Label: TRI-VITE PEDIATRIC ORAL SOLUTION- vitamin a palmitate, sodium ascorbate, cholecalciferol solution
- NHRIC Code(s): 71399-7504-5
- Packager: Akron Pharma
- Category: DIETARY SUPPLEMENT
Drug Label Information
Updated May 13, 2021
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- STATEMENT OF IDENTITY
- HEALTH CLAIM
- SAFE HANDLING WARNING
- WARNINGS
- PRECAUTIONS
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DOSAGE & ADMINISTRATION
Directions for use:
Administer this supplement using only the device provided. Shake bottle well and fill dropper to 1.0 ml. line. Dosage not to exceed 1.0 ml. per day unless doctor recommends another dosage. Dispense directly into mouth or mixed with formula, fruit juice, cereal or other foods. Rinse and retain device for further dosing of this product.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRI-VITE PEDIATRIC ORAL SOLUTION
vitamin a palmitate, sodium ascorbate, cholecalciferol solutionProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:71399-7504 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A .225 mg in 1 mL SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 35 mg in 1 mL CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL .01 mg in 1 mL Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) METHYLPARABEN (UNII: A2I8C7HI9T) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) CARAMEL (UNII: T9D99G2B1R) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:71399-7504-5 50 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 12/18/2019 Labeler - Akron Pharma (067878881)