{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"contraindications":["CONTRAINDICATIONS VemaVite™-PRx 2 is 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 VemaVite™-PRx 2 is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish-based DHA. Each softgel capsule is an oblong, maroon capsule imprinted with \"T598\". Each softgel capsule contains: * Derived from at least 338.1 mg omega-3s from at least 476.1 mg purified fish oil. Vitamin C (ascorbic acid, USP) 28 mg Calcium (tribasic calcium phosphate, NF) 160 mg Iron (ferrous fumarate, USP) 27 mg Vitamin D3 (cholecalciferol, USP) 400 IU Vitamin E (d-alpha tocopherol, USP) 30 IU Vitamin B6 (pyridoxine hydrochloride, USP) 25 mg Folic Acid, USP 1.25 mg DHA (docosahexaenoic acid, contained in the oil derived from fish) 300 mg * Docusate Sodium, USP 55 mg Other Ingredients: bovine gelatin, glycerin, sorbitol, purified water, FD&C Red #40, titanium dioxide, ethyl vanillin, FD&C Blue #1, FD&C Yellow #5, soybean oil, soy lecithin, yellow beeswax, natural and artificial orange cream flavor."],"description_table":["
Each softgel capsule contains:
*Derived from at least 338.1 mg omega-3s from at least 476.1 mg purified fish oil.
Vitamin C (ascorbic acid, USP) 28 mg
Calcium (tribasic calcium phosphate, NF) 160 mg
Iron (ferrous fumarate, USP) 27 mg
Vitamin D3 (cholecalciferol, USP) 400 IU
Vitamin E (d-alpha tocopherol, USP) 30 IU
Vitamin B6 (pyridoxine hydrochloride, USP) 25 mg
Folic Acid, USP 1.25 mg
DHA (docosahexaenoic acid, contained in the oil derived from fish) 300 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":"20180322","how_supplied":["HOW SUPPLIED Bottles of 30 softgel capsules. NDC 13811-598-30 KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store at Controlled Room Temperature 20°-25°C (68°-77°F). [See USP]."],"id":"680767f7-2ed9-280c-e053-2991aa0a2621","indications_and_usage":["INDICATIONS VemaVite™-PRx 2 softgel 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. VemaVite™-PRx 2 may be useful in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 13811-598-30 Rx Only VemaVite™-PRx 2 Softgel Capsule 30 CAPSULES TRIGEN LABORATORIES 1 2 3"],"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.","CAUTION Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day."],"set_id":"e36a021b-3035-474b-8610-4e58647d3183","spl_product_data_elements":["VemaVite-PRx 2 with Fish-Based DHA Ascorbic Acid, Tribasic Calcium Phosphate, Ferrous Fumarate, Cholecalciferol, Alpha-Tocopherol, Pyridoxine Hydrochloride, Folic Acid, Doconexent, and Docusate Sodium FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 5 GELATIN GLYCERIN WATER SOYBEAN OIL TITANIUM DIOXIDE ETHYL VANILLIN YELLOW WAX SORBITOL LECITHIN, SOYBEAN ASCORBIC ACID ASCORBIC ACID TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION CHOLECALCIFEROL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID DOCONEXENT DOCONEXENT FERROUS FUMARATE FERROUS CATION DOCUSATE SODIUM DOCUSATE maroon Creamy Orange T598 oblong"],"spl_unclassified_section":["Rx Only 1.25 mg Folic Acid and 300 mg DHA (key omega-3 fatty acid) Essential vitamins and minerals Gentle stool softener","Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436). All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence. Rx Only Manufactured for: TRIGEN Laboratories, Inc., Bridgewater, NJ 08807 www.trigenlab.com Rev. 07/2017 logo"],"version":"7","warnings":["WARNINGS A ccidental 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 FISH OIL AND SOY. 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."]}