FDA Label for Neonatal Dha
View Indications, Usage & Precautions
Neonatal Dha Product Label
The following document was submitted to the FDA by the labeler of this product Slv Pharmaceuticals Llc Dba Aum Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.