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

Tri-Vite Pediatric Oral Solution by

Drug Labeling and Warnings

Tri-Vite Pediatric 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 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%

HEALTH CLAIM

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.

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

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

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:71399-7504
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	.225 mg  in 1 mL
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	35 mg  in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	.01 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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARAMEL (UNII: T9D99G2B1R)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71399-7504-5	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

Labeler - Akron Pharma Inc. (067878881)