NEONATAL19

Manufacturer
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
Effective date
2020-09-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:14:07

Label at a glance#

ProductNEONATAL19
Active ingredientASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE
Label structure9 sections

Dosage and administration

One tablet daily or as directed by a physician. NOTICE Contact with moisture can discolor or erode the tablet. Do not chew tablet.

Storage and handling

Store at 20°-25°C (66°-77°F); excursions permitted to  15°-30°C (59°-86°F) [See USP Controlled Room  Temperature.] Protect from heat, light and moisture. Bottles of 100 tablets each - NDC 73317-8242-1 To report a serious adverse event or obtain product information, call (866)-760-6565 Call your licensed medical practitioner about side effect. You may report side effects by calling AUM 866-760-6565. Distributed by:...

Label contents#

Full prescribing information#

DESCRIPTION

OTC - ACTIVE INGREDIENT SECTION

NEONATAL 19 is a prescription prenatal vitamin with folic acid. Other vitamins and minerals for nutritional supplementation NEONATAL 19 is a small, round, tablet

Each tablet contains:

Vitamin C (Ascorbic Acid)

    100 mg

Vitamin B1 (Thiamine)

    1.5 mg

Vitamin B2 (Riboflavin)

    1.7 mg

Vitamin B3 (Niacinamide)

    20 mg

Vitamin B6 (Pyridoxine HCl)

    10 mg

Folic Acid

    1000 mcg

Vitamin B12 (Cyanocobalamin)

    6 mcg

Biotin

    150 mcg

Pantothenic Acid

    5 mg

Inactive ingredients:

Microcrystalline Cellulose, Di Calcium Phosphate, Stearic Acid, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide, Opadry II Yellow (color).

INDICATIONS

INDICATIONS & USAGE SECTION

NEONATAL 19 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 known hypersensitivity to any of the ingredients.

WARNING

WARNINGS SECTION

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.

PRECAUTIONS

PRECAUTIONS SECTION

Folic Acid 

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.

Pediatric Use 

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use 

Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DRUG INTERACTIONS 

Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

OVERDOSAGE 

Symptoms: abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrohosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

One tablet daily or as directed by a physician.
NOTICE Contact with moisture can discolor or erode the tablet. Do not chew tablet.

STORAGE

STORAGE AND HANDLING SECTION

Store at 20°-25°C (66°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room  Temperature.] Protect from heat, light and moisture.

HOW SUPPLIED

HOW SUPPLIED SECTION

Bottles of 100 tablets each - NDC 73317-8242-1

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


Call your licensed medical practitioner about side effect.

You may report side effects by calling AUM 866-760-6565.

Distributed by:

AUM Pharmaceuticals
Hauppauge, NY 11788.

Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container LabelContainer Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73317-8242-12024-09-05C16284748780-1f386c64a-44b8-0266-e053-dadaa90a7c1aNEONATAL 19
73317-8242-12023-01-30C16284748780-1f386c64a-44b8-0266-e053-dadaa90a7c1aNEONATAL 19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73317-8242-1EA - Each73317-8242dd16b473-0903-4965-a9c0-01d0831f2a7b12024-05-16

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73317-824273317-8242-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
de1d4fa9-c434-4db5-a136-7f7d02282a1f8c3737b7-7795-4eca-9684-8ec755a8b5942024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 8c3737b7-7795-4eca-9684-8ec755a8b594

Reported adverse events (FAERS/openFDA)#

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