{"effective_time":"20140701","id":"fb5ae915-5d9b-49ef-b9bf-e6c3198681fb","openfda":{},"package_label_principal_display_panel":["FoletOnelabel"],"set_id":"fa8470fb-6e36-4c5a-8b44-cc9965638bb5","spl_product_data_elements":["Folet One Vitamin C, Vitamin D, Vitamine E, Vitamine B6, Folate, Vitamine B12, Iron, Zinc, Magnesium, Docusate Sodium, DHA ASCORBIC ACID ASCORBIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CHOLECALCIFEROL CHOLECALCIFEROL IRON IRON MAGNESIUM MAGNESIUM ZINC ZINC DOCUSATE SODIUM DOCUSATE .ALPHA.-TOCOPHEROL, D- .ALPHA.-TOCOPHEROL, D- PYRIDOXINE HYDROCHLORIDE PYRIDOXINE DOCONEXENT DOCONEXENT GELATIN GLYCERIN SOY PROTEIN WATER WHITE WAX TITANIUM DIOXIDE FD&C RED NO. 40 FD&C BLUE NO. 1 none"],"spl_unclassified_section":["Serving Size: 1 softgel Servings per container: 30 Amount per Serving %Daily Value Vitamin C 18 mg 30% Vitamin D 250 IU 63% Vitamin E 15 IU 50% Vitamin B6 30 mg 2500% Folate 1 mg 125% Vitamin B-12 15 mcg 250% Iron 38 mg 194% Zinc 20 mg 334% Magnesium 15 mg 4% Docusate Sodium 25 mg * DHA 225 mg *","Description Folet One is a prescription prenatal vitamin and mineral supplementation with DHA taken throughout pregnancy and during the postnatal period for both lactating and non-lactating mother. Folet One 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. This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.","Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDRE. In case of accidental overdose, call a doctor or poison control center immediately.","Do Not Use Do not use Folet One for individuals with a known hypersensitivity to any of the ingredients. Patients with hemochromatosis and hemosiderosis. The product is not for use in children under 12 years of age.","Caution: This product contains 1 mg folic acid, the maximum safe Reference Daily Intake (RDI) amount for this nutrient. Folic Acid alone should not be used for individuals with pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient. Folic acid in amounts above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. 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 bleeding times. Adminitration of Folet One should be avoided in patients taking anticoagulants.","Adverse Reactions Allergic sensitization has been reported following both oral and parenteral adminitration of folic acid.","Directions for use: One softgel daily with or without food or as recommended by your healthcare provider.","Other Information: Folet One is supplied in child-resistant trade bottles of 30 softgels and sample bottles of 4 softgels. Optimum storage condition= 30 to 40% relative humidity and 59 to 86 degrees F (15-30 degrees C). Protect from extreme temperature. Freezing and excessive heat may damage softgels."],"version":"1"}