Label: NEONATAL19- ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 73317-8242-1 - Packager: SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated September 24, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- BOXED WARNING (What is this?)
-
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).
- INACTIVE INGREDIENT
- PURPOSE
- INDICATIONS
- CONTRAINDICATIONS
- WARNING
-
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
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NEONATAL19
ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73317-8242 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.5 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.7 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 10 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1000 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 6 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 150 ug CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 5 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) OPADRY YS-1-12726A YELLOW (UNII: PLG7GLN7QI) Product Characteristics Color yellow Score no score Shape ROUND Size 11mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73317-8242-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/24/2020 Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162) Registrant - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162) Establishment Name Address ID/FEI Business Operations SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS 081225162 manufacture(73317-8242)