness of multivitamin, iron, and fluoride drops in caries protection has been published. Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided into 2 groups, one which used only the non-fluoride vitamin product, and the other, multivitamins-fluoride products. The three year interim report showed 63% fewer carious surfaces in primary teeth and 43% fewer carious surfaces in permanent teeth of the children taking multivitamin-fluoride products. After four years, the studies continued to support the effectiveness of multivitamin-fluoride products, showing a reduction in carious surfaces of 68% in primary teeth and 46% in permanent teeth. Results at the end of the 5-1/2 years further confirmed the previous findings and indicated that significant reductions in dental caries are apparent with the continued use of multivitamin-fluoride products.
- How Supplied MultiVitamin and Fluoride Supplemental Drops 0.25 mg are available in 50 mL bottles with accompanying calibrated dropper.
- 61269-161-50 Rx
Formula
- MultiVitamin with Fluoride Supplement Drops provide supplementation of the diet with sodium fluoride and nine essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. 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. MultiVitamin and Fluoride Supplemental Drops 0.25 mg provide fluoride in drop form for infants and young children 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. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus nine essential vitamins The American Academy of Pediatrics recommends that infants and young children 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in the areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a full dose (1 mL) of MultiVitamin and Fluoride Supplemental Drops 0.25 mg. A half dose (0.5 mL) of MultiVitamin and Fluoride Supplemental Drops 0.5 mg could also provide a daily fluoride intake of 0.25 mg; however the dosage reduces vitamin supplementation by half. MultiVitamin and Fluoride Supplemental Drops 0.25 mg and MultiVitamin and Fluoride Supplemental Drops 0.5 mg supply significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacinamide, pyridoxine and cyanocobalamin 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, infants and children obtain nine essential vitamins and fluoride.
- MultiVitamin with Fluoride 0.25 mg
- Active ingredient for caries prophylaxis: Each 1 mL contains 0.25 mg fluoride as sodium fluoride.
FDA Disclaimer Statement
- 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.
Precautions
- 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.)
- 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.
- U.S. Recommended Daily Allowance not established. Consult your physician for use by infants and young children 6 months to 3 years of age.
Suggested/Recommended/Usage/Directions
- Dosage and Administration 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.
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.
FDA Statement of Identity
- Supplement Drops

Brand Information

See all products by this brand

Distributed by
Name H2-Pharma, LLC
Street Address 2010 Berry Chase Place
City Montgomery
State AL
ZipCode 36117
Web Address www.h2-pharma.com

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DISCLAIMER: Currently this does not check for drug-drug interactions. This is not an all-inclusive comprehensive list of potential interactions and is for informational purposes only. Not all interactions are known or well-reported in the scientific literature, and new interactions are continually being reported. Input is needed from a qualified healthcare provider including a pharmacist before starting any therapy. Application of clinical judgment is necessary.

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