| Vitamin A | 1,500 IU | 60% |
| Vitamin C | 35 mg | 88% |
| Vitamin D | 400 IU | 100% |
| Vitamin E | 5 IU | 50% |
| Thiamine | 0.5 mg | 71% |
| Riboflavin | 0.6 mg | 75% |
| Niacinamide | 8 mg | 89% |
| Vitamin B6 | 0.4 mg | 57% |
| Vitamin B12 | 2 mcg | 67% |
| Fluoride | 0.25 mg | † |
Other ingredients: Ascorbic Acid, Caramel color, Cholecalciferol, Citric Acid, Cyanocobalamin, 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
% Daily Values for: Adults and children 4 or more years of age.
Where this label comes from
An original label of the NIH's Dietary Supplement Label Database, entered there on 26 December 2020, shown here as it was entered. The NIH's record
General information
- Product name
- MultiVitamin with Fluoride Drops
- Brand
- H2 Pharma
- Barcode (UPC)
- 3 61269 16150 6
- Net contents
- 1.67 Fluid Ounce(s); 50 mL
- Market status
- On market
- DSLD ID
- 239696
Classification
- Supplement form
- Liquid
- Product type
- Multi-Vitamin and Mineral (MVM)
- Claim types on the label
- Nutrient, All Other, Structure/Function
- Intended for
- Children 4 or More Years of Age, Infants/Baby (0 - 1 Year), Children more than 1 but less than 4
Label statements
Formula: Contains: 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.
Precautions: Children: Warnings As in the case of all medications, keep out of the reach of children.
Precautions: All Other: 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: All Other: 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: All Other: 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.
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.
Formula: Contains: MultiVitamin with Fluoride 0.25 mg
FDA Statement of Identity: Supplement Drops
Precautions: Children: U.S. Recommended Daily Allowance not established. Consult your physician for use by infants and young children 6 months to 3 years of age.
Formula: Contains: Active ingredient for caries prophylaxis: Each 1 mL contains 0.25 mg fluoride as sodium fluoride.
Brand information
Distributed by: H2-Pharma, LLC, Montgomery, AL
More labels from H2 Pharma
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