| Vitamin A | 1,500 IU | 100% |
| Vitamin C | 35 mg | 100% |
| Vitamin D | 400 IU | 100% |
| Iron | 10 mg | 67% |
| Fluoride | 0.25 mg | † |
Other ingredients: Each 1 ml contains
% Daily Values for: Infants; Children less than 4 years of age.
Where this label comes from
An original label of the NIH's Dietary Supplement Label Database, entered there on 21 November 2020, shown here as it was entered. The NIH's record
General information
- Product name
- Tri-Vit With Fluoride 0.25 mg and Iron Drops
- Brand
- Qualitest
- Barcode (UPC)
- 3 0603-1785-47 4
- Net contents
- 50 mL; 1.6907 fl. Oz.
- Market status
- On market
- DSLD ID
- 240148
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
FDA Statement of Identity: Vitamin A, D, C, Fluoride & iron Supplement Drops
Precautions: All Other: Do not use if tamper-evident seal under cap is broken or missing
Formula: Contains: Active ingredient for caries prophylaxis: Each 1 mL contains 0.25 mg fluoride as sodium fluoride.
Directions: See box for dosage information and complete listings of ingredients. Save box for future use. Dispense in original container.
Precautions: Children: Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Directions: Indications and Usage: Tri-Vit with Flouride 0.25 mg drops may be useful for infants whose diets are lacking in vitamins A, D and C. Tri-Vit with Flouride 0.25 mg drops also provide fluoride for caries prophylaxis. Tri-Vit with Flouride 0.25 mg (vitamins A, D, C, and fluoride) drops were developed to provide fluoride in drop form for infants and young children from 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 to 6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.
Precautions: All Other: Precautions: The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Precautions: All Other: When prescribing Tri-Vit with Fluoride 0.25 mg drops: 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 the child does not develop significant dental fluorosis.
Directions: Tri-Vit with Fluoride 0.25 mg drops 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 and other idiosyncrasies have been rarely reported.
Directions: Dosage and Administration: 1 mL daily, or as prescribed. May be dropped directly into mouth with dropper, or mixed with fruit juice, cereal or other food. Use full dosage. Dispense in original container
Precautions: All Other: While taking drops with iron, a slight darkening of the teeth may occur. Brushing will minimize this temporary condition.
Storage: After opening, store away from direct light.
Brand information
Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL
More labels from Qualitest
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