Poly-Vite Pediatric Oral Solution

Manufacturer
Akron Pharma
Effective date
2025-02-24
Label type
DIETARY SUPPLEMENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:51:29

Label at a glance#

ProductPoly-Vite Pediatric Oral Solution
Active ingredientVITAMIN A PALMITATE, SODIUM ASCORBATE, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5'-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN
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 1 mL (dropperful)                                                                        % Daily Value
                                                                      Infants through 12 Months of age            Children 1 through 4 Years of age
Vitamin A              250 mcg                                                       56%                                                 33%
Vitamin C               50 mg                                                       143%                                                125%
Vitamin D3            10 mcg                                                       100%                                                100%
Vitamin E               5 mg                                                         100%                                                 50%  
Thiamin               0.3 mg                                                          60%                                                 43% 
Riboflavin            0.4 mg                                                          67%                                                 50%
Niacin                    4 mg                                                          50%                                                  45%
Vitamin B6           0.3 mg                                                         75%                                                   43%
Vitamin B12         0.5 mcg                                                        25%                                                   17%

HEALTH CLAIM SECTION

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

POLY-VITE Drops is an ideal multivitamin supplement during your child's transition to solid foods, during growth spurts, or for the picky eater.

* 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
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
RIBOFLAVIN 5'-PHOSPHATE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230420
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-7440-5Poly-Vite Pediatric Oral Solution50 mL in 1 BOTTLE, DROPPERSOLUTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-7440POLY-VITE PEDIATRIC ORAL SOLUTION (VITAMIN A PALMITATE, SODIUM ASCORBATE, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE,THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN) SOLUTION [AKRON PHARMA]31 package rows20250302_4747740d-867b-48af-8814-8f2252ec0cb7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-7440-5ML - Milliliter71399-744046c7658b-4a90-4503-8171-b253784e1f5612021-08-05

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-744071399-7440-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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