DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. One tablet and one capsule daily or as directed by physician.
HOW SUPPLIED SECTION.
HOW SUPPLIED. 30 Prenatal DHA Soft Gels 30 Prenatal Vitamin NDC 73317-6288-6.To report 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.
INDICATIONS & USAGE SECTION.
INDICATIONS. NEONATAL DHA is 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.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS. Allergicsensitization has been reported following both oral and parenteraladministration of folic acid.
BOXED WARNING SECTION.
WARNING: Accidental overdose of iron-containing products is aleading cause of fatal poisoning in children under 6. KEEP THIS PRODUCTOUT OF THE REACH OF CHILDREN. In case of accidental overdose, calla doctor or poison control center immediately.
CONTRAINDICATIONS. This product is contraindicated in patients witha known hypersensitivity to any of the ingredients.
OTC - ACTIVE INGREDIENT SECTION.
DESCRIPTION. Neonatal DHA is prescription prenatal/postnatal multi-vitamin/mineral tablet and soft gel of DHA an essential fatty acid.Each tablet contains:VITAMIN (AS BETA CAROTENE)1200 MCGVITAMIN (ASCORBIC ACID)120 MGVITAMIN D3 (AS CHOLECALCIFEROL)25 MCGVITAMIN (AS DL-ALPHA TOCOPHEROL ACETATE)18.4 MGVITAMIN B1 (AS THIAMINE MONONITRATE)3 MGVITAMIN B2 (AS RIBOFLAVIN)3 MGVITAMIN B3 (AS NIACINAMIDE)20 MGVITAMIN B6 (AS PYRIDOXINE HCL)3 MGFOLIC ACID1000 MCGVITAMIN B12 (AS CYANOCOBALAMIN)8 MCGCALCIUM (AS CALCIUM CARBONATE)200 MGIRON (AS FERROUS FUMARATE)29 MGZINC (AS ZINC OXIDE)15 MGCOPPER (AS CUPRIX OXIDE)3 MGBIOTIN30 MCGPANTOTHENIC ACID (AS CALCIUM-D- PANTOTHENATE7 MGMAGNESIUM (AS MAGNESIUM OXIDE)100 MGIODINE (AS POTASSIUM IODIDE )150 MCGOther 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 mgDocosahexaenoic Acid (DHA,) Algal Oil)200 mgOther ingredients in DHA soft gel: Gelatin,Glycerin,Purified water.
PRECAUTIONS. Folic acid in doses above 0.1 mg daily may obscurepernicious anemia in that hematologic remission can occur while neurologicalmanifestations progress.
STORAGE AND HANDLING SECTION.
STORAGE. Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (between 59F and 86F). Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinetic temperature does not exceed 25C (77F); 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 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.
WARNING. Ingestion of more than grams of omega-3 fattyacids per day has been shown to have potential antithrombotic effects,including an increased bleeding time and INR. Administration of omega-3fatty acids should be avoided in patients on anticoagulants and inthose known to have an inherited or acquired bleeding diathesis.WARNING: Folic acidalone is improper therapy in the treatment of pernicious anemia andother megaloblastic anemias where vitamin 12 is deficient.