{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates – including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride."],"contraindications":["CONTRAINDICATIONS Triveen™-PRx RNF capsules 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 Triveen™-PRx RNF is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. Triveen™-PRx RNF is supplied as an oblong, maroon softgel capsule with \"T558\" imprinted on one side. Each capsule has the following active ingredient: Folic Acid 1.2 mg * from approximately 350 mg of Omega-3s derived from approximately 380 mg of purified fish oil. Each capsule also contains the following ingredients for nutritional supplementation: Vitamin C (ascorbic acid) 28 mg Calcium (tribasic calcium phosphate) 160 mg Iron (ferrous fumarate) 26 mg Vitamin D 3 (cholecalciferol) 400 IU Vitamin E (d-alpha tocopherol) 30 IU Vitamin B 6 (pyridoxine hydrochloride) 25 mg DHA (Docosahexaenoic Acid) 300 mg * Docusate Sodium 55 mg Inactive Ingredients Gelatin, Glycerin, Soybean Oil, Purified water, Lecithin, Yellow Beeswax, Natural Creamy Orange Flavor, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, FD&C Blue #1."],"description_table":["
Each capsule has the following active ingredient:
Folic Acid 1.2 mg
","
*from approximately 350 mg of Omega-3s derived from approximately 380 mg of purified fish oil.
Each capsule also contains the following ingredients for nutritional supplementation:
Vitamin C (ascorbic acid) 28 mg
Calcium (tribasic calcium phosphate) 160 mg
Iron (ferrous fumarate) 26 mg
Vitamin D 3 (cholecalciferol) 400 IU
Vitamin E (d-alpha tocopherol) 30 IU
Vitamin B 6 (pyridoxine hydrochloride) 25 mg
DHA (Docosahexaenoic Acid) 300 mg *
Docusate Sodium 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":"20170811","general_precautions":["General Folic acid, when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B 12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B 12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12 deficiency. Folate therapy alone is inadequate for the treatment of B 12 deficiency."],"how_supplied":["HOW SUPPLIED Bottles of 30 softgel capsules. NDC 13811-558-30 Bottles of 60 softgel capsules. NDC 13811-558-60"],"id":"56816d1d-45d9-72db-e054-00144ff88e88","indications_and_usage":["INDICATIONS AND USAGE Triveen™-PRx RNF is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 13811- 558 -30 Rx Only Triveen™-PRx RNF Capsules 30 CAPSULES TRIGEN LABORATORIES Triveen-PRx"],"precautions":["PRECAUTIONS General Folic acid, when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B 12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B 12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12 deficiency. Folate therapy alone is inadequate for the treatment of B 12 deficiency."],"set_id":"efd50a93-2e7c-49eb-ae7e-b7764576f5a9","spl_product_data_elements":["Triveen-PRx RNF folic acid, ascorbic acid, tribasic calcium phosphate, iron, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, 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 FOLIC ACID FOLIC ACID TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION IRON IRON CHOLECALCIFEROL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL PYRIDOXINE HYDROCHLORIDE PYRIDOXINE DOCONEXENT DOCONEXENT DOCUSATE SODIUM DOCUSATE (maroon) (Creamy Orange) T558 oblong"],"spl_unclassified_section":["CAUTION Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.","PATIENT INFORMATION Triveen™-PRx RNF is a prescription vitamin for use only under the direction and supervision of a licensed physician.","INTERACTIONS Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Drugs which may interact with folate include: Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of this AED in the blood and allowing breakthrough seizures to occur. Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine. Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. Colestipol: Reduces folic acid absorption and reduces serum folate levels. Cycloserine: Reduces folic acid absorption and reduces serum folate levels. Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. Smoking and Alcohol: Reduced serum folate levels have been noted. Sulfasalazine: Inhibits the absorption and metabolism of folic acid. Metformin treatment in patients with type 2 diabetes decreases serum folate. Warfarin can produce significant impairment in folate status after a 6-month therapy.","Call your doctor about side effects. You may report by calling 888 9 TRIGEN (888-987-4436). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rx Only 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. Manufactured for: TRIGEN Laboratories, Inc. Sayreville, NJ 08872 www.trigenlab.com Rev. 08/11"],"storage_and_handling":["STORAGE 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":["WARNINGS Daily ingestion of more than 3 g per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids – including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. This product contains soybean oil and fish oil."]}