D-VITE PEDIATRIC ORAL LIQUID- cholecalciferol solution 
Akron Pharma

----------

D-VITE
Pediatric Drops

 Supplement Facts
 Serving Size:  1 mL Daily
 Amount Per mL (dropperful)                                                          % Daily Value                                                                
                                                             Infants through 12 months of age      Children 1 through 4 years of age
400 IU                                                                        100%                                                          100%  

D-VITE Drops provides essential vitamin that helps your baby's body absorb calcium for strong bones and teeth.*

D-VITE Drops complements your breast milk to help provide optimal nutrition for your baby. *

* This statment 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

D-VITE PEDIATRIC ORAL LIQUID 
cholecalciferol solution
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71399-7401
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARAMEL (UNII: T9D99G2B1R)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:71399-7401-550 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: 3/2023
Document Id: df18a712-b23f-4d64-b428-8a71e8787ab8
Set id: f823cb3a-607c-4272-a0c1-da823dabd8e9
Version: 3
Effective Time: 20230318
 
Akron Pharma