MultiVitamin with Fluoride
MultiVitamin with Fluoride Chewable Tablets
19b2baaa-04d5-465a-9c0c-7034117d7f16
DIETARY SUPPLEMENT
Sep 16, 2025
H2-Pharma, LLC
DUNS: 028473634
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, and SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (19)
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, and SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (19)
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, and SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (19)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label
61269-157-01
MultiVitamin
with Fluoride
Chewable Tablets
1 mg
MultiVitamin and Fluoride Supplement
Dietary Supplement
Orange Flavor
100 Tablets
H2 pharma
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
One tablet daily or as directed by a physician.
STATEMENT OF IDENTITY SECTION
Supplement Facts | ||
---|---|---|
Serving Size 1 Tablet | ||
Servings Per Container 100 | ||
Amount Per Serving |
% Daily Value | |
| ||
Vitamin A |
750 mcg (2500 IU) |
83% |
Vitamin C |
60 mg |
67% |
Vitamin D |
10 mcg (400 IU) |
50% |
Vitamin E |
6.75 mg (15 IU) |
45% |
Thiamine |
1.05 mg |
88% |
Riboflavin |
1.2 mg |
92% |
Niacinamide |
13.5 mg |
84% |
Vitamin B6 |
1.05 mg |
62% |
Folate (Folic Acid) |
500 mcg DFE (0.3 mg) |
125% |
Vitamin B12 |
4.5 mcg |
188% |
Fluoride |
0.25 mg |
|
WARNINGS SECTION
WARNINGS
AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN. This tablet should be chewed. This product, as with all chewable tablets, are not recommended for children under the age of 4 due to risk of choking.
HEALTH CLAIM SECTION
Distributed by:
H2-Pharma, LLC
Montgomery, AL 36117
PRECAUTIONS SECTION
PRECAUTIONS
The suggested dose ofMultiVitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before recommendingMultiVitamin with Fluoride Chewable Tablets
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 that the child does not develop significant dental fluorosis.