Label: NEONATAL DHA- vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet

  • NDC Code(s): 73317-6288-6
  • 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 17, 2020

If you are a consumer or patient please visit this version.

  • BOXED WARNING (What is this?)

    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.

  • KEEP OUT OF REACH OF CHILDREN

  • DESCRIPTION

    Neonatal DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet and a soft gel of DHA an essential fatty acid.

    Each tablet contains:

    VITAMIN A (AS  BETA CAROTENE)

    1200 MCG

    VITAMIN C (ASCORBIC ACID)

    120 MG

    VITAMIN D3 (AS CHOLECALCIFEROL)

    25 MCG

    VITAMIN E (AS DL-ALPHA TOCOPHEROL ACETATE)

    18.4 MG

    VITAMIN B1 (AS THIAMINE MONONITRATE)

    3 MG

    VITAMIN B2 (AS RIBOFLAVIN)

    3 MG

    VITAMIN B3 (AS NIACINAMIDE)

    20 MG

    VITAMIN B6 (AS PYRIDOXINE HCL)

    3 MG

    FOLIC ACID

    1000 MCG

    VITAMIN B12 (AS CYANOCOBALAMIN)

    8 MCG

    CALCIUM (AS CALCIUM CARBONATE)

    200 MG

    IRON (AS FERROUS FUMARATE)

    29 MG

    ZINC (AS ZINC OXIDE)

    15 MG

    COPPER (AS CUPRIX OXIDE)

    3 MG

    BIOTIN

    30 MCG

    PANTOTHENIC ACID (AS CALCIUM-D- PANTOTHENATE

    7 MG

    MAGNESIUM (AS MAGNESIUM OXIDE)

    100 MG

    IODINE (AS POTASSIUM IODIDE )

    150 MCG

    Other Ingredients: microcrystalline cellulose, stearic acid, croscarmellose sodium, silicon dioxide, magnesium stearate, HPMC E15, HPMC E5/E6,titanium dioxide,PEG-8000,

                                   Each DHA soft gel contains:

    Algal oil                                                                              500 mg

    Docosahexaenoic Acid (DHA,) Algal Oil)

    200 mg

    Other ingredients in DHA soft gel: Gelatin,Glycerin,Purified water

  • INACTIVE INGREDIENT

  • PURPOSE

  • INDICATIONS

    NEONATAL DHA 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 a known hypersensitivity to any of the ingredients.

  • WARNING

    Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

    WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.

  • PRECAUTIONS

    Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

  • DOSAGE AND ADMINISTRATION

    One tablet and one capsule daily or as directed by a physician.

  • STORAGE

    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimalized.

    NOTICE: Contact with moisture can discolor or erode the tablet.

    HOW SUPPLIED

    30 Prenatal DHA Soft Gels & 30 Prenatal Vitamin  - NDC 73317-6288-6.

    To report a serious adverse event or obtain product information, call 1-866-760-6565.

    Please consult your health care provider with any dietary concerns.

    DHA soft gels manufactured for:

    Call your licensed medical practitioner about side effect.

    Manufactured for and Distributed by:

    AUM Pharmaceuticals
    Hauppauge, NY 11788.

    Made in USA

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    NEONATAL DHA 
    vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:73317-6288
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) BETA CAROTENE1200 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL25 ug
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-18.4 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE3 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN8 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION3 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID7 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION100 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION150 ug
    Inactive Ingredients
    Ingredient NameStrength
    SCHIZOCHYTRIUM DHA OIL (UNII: 2GQR19D8A4) 500 mg
    4,7,10,13,16,19-DOCOSAHEXAENOIC ACID, (4E,7E,10E,13E,16E,19E)- (UNII: ZR7NX0Z98X) 200 mg
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    TALC (UNII: 7SEV7J4R1U)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize6mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73317-6288-62 in 1 CARTON09/15/2020
    130 in 1 BOTTLE
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/15/2020
    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(73317-6288)