FDA.reportPublic FDA data

NovaFerrum ® PEDIATRIC DROPS DIETARY SUPPLEMENT

Manufacturer
Gensavis Pharmaceuticals, LLC
Effective date
2019-08-14
Label type
DIETARY SUPPLEMENT
Version
4
Source
full-release
Hydrated at
2026-06-01 02:49:20

Label at a glance#

ProductNovaFerrum Multivitamin with Iron Pediatric Drops
Active ingredientIron, Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine
Label structure6 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size: 1 mL
Servings Per Container: 50
Amount Per Serving% Daily Value
Infants Under 12 MonthsChildren Under 4 Years
Vitamin A 1500 IU100%60%
Vitamin C 35 mg100%88%
Vitamin D 400 IU100%100%
Vitamin E 5 IU100%50%
Thiamin 0.5 mg100%71%
Riboflavin 0.6 mg100%75%
Niacin 8 mg100%89%
Vitamin B6 0.4 mg100%57%
Iron 10 mg  67%100%

OTHER INGREDIENTS: Natural Vegetable Glycerin, Water, Organic Rice Bran Extract, Natural Flavor, Citric Acid, Xanthan Gum, Natural Color, Lo Han (Monk Fruit) Extract, Sorbic Acid, Benzoic Acid, Talin (Thaumatin From Katemfe Fruit)

SUGGESTED USE

DOSAGE & ADMINISTRATION SECTION

Shake well before use.

As a dietary supplement for infants and children under 4 years of age: 1 mL dropper daily unless otherwise directed by physician.

WARNINGS SECTION

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product our of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

SAFE HANDLING WARNING SECTION

Do not use if seal is broken or missing.

STATEMENT OF IDENTITY SECTION

Distributed by:
Gensavis Pharmaceuticals, LLC
Corpus Christi, TX 78415
Call 972-836-7783
www.novaferrum.com
MANUFACTURED IN THE USA

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NovaFerrum®
PEDIATRIC DROPS
DIETARY SUPPLEMENT

multivitamin
WITH IRON

KOSHER

Great
tasting!
Raspberry
Grape Flavor

For Infants & Children
Under 4 Years of Age

1⅔ FL OZ (50mL)

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NIACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
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
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52304-716-50NovaFerrum Multivitamin with Iron Pediatric Drops50 mL in 1 BOTTLE, PLASTICLIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52304-716NOVAFERRUM MULTIVITAMIN WITH IRON PEDIATRIC DROPS (IRON, VITAMIN A, ASCORBIC ACID, VITAMIN D, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACIN, AND PYRIDOXINE) LIQUID [GENSAVIS PHARMACEUTICALS, LLC]41 package rows20190816_516d759f-a304-431b-8da5-64c292de88e2.zip

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
52304-71652304-716-50

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
IronE1UOL152H7ACTIB
Vitamin A81G40H8B0TACTIB
Ascorbic AcidPQ6CK8PD0RACTIB
Vitamin D9VU1KI44GPACTIB
.Alpha.-TocopherolH4N855PNZ1ACTIB
ThiamineX66NSO3N35ACTIB
RiboflavinTLM2976OFRACTIB
Niacin2679MF687AACTIB
PyridoxineKV2JZ1BI6ZACTIB
Water059QF0KO0RIACT
Citric Acid Monohydrate2968PHW8QPIACT
Xanthan GumTTV12P4NEEIACT
Siraitia Grosvenorii FruitNOU2FB51TWIACT
Sorbic AcidX045WJ989BIACT
Benzoic Acid8SKN0B0MIMIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REAL SUMMERIRONKAYONE63021d49-8720-4e4e-a08f-a5d2f6acfaa52024-12-09WarningsName fallback
generic name: IRON
Ferrum Metallicum 6XIRONTrue Botanica, LLC2392929c-996b-01e0-e063-6394a90aa2b92024-10-03WarningsName fallback
generic name: IRON
Ferrum metallicumIRONBoiron85914cb4-f903-80c6-e053-2a91aa0ae14a2023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron85912948-19cc-76be-e053-2991aa0a3e5a2023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron8591b12c-51c8-9839-e053-2a91aa0aa9372023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron85917340-1f94-08db-e053-2a91aa0a77c92023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron87372ec7-eacf-90b1-e053-2a91aa0afadf2023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron859195ed-0b6c-f4fe-e053-2991aa0ad85b2023-03-03Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron85919b82-39cf-254d-e053-2a91aa0a61502023-02-20Name fallback
generic name: IRON

Reported adverse events (FAERS/openFDA)#

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