NEONATAL Complete

Manufacturer
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
Effective date
2020-09-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:14:59

Label at a glance#

ProductNEONATAL Complete
Active ingredientBETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE, BIOTIN, CALCIUM PANTOTHENATE, MAGNESIUM OXIDE, POTASSIUM IODIDE
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 and one capsule daily or as directed by a physician.

Storage and handling

Store at 15°C to 30°C (69°F to 86°F). [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container. NOTICE:  Contact with moisture may produce surface discoloration or erosion of tablet. 100 Prenatal Vitamin Tablets  -  NDC  73317-8286-1. To report  a serious adverse event or obtain product information, call 1-866-760-6565. Please consult  your health care ...

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.

DESCRIPTION

OTC - ACTIVE INGREDIENT SECTION

Each tablet contains:

VITAMIN A (AS  BETA CAROTENE)

1200 MCG

VITAMIN C (ASCORBIC ACID)

120 MG

VITAMIN D3 (AS CHOLECALCIFEROL)

25 MCG

VITAMIN E (AS DL-ALPHA TOCOPHEROL ACETATE)

18.4 MG

VITAMIN B1 (AS THIAMINE MONONITRATE)

3 MG

VITAMIN B2 (AS RIBOFLAVIN)

3 MG

VITAMIN B3 (AS NIACINAMIDE)

20 MG

VITAMIN B6 (AS PYRIDOXINE HCL)

3 MG

FOLIC ACID

1000 MCG

VITAMIN B12 (AS CYANOCOBALAMIN)

8 MCG

CALCIUM (AS CALCIUM CARBONATE)

200 MG

IRON (AS FERROUS FUMARATE)

29 MG

ZINC (AS ZINC OXIDE)

15 MG

COPPER (AS CUPRIX OXIDE)

3 MG

BIOTIN

30 MCG

PANTOTHENIC ACID (AS CALCIUM-D- PANTOTHENATE

7 MG

MAGNESIUM (AS MAGNESIUM OXIDE)

100 MG

IODINE (AS POTASSIUM IODIDE )

150 MCG

Other Ingredients: microcrystalline cellulose, stearic acid, croscarmellose sodium, silicon dioxide, magnesium stearate, HPMC E15, HPMC E5/E6,titanium dioxide,PEG-8000, Talc.

INDICATIONS

INDICATIONS & USAGE SECTION

NEONATAL Complete 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

CONTRAINDICATIONS SECTION

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

WARNING

WARNINGS SECTION

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

One tablet and one capsule daily or as directed by a physician.

STORAGE

STORAGE AND HANDLING SECTION

Store at 15°C to 30°C (69°F to 86°F). [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.

NOTICE: Contact with moisture may produce surface discoloration or erosion of tablet.

HOW SUPPLIED

HOW SUPPLIED SECTION

100 Prenatal Vitamin Tablets  - NDC 73317-8286-1.

To report a serious adverse event or obtain product information, call 1-866-760-6565.

Please consult your health care provider with any dietary concerns.

Call your licensed medical practitioner about side effect.

Manufactured for and Distributed by:

AUM Pharmaceuticals
Hauppauge, NY 11788.

Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73317-8286-12024-09-05C16284748780-1f386c649-ebda-0266-e053-dadaa90a7c1aNEONATAL COMPLETE
73317-8286-12023-01-30C16284748780-1f386c649-ebda-0266-e053-dadaa90a7c1aNEONATAL COMPLETE

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73317-8286-1EA - Each73317-8286f613fc4f-59e6-4fd9-bea7-28a5986ebf4812024-05-16

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73317-828673317-8286-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fd02433c-4a26-4bae-9207-0523752ef82b6bc434a5-041a-42b5-84a8-3ab0814cd5452024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 6bc434a5-041a-42b5-84a8-3ab0814cd545

Reported adverse events (FAERS/openFDA)#

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