Label: POLY-VITE/IRON ORAL SOLUTION- vitamin a palmitate, sodium ascorbate, cholecalciferol, alpha-tocopherol acetate,thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin, ferrous sulfate solution
- NHRIC Code(s): 71399-7420-5
- Packager: Akron Pharma
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated May 13, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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STATEMENT OF IDENTITY
Supplement Facts Serving size: 1 mL Daily Serving per container: 50 Amount per 1 mL (dropperful) % Daily Value Infants through 12 Months of age Children 1 through 4 Years of age Vitamin A 250 mcg 56% 33% Vitamin C 50 mg 143% 125% Vitamin D3 10 mcg 100% 100% Vitamin E 5 mg 100% 50% Thiamin 0.3 mg 60% 43% Riboflavin 0.4 mg 67% 50% Niacin 4 mg 50% 45% Vitamin B6 0.3 mg 75% 43% Vitamin B12 0.5 mg 25% 17% Iron 11 mg 74% 110% -
HEALTH CLAIM
POLY-VITE Drops with IRON is designed to help meet the nutritional needs of your growing infant or toddler.*
POLY-VITE Drops with IRON is an ideal multivitamin supplement during your child's transition to solid foods, during growth spurts, or for the picky eater.
* This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
- SAFE HANDLING WARNING
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WARNINGS
WARNING: As with medicine, Keep out of reach of 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.
- 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
POLY-VITE/IRON ORAL SOLUTION
vitamin a palmitate, sodium ascorbate, cholecalciferol, alpha-tocopherol acetate,thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin, ferrous sulfate solutionProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:71399-7420 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 .25 mg in 1 mL SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 50 mg in 1 mL CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL .01 mg in 1 mL ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 5 mg in 1 mL THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE .3 mg in 1 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E) FLAVIN MONONUCLEOTIDE .4 mg in 1 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 4 mg in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE .3 mg in 1 mL CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN .5 mg in 1 mL FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 11 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) SACCHARIN SODIUM (UNII: SB8ZUX40TY) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) CARAMEL (UNII: T9D99G2B1R) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:71399-7420-5 50 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 01/04/2021 Labeler - Akron Pharma (067878881)
