Tri-Vite Pediatric Oral Solution

Manufacturer
Akron Pharma Inc.
Effective date
2025-05-05
Label type
DIETARY SUPPLEMENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:51:36

Label at a glance#

ProductTri-Vite Pediatric Oral Solution
Active ingredientVITAMIN A PALMITATE, SODIUM ASCORBATE, CHOLECALCIFEROL
Label structure7 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

                                                                                            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 SECTION

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 SECTION

Storage:  Store at room temperature 15º-30ºC(59º-86ºF).  Protect from freezing.  After opening, store away from direct light.  Refrigerator is not required.

WARNINGS SECTION

WARNING:  As with medicine, Keep out of reach of children.

PRECAUTIONS SECTION

SHAKE WELL BEFORE USE.

DOSAGE & ADMINISTRATION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

cartoncarton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-7504-5Tri-Vite Pediatric Oral Solution50 mL in 1 BOTTLE, DROPPERSOLUTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-7504TRI-VITE PEDIATRIC ORAL SOLUTION (VITAMIN A PALMITATE, SODIUM ASCORBATE, CHOLECALCIFEROL) SOLUTION [AKRON PHARMA INC.]31 package rows20250507_2f9c87dd-54b1-41e7-b198-64bc12c1288b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-7504-5ML - Milliliter71399-750431496c71-1fb4-4e1c-bf3b-6d039814e91b12021-06-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-750471399-7504-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.