FDA.reportPublic FDA data

NEONATAL PLUS VITAMIN prenatal/postnatal multi-vitamin/mineral tablet Rx

Manufacturer
NEOMED PHARMACEUTICAL
Effective date
2020-09-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 20:33:28

Label at a glance#

ProductNEONATAL PLUS 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, COPPER
Label structure10 sections

Boxed warning

WARNING Accidental overdose of  iron-containing  products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Dosage and administration

One tablet daily or as directed by a physician.

Label contents#

Full prescribing information#

BOXED WARNING SECTION

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

STATEMENT OF IDENTITY SECTION

Each prenatal tablet contains:

Each Tablet contains:

Vitamin A (as acetate, beta carotene)

1200 mcg

Vitamin D3 (as cholecalciferol)

10 mcg

Vitamin E (as dl-alpha topcopheryl acetate )

9.2 mg

Vitamin C (Ascorbic acid )

20 mg 

Vitamin B1 (as thiamine HCl)

1.84 mg

Vitamin B2 (as riboflavin)

3 mg

Vitamin B3 (as niacinamide)

20 mg

Vitamin B6 (as pyridoxine HCl)

10 mg

Folic acid

1000 mcg

Vitamin B12 (as cyanocobalamin)

12 mcg

Iron  (as ferrous fumarate )

27 mg

Citrus bioflavonoids complex 50% bio flavonoids

2 mg

Calcium (as carbonate sulfate )

200 mg

Zinc (as zinc oxide )

25 mg

Copper (as cupric oxide)

2 mg

Boron (as boron citrate )

0.2 mg

Inositol

5 mg

Other Ingredients: , 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 )

INDICATIONS & USAGE SECTION

NEONATAL PLUS TABLET  Rx is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS SECTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

PRECAUTIONS

PRECAUTIONS SECTION

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

To report a serious adverse event or obtain product information, call 631-524-5758

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

One tablet daily or as directed by a physician.

HOW SUPPLIED

HOW SUPPLIED SECTION

Bottles of 100 tablets each - NDC 70898-115-01

STORAGE

Store at 20-25°C (68-77°F) [See USP controlled room temperature].

To report a serious adverse event or obtain product information, call 631-524-5758

Distributed by:

Neomed Pharmaceutical ,80 Cain Dr, Brentwood,NY 11717

Phone :631-524-5758

Email: info@neomedpharmaceutical.com

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
COPPER 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
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
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
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70898-115-012022-01-28C16284748780-19d75b9d0-b5db-f424-e053-dadaa90a57ceNEONATAL PLUS VITAMIN prenatal/postnatal multi-vitamin/mineral tablet Rx
70898-115-012020-09-18C16284748780-19d75b9d0-b5db-f424-e053-dadaa90a57ceNEONATAL PLUS VITAMIN prenatal/postnatal multi-vitamin/mineral tablet Rx
70898-115-012020-01-31C16284748780-19d75b9d0-b5db-f424-e053-dadaa90a57ceNEONATAL PLUS VITAMIN prenatal/postnatal multi-vitamin/mineral tablet Rx

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70898-115-01NEONATAL PLUS VITAMIN1 in 1 PACKAGETABLET14
70898-115-01NEONATAL PLUS VITAMIN100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70898-115NEONATAL PLUS VITAMIN TABLET [NEOMED PHARMACEUTICAL]4Legacy NDC, 2 package rows20200919_d6f0af28-1e4a-4b06-9ff5-fc15f3f13ea9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70898-115-01EA - Each70898-115b5cca1b3-c0b0-4da8-9f52-2f76dfe314e112018-09-05

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70898-11570898-115-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 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
COPPER789U1901C5ACTIB
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 · Source PDF

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
65f35737-6135-4e75-a0be-02260522d5efd6f0af28-1e4a-4b06-9ff5-fc15f3f13ea92020-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 65f35737-6135-4e75-a0be-02260522d5ef
spl set id: d6f0af28-1e4a-4b06-9ff5-fc15f3f13ea9

Reported adverse events (FAERS/openFDA)#

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