Label: NEONATAL DHA- vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet
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Contains inactivated NDC Code(s)
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.
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- Official Label (Printer Friendly)
- BOXED WARNING (What is this?)
- KEEP OUT OF REACH OF CHILDREN
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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
- CONTRAINDICATIONS
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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
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
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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
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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 tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73317-6288 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) BETA CAROTENE 1200 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 25 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) THIAMINE 3 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 3 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1000 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 8 ug CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 29 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 15 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 3 mg BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 30 ug CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 7 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 100 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 150 ug Inactive Ingredients Ingredient Name Strength 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 Color white Score no score Shape CAPSULE Size 6mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73317-6288-6 2 in 1 CARTON 09/15/2020 1 30 in 1 BOTTLE 1 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/15/2020 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(73317-6288)