Neonatal 19: Package Insert / Prescribing Info

DESCRIPTION

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:

Inactive ingredients:

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

Indications and Usage for Neonatal 19

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

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

Warnings

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

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/Side Effects

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.

Neonatal 19 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.