FDA Label for Neonatal19
View Indications, Usage & Precautions
Neonatal19 Product Label
The following document was submitted to the FDA by the labeler of this product Slv Pharmaceuticals Llc Dba Aum Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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:
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
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.
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.
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
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
One tablet daily or as directed by a physician.
NOTICE Contact with moisture can discolor or erode the tablet. Do not chew tablet.
Storage
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
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
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