FDA.reportPublic FDA data

NovaDHA ™ PEDIATRIC DROPS DIETARY SUPPLEMENT

Manufacturer
Gensavis Pharmaceuticals, LLC
Effective date
2016-02-01
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:12

Label at a glance#

ProductNovaDHA Baby DHA
Active ingredientOmega-3 Fatty Acids, Cholecalciferol, .Alpha.-Tocopherol
Label structure6 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Supplement Facts
SERVING SIZE 5 ml*
SERVINGS PER BOTTLE: 12
Amount Per Serving% Daily Value
* Infants under 1 year of age.
Calories45
Total Fat5.0 g†
Vitamin A230-902 IU15-61%
Vitamin D-3400 IU100%
Total Omega-3s1050 mg†
  EPA (Eicosapentaenoic Acid)350 mg†
  DHA (Docosahexaenoic Acid)485 mg†
Other Omega-3s215 mg†

* Refer to back of box for suggested use.

† Daily Value not established

OTHER INGREDIENTS: Purified arctic cod liver oil, rosemary extract (a natural preservative), D-alpha tocopherol, cholecalciferol in medium chain triglycerides.

No gluten, milk derivative or artificial colors or flavors

WARNING

WARNINGS SECTION

Consult with your physician before using this product if your child is allergic to iodine, using blood thinners, or anticipates surgery.

SAFE HANDLING WARNING SECTION

Do not use if seal is broken or missing.

SUGGESTED USE

DOSAGE & ADMINISTRATION SECTION

Shake well before use.

As a dietary supplement for infants and children ranging from 5 to 35 pounds in weight. Take as directed unless otherwise instructed by your child's physician.

HEALTH CLAIM SECTION

Distributed by:
Gensavis®
PHARMACEUTICALS LLC

Gensavis Pharmaceuticals, LLC
Corpus Christi, TX 78415

Manufactured in the USA

Questions or Comments?
Call 972-836-7783
Monday–Friday, 9:00am to 4:30pm EST
Or visit our website at
www.novaferrum.com

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NovaDHA™
PEDIATRIC DROPS
DIETARY SUPPLEMENT

omega-3
supplement

For Infants & Children
Under 4 Years of Age

2 FL OZ (60 mL)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
OMEGA-3 FATTY ACIDS Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52304-719-50NovaDHA Baby DHA60 mL in 1 BOTTLE, GLASSLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52304-719NOVADHA BABY DHA (OMEGA-3 FATTY ACIDS, CHOLECALCIFEROL, AND .ALPHA.-TOCOPHEROL) LIQUID [GENSAVIS PHARMACEUTICALS, LLC]11 package rows20160209_54d9bd6d-0d59-45af-957d-cbebd22f0918.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52304-71952304-719-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Omega-3 Fatty Acids71M78END5SACTIB
Cholecalciferol1C6V77QF41ACTIB
.Alpha.-TocopherolH4N855PNZ1ACTIB
RosemaryIJ67X351P9IACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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