{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["WARNING 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."],"contraindications":["CONTRAINDICATIONS Folcal DHA Capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor."],"description":["DESCRIPTION Folcal DHA Capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with DHA. Each softgel capsule is brown in color, opaque, and imprinted with \"ML 350\" in white. Each softgel capsule contains: Vitamin C (ascorbic acid, USP) 25 mg Calcium (tribasic calcium phosphate, NF) 160 mg Iron (ferrous fumarate, USP) 30 mg Vitamin D 3 (cholecalciferol, USP) 170 IU Vitamin E (d-alpha tocopherol, USP) 30 IU Vitamin B 6 (pyridoxine hydrochloride, USP) 25 mg Folic Acid, USP 1.24 mg DHA (docosahexaenoic acid) 265 mg Docusate Sodium, USP 55 mg Inactive Ingredients: Ethyl vanillin, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, palm kernel oil, sodium benzoate, soybean oil, sunflower oil, titanium dioxide, yellow beeswax, water, and white ink (ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze in SD-45 alcohol, titanium dioxide)."],"description_table":["
Each softgel capsule contains:
Vitamin C (ascorbic acid, USP) 25 mg
Calcium (tribasic calcium phosphate, NF) 160 mg
Iron (ferrous fumarate, USP) 30 mg
Vitamin D3 (cholecalciferol, USP) 170 IU
Vitamin E (d-alpha tocopherol, USP) 30 IU
Vitamin B6 (pyridoxine hydrochloride, USP) 25 mg
Folic Acid, USP 1.24 mg
DHA (docosahexaenoic acid) 265 mg
Docusate Sodium, USP 55 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during, and/or after pregnancy, one softgel capsule daily or as directed by a physician."],"effective_time":"20130430","how_supplied":["HOW SUPPLIED Bottles of 30 softgel capsules (NDC 68308-350-30). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.]"],"id":"ea9767ed-c1ab-42fe-b3a1-2bc209aa745e","indications_and_usage":["INDICATIONS Folcal DHA Capsules are indicated to provide vitamin/mineral and DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Folcal DHA may be useful in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label NDC 68308-350-30 30 Capsules Folcal DHA Capsules DESCRIPTION: Folcal DHA Capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with DHA. Each softgel capsule is brown in color, opaque, and imprinted with \"ML 350\" in white. INACTIVE INGREDIENTS: Ethyl vanillin, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, palm kernel oil, sodium benzoate, soybean oil, sunflower oil, titanium dioxide, yellow beeswax, water, and white ink (ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze in SD-45 alcohol, titanium dioxide). Rx Only Midlothian LABORATORIES PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label"],"precautions":["PRECAUTION Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folic acid in doses above 1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"set_id":"ea2a08d1-9fe0-454c-9da6-ee4736ae1b53","spl_product_data_elements":["Folcal DHA ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, FERROUS FUMARATE, DOCUSATE SODIUM, DOCONEXENT, and TRIBASIC CALCIUM PHOSPHATE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID FERROUS FUMARATE FERROUS CATION DOCUSATE SODIUM DOCUSATE DOCONEXENT DOCONEXENT TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION GELATIN GLYCERIN SOYBEAN OIL SODIUM BENZOATE SUNFLOWER OIL WATER ETHYL VANILLIN LECITHIN, SOYBEAN YELLOW WAX TITANIUM DIOXIDE PALM KERNEL OIL FD&C YELLOW NO. 6 FD&C BLUE NO. 1 FD&C RED NO. 40 AMMONIA ISOPROPYL ALCOHOL BUTYL ALCOHOL PROPYLENE GLYCOL SHELLAC ALCOHOL ML;350"],"spl_unclassified_section":["Rx only Rx Prenatal Vitamin with DHA 1.24 mg Folic Acid and 265 mg DHA (key omega-3 fatty acids) Essential vitamins and minerals Gentle stool softener","CAUTION Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.","Manufactured for: Midlothian LABORATORIES Rev. 12/09"],"storage_and_handling":["KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.]"],"version":"2","warnings":["WARNING Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding."]}