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

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated May 28, 2024

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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

    Storage:  Store at room temperature 15º -30ºC(59º -86ºF). Protect from freezing. After opening, store away from direct light. Refrigerator is not required.

  • 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

    SHAKE WELL BEFORE USE.

  • 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

    label

    carton

  • 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 solution
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71399-7420
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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 ACID50 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.-TOCOPHEROL5 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) NIACINAMIDE4 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 CATION11 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71399-7420-550 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement01/04/2021
    Labeler - Akron Pharma (067878881)