{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"contraindications":["CONTRAINDICATIONS Folivane™-PRx DHA NF capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor."],"description":["DESCRIPTION Folivane™-PRx DHA NF capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. Each softgel capsule is oblong, maroon and imprinted with \"T544\" in white ink. * From approximately 350 mg of Omegas derived from approximately 380 mg of purified fish oil. 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 Inactive Ingredients Gelatin, Glycerin, Soybean Oil, Purified Water, Lecithin, Natural Creamy Orange Flavor, Yellow Beeswax, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, FD&C Blue #1."],"description_table":["
*From approximately 350 mg of Omegas derived from approximately 380 mg of purified fish oil.
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":"20180330","how_supplied":["HOW SUPPLIED Bottles of 30 softgel capsules NDC 13811-544-30. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F [see USP controlled room temperature]."],"id":"68a6bcde-bc1c-e442-e053-2991aa0ac3cd","indications_and_usage":["INDICATIONS Folivane™-PRx DHA NF capsules are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Folivane™-PRx DHA NF 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 13811-544-30 Rx Only Folivane™-PRx DHA NF Rx PRENATAL VITAMIN 30 CAPSULES TRIGEN LABORATORIES Bottle Label"],"precautions":["PRECAUTION Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive."],"set_id":"522c48a7-699d-40d1-9ce6-8a6c514c008b","spl_product_data_elements":["Folivane-PRx DHA ascorbic acid, tribasic calcium phosphate, iron, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium GELATIN GLYCERIN SOYBEAN OIL WATER YELLOW WAX FD&C RED NO. 40 TITANIUM DIOXIDE ETHYL VANILLIN FD&C YELLOW NO. 6 FD&C BLUE NO. 1 ASCORBIC ACID ASCORBIC ACID TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION IRON IRON CHOLECALCIFEROL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID DOCONEXENT DOCONEXENT DOCUSATE SODIUM DOCUSATE maroon Creamy Orange T544 oblong"],"spl_unclassified_section":["CAUTION Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.","Rx Only. Manufactured for: TRIGEN Laboratories, Inc., Sayreville, NJ 08872 www.trigenlab.com Rev. 08/11"],"storage_and_handling":["KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F [see USP controlled room temperature]."],"version":"7","warnings":["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. This product contains soybean oil and fish oil. 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."],"warnings_table":["
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.
"]}