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 
Akron Pharma

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POLY-VITE With IRON
Pediatric Drops

                                                                                             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%

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.

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

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.

SHAKE WELL BEFORE USE.

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.

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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)

Revised: 5/2021
Document Id: c9b355ab-9a55-4921-a802-764e34fc365e
Set id: b70c629e-abef-4d1b-a78a-29aec5c123d6
Version: 1
Effective Time: 20210513
 
Akron Pharma