NEONATAL DHA- vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet 
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS

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.

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NEONATAL DHA

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.

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

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

carton

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)

Revised: 9/2020
Document Id: 887ca9c1-9d22-4cce-9159-5613f1eb9c60
Set id: 9f3ef0af-a2b3-43a7-ad5d-3af9c4132b2a
Version: 1
Effective Time: 20200917
 
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS