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

Poly-Vite/Iron Oral Solution by

Drug Labeling and Warnings

Poly-Vite/Iron Oral Solution by is a Other medication manufactured, distributed, or labeled by Akron Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 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)