| 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% |
| Iron | 10 mg | 100% |
| Fluoride | 0.25 mg | † |
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
% 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, Iron and Fluoride
- Brand
- H2 Pharma
- Barcode (UPC)
- 3 61269 16350 0
- Net contents
- 1.67 Fluid Ounce(s); 50 mL
- Market status
- On market
- DSLD ID
- 239693
Classification
- Supplement form
- Liquid
- Product type
- Multi-Vitamin and Mineral (MVM)
- Claim types on the label
- Nutrient, All Other, Structure/Function
- Intended for
- Infants/Baby (0 - 1 Year), Children more than 1 but less than 4
Label statements
Formula: Contains: MultiVitamin, Iron and Fluoride Supplement Drops 0.25 mg provide supplementation of the diet with iron and eight essential vitamins, as well as sodium 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, Iron and Fluoride Supplemental Drops 0.25 mg provide fluoride in drop form for children 2 to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride; and for children over 3 years, in areas where the drinking water contains 0.3 through 0.7 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus eight essential vitamins and iron. The American Academy of Pediatrics and the American Dental Association currently recommend that infants and young children under 2 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 2-3 years of age, in the areas where the drinking water contains 0.3 through 0.7 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a full dose (1 mL) of MultiVitamin, Iron and Fluoride Supplemental Drops 0.25 mg. MultiVitamin, Iron and Fluoride Supplemental Drops 0.25 mg provide significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacinamide, pyridoxine and iron to supplement the diet, and to help ensure that nutritional deficiencies of these vitamins will not develop.
Precautions: Children: Warnings As in the case of all medications, keep out of the reach of children.
Precautions: 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: 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 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.
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.
Precautions: All Other: Tamper Evident: Do not use if printed bottle seal around bottle cap is broken or missing.
FDA Statement of Identity: Supplement Drops
Precautions: Children: Consult your physician for use by infants and children 2 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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