D-VITE PEDIATRIC ORAL LIQUID- cholecalciferol solution

D-Vite Pediatric Oral Liquid by

Drug Labeling and Warnings

D-Vite Pediatric Oral Liquid 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 mL (dropperful)                                                          % Daily Value                                                                

                                                             Infants through 12 months of age      Children 1 through 4 years of age

400 IU/mL

(CHOLECALCIFEROL)                                                                        100%                                                          150%  

HEALTH CLAIM

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.

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.

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

D-VITE PEDIATRIC ORAL LIQUID 
cholecalciferol solution

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:71399-7401
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
CARAMEL (UNII: T9D99G2B1R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71399-7401-5	50 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		12/18/2019

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
flavor

Labeler - Akron Pharma (067878881)