{"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 Taron™-Prex Prenatal with DHA 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 Taron™-Prex Prenatal with DHA capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. Each softgel capsule is oblong, maroon and imprinted with \"T543\" in white ink. 1.2 mg Folic Acid and 265 mg DHA (key omega-3 fatty acid from purified fish oil) Essential vitamins and minerals Gentle stool softener 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 1.2 mg DHA (Docosahexaenoic Acid) 265 mg From approximately 350 mg of Omegas derived from approximately 380 mg of purified fish oil. Docusate Sodium, USP not more than 55 mg Inactive Ingredients: Gelatin, Soybean Oil, Glycerin, Purified Water, Lecithin, Yellow Bees Wax, Natural Orange Flavor, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, FD&C Blue #1."],"description_table":["<table width=\"75%\"> <col width=\"60%\" align=\"left\" valign=\"top\"/> <col width=\"40%\" align=\"right\" valign=\"top\"/> <thead> <tr styleCode=\"Toprule\"> <th colspan=\"2\">Each softgel capsule contains:</th> </tr> </thead> <tbody> <tr styleCode=\"Toprule\"> <td> <content styleCode=\"bold\">Vitamin C</content> (ascorbic acid, USP)</td> <td>25 mg </td> </tr> <tr> <td> <content styleCode=\"bold\">Calcium</content> (tribasic calcium phosphate, NF)</td> <td>160 mg </td> </tr> <tr> <td> <content styleCode=\"bold\">Iron</content> (ferrous fumarate, USP)</td> <td>30 mg </td> </tr> <tr> <td> <content styleCode=\"bold\">Vitamin D<sub>3</sub> </content> (cholecalciferol, USP)</td> <td>170 IU </td> </tr> <tr> <td> <content styleCode=\"bold\">Vitamin E</content> (d-alpha tocopherol, USP)</td> <td>30 IU </td> </tr> <tr> <td> <content styleCode=\"bold\">Vitamin B<sub>6</sub> </content> (pyridoxine hydrochloride, USP)</td> <td>25 mg </td> </tr> <tr> <td> <content styleCode=\"bold\">Folic Acid, USP</content> </td> <td>1.2 mg </td> </tr> <tr> <td> <content styleCode=\"bold\">DHA</content> (Docosahexaenoic Acid)</td> <td>265 mg<footnote>From approximately 350 mg of Omegas derived from approximately 380 mg of purified fish oil.</footnote> </td> </tr> <tr styleCode=\"Botrule\"> <td> <content styleCode=\"bold\">Docusate Sodium, USP</content> </td> <td>not more than 55 mg </td> </tr> </tbody> </table>"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during and/or after pregnancy, one softgel capsule daily or as prescribed by a physician."],"effective_time":"20131212","how_supplied":["HOW SUPPLIED Bottles of 30 softgel capsules NDC 13811-543-30 STORAGE Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°- 86°F) [See USP controlled room temperature]."],"id":"daf154cf-fc0d-4372-b149-eaefd7dd7c83","indications_and_usage":["INDICATIONS Taron™-Prex Prenatal with DHA 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. Taron™-Prex Prenatal with 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 Label NDC 13811-543-30 R x Only Taron ™ -Prex Prenatal with DHA CAP R X PRENATAL VITAMIN 1.2 mg Folic Acid and 265 mg DHA (key omega-3 fatty acid) Essential vitamins and minerals Gentle stool softener 30 CAPSULES TRIGEN LABORATORIES Principal Display Panel - 30 Capsule Label"],"precautions":["PRECAUTION Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias here vitamin B 12 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":"f298af01-aae7-45d8-b2ea-db9139d858fc","spl_product_data_elements":["Taron-Prex Prenatal Ascorbic Acid, Tribasic Calcium Phosphate, Iron, Cholecalciferol, Alpha-Tocopherol, Pyridoxine Hydrochloride, Folic Acid, Doconexent, and Docusate Sodium Ascorbic Acid Ascorbic Acid Tribasic Calcium Phosphate Calcium Cation Ferrous Fumarate Ferrous Cation Cholecalciferol Cholecalciferol Alpha-Tocopherol Alpha-Tocopherol Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid Doconexent Doconexent Docusate Sodium Docusate Gelatin Soybean Oil Glycerin Water Yellow Wax FD&C Red No. 40 Titanium Dioxide Ethyl Vanillin FD&C Yellow No. 6 FD&C Blue No. 1 maroon oblong T543"],"spl_unclassified_section":["R x Only","CAUTION Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.","KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436). 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. 06/11"],"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":"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. 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 SOY AND FISH OIL."]}