{"adverse_reactions":["Adverse Reactions Allergic sensitization has been reported following both oral and parenteral administration of folic acid. To report a serious adverse event or to obtain product information, contact (866) 703-3508."],"contraindications":["Contraindications Folet DHA is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy."],"description":["Description Folet DHA combination pack is a prescription prenatal vitamin and mineral supplementation with DHA taken through pregnancy and during the portnatal period for both lactating and non-lactating mothers. Folet DHA combination pack is also useful in improving nutritional status prior to conception. It is recommended that for all women folate levels should be high for at least one month prior to possible conception and continued at that level for the first three months of pregnancy."],"dosage_and_administration":["Dosage and Administration One tablet and one softgel daily or as direct by a physician."],"effective_time":"20140915","id":"b2ade83e-2dee-43e2-be8f-2e0a39057bba","openfda":{},"package_label_principal_display_panel":["FoletDHA"],"set_id":"19df5244-1a40-4f9e-af28-e2a90d996566","spl_product_data_elements":["Folet DHA DHA (docosahexaenoic acid), Vit.A (beta-carotine), Vit.C (ascorbic acid), Vit.D-3 (cholecalciferol), Vit.E (d-alpha-tocopheryl acetate), Vit.B-1 (thiamine HCl), Vit.B-2 (riboflavin), Vit.B-3 (niacinamide), Vit.B-6 (pyridoxine HCl), Folate (1.85 mg (6S)-5-methyltetrahydrofolate-Quatrefolic), Vit.B-12 (cyanocobalamin), Iron (carbonyl iron -Ferronyl and ferrous bis-glycinate chelate -Ferrochel), Magnesium (magnesium oxide), Zinc (zinc bis-glycinate chelate -TRAACS), Selenium (sodium selenate), Docusate Sodium Folet DHA Vit.A (beta-carotine), Vit.C (ascorbic acid), Vit.D-3 (cholecalciferol), Vit.E (d-alpha-tocopheryl acetate), Vit.B-1 (thiamine HCl), Vit.B-2 (riboflavin), Vit.B-3 (niacinamide), Vit.B-6 (pyridoxine HCl), Folate (1.85 mg (6S)-5-methyltetrahydrofolate-Quatrefolic), Vit.B-12 (cyanocobalamin), Iron (carbonyl iron -Ferronyl and ferrous bis-glycinate chelate -Ferrochel), Magnesium (magnesium oxide), Zinc (zinc bis-glycinate chelate -TRAACS), Selenium (sodium selenate), Docusate Sodium BETA CAROTENE .BETA.-CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, D- .ALPHA.-TOCOPHEROL, D- THIAMINE HYDROCHLORIDE THIAMINE ION RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN FERROUS BISGLYCINATE FERROUS CATION MAGNESIUM OXIDE MAGNESIUM CATION ZINC GLYCINATE ZINC CATION SELENIUM SELENIUM DOCUSATE SODIUM DOCUSATE CELLULOSE, MICROCRYSTALLINE METHACRYLIC ACID CROSCARMELLOSE SODIUM GELATIN SHELLAC HYPROMELLOSES STEARIC ACID CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CROSPOVIDONE TALC SODIUM BENZOATE SILICON DIOXIDE STARCH, CORN TRIACETIN TITANIUM DIOXIDE CITRIC ACID MONOHYDRATE SODIUM LAURYL SULFATE MAGNESIUM STEARATE SOYBEAN POVIDONE MINERAL OIL FD&C RED NO. 40 FD&C BLUE NO. 2 POLYETHYLENE GLYCOLS SODIUM ASCORBATE TOCOPHEROL TRICALCIUM PHOSPHATE C10-18 TRIGLYCERIDES GLYCERYL MONOSTEARATE TRIETHYL CITRATE SORBIC ACID ASCORBYL PALMITATE POLYSORBATE 80 METHYLPARABEN PROPYLPARABEN FOLET Folet DHA Docosahexaenoic Acid (DHA) DOCONEXENT DOCONEXENT GELATIN GLYCERIN METHACRYLIC ACID WATER POLYETHYLENE GLYCOLS TALC HYPROMELLOSES MINERAL OIL"],"version":"1","warnings_and_cautions":["Warnings and Precautions WARNINGS: 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. PRECAUTIONS: Folic Acid alone in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia. Ingestion of more than 3 grams per day of omega-3 fatty acids, such as DHA (docosahexaenoic acid) has been shown to have potential anti-thrombotic effects, including increased bleedng times. Administration of Folet DHA Omega-3 Fatty Acids should be avoided in patients taking anticoagulants."]}