TRI-VITE PEDIATRIC ORAL SOLUTION- vitamin a palmitate, sodium ascorbate, cholecalciferol solution 
Akron Pharma

----------

TRI-VITE
Pediatric Drops

                                                                                            Supplement Facts

 Serving size:  1 mL Daily
 Serving per container:  50
 Amount per 1mL (dropperful)                                                                           % Daily Value
                                                                         Infants through 12 Months of age            Children 1 through 4 Years of age
 Vitamin A     225 mcg                                                               50%                                                             30%
 Vitamin C      35 mg                                                               100%                                                              88%
 Vitamin D      10 mcg                                                             100%                                                            100%

TRI-VITE Drops is designed to help meet the nutritional needs of your growing infant.*

* 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.

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.

image description

image description

TRI-VITE PEDIATRIC ORAL SOLUTION 
vitamin a palmitate, sodium ascorbate, cholecalciferol solution
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71399-7504
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 ACID35 mg  in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL.01 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)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CARAMEL (UNII: T9D99G2B1R)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:71399-7504-550 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement12/18/2019
Labeler - Akron Pharma (067878881)

Revised: 5/2021
Document Id: b2515d6c-5f61-4d7c-9db8-653c95b8e617
Set id: 2f9c87dd-54b1-41e7-b198-64bc12c1288b
Version: 1
Effective Time: 20210513
 
Akron Pharma