FDA.reportPublic FDA data

NEONATAL VITAMIN

Manufacturer
NEOMED PHARMACEUTICAL
Effective date
2020-09-18
Label type
DIETARY SUPPLEMENT
Version
5
Source
full-release
Hydrated at
2026-06-01 02:49:44

Label at a glance#

ProductNEONATAL VITAMIN
Active ingredientVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, FERROUS FUMARATE, INOSITOL, CITRUS BIOFLAVONOIDS, CALCIUM, BORON, ZINC OXIDE
Label structure4 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

SUPPLEMENT FACTS:

Serving Size: One Tablet

Each Tablet contains:

Vitamin A (as acetate, beta carotene)

1200 mcg

Vitamin D3 (as cholecalciferol)

10 mcg

Vitamin E (as dl-alpha topcopheryl acetate )

4.6 mg

Vitamin C (Ascorbic acid )

100 mg

Vitamin B1 (as thiamine HCl)

1.5 mg

Vitamin B2 (as riboflavin)

1.7 mg

Vitamin B3 (as niacinamide)

1.8 mg

Vitamin B6 (as pyridoxine HCl)

2.6 mg

Folic acid

800 mcg

Vitamin B12 (as cyanocobalamin)

4 mcg

Iron  (as ferrous fumarate )

27 mg

Citrus bioflavonoids complex 50% bio flavonoids

2 mg

Calcium (as carbonate sulfate )

263 mg

Zinc (as zinc oxide )

25 mg

Boron (as boron citrate )

0.2 mg

Inositol

5 mg

Other Ingredients: Dibasic calcium phosphate, microcrystalline  croscarmellose sodium, stearic acid, silicon dioxide, titanium dioxide (as color), polyethylene glycol, sucrose, magnesium stearate, talc,triacetin, HPMC E15,HPMC E5/E6,FD&C RED #40 (LAKES),FD&C YELLOW # 6 (LAKE )

WARNINGS SECTION

WARNINGS

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

DOSAGE & ADMINISTRATION

As with any supplement, if you are pregnant, nursing, or taking medication, consult your doctor before use.

The safe upper limit for daily intake of folic acid is 1000 mcg (1 mg).

Do not take Prenatal with other multivitamin formulas unless recommended by your doctor.

IMPORTANT INFORMATION

Long-term intake of high levels of vitamin A (excluding that sourced from beta-carotene) may increase the risk of osteoporosis in adults. Do not take this product if taking other vitamin A supplements.

Information for Patients

Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding.

Pediatric Use

Not recommended for pediatric use.

HEALTH CLAIM SECTION

HOW SUPPLIED

NEONATAL VITAMIN ; available in bottles of 100 Tablets. 70898-105-01

SAFE HANDLING WARNING

Store at room temperature.
Avoid excessive heat above 40°C (104°F.)

QUESTIONS? COMMENTS?

Manufactured for:
NEOMED Pharmaceutical,
Hauppauge, NY-11788.

REV.:08/20

Distributed by:
AUM Pharmaceuticals,
320 Oser Ave.

Hauppauge, NY-11788.

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 Count100 Count

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70898-105-01NEONATAL VITAMIN1 in 1 PACKAGETABLET15
70898-105-01NEONATAL VITAMIN100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70898-105NEONATAL VITAMIN TABLET [NEOMED PHARMACEUTICAL]52 package rows20200919_3829e029-845e-4cd1-9d2f-2bc16bfa846b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70898-105-01EA - Each70898-105a3ae6b26-f70f-44e9-a317-fb734b2ddeae12018-09-05

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70898-10570898-105-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A81G40H8B0TACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0ACTIB
THIAMINEX66NSO3N35ACTIB
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
FERROUS FUMARATER5L488RY0QACTIM
INOSITOL4L6452S749ACTIB
CITRUS BIOFLAVONOIDSBD70459I50ACTIB
CALCIUMSY7Q814VUPACTIB
BORONN9E3X5056QACTIB
ZINC OXIDESOI2LOH54ZACTIM
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
POLYETHYLENE GLYCOL 8000Q662QK8M3BIACT
HYPROMELLOSES3NXW29V3WOIACT
TRIACETINXHX3C3X673IACT
SUCROSEC151H8M554IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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