Label: NEONATAL19- ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid tablet

  • 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.

  • BOXED WARNING (What is this?)

    WARNING: If you are pregnant, nursing or taking medication, consult your doctor before use. Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or Poison Control Center immediately.

  • 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

    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

  • PRINCIPAL DISPLAY PANEL

    Container Label

  • INGREDIENTS AND APPEARANCE
    NEONATAL19 
    ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:73317-8242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN150 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73317-8242-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/24/2020
    Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)
    Registrant - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)
    Establishment
    NameAddressID/FEIBusiness Operations
    SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS081225162manufacture(73317-8242)