{"adverse_reactions":["ADVERSE REACTIONS Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION TriAdvance is a prescription prenatal multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. It is a yellow-speckled tablet debossed \"TL020\". Each tablet for oral administration contains: Vitamin A (beta-carotene) 2700 I.U. Vitamin C (ascorbic acid) 120 mg Vitamin D 3 (cholecalciferol) 400 I.U. Vitamin E (dl-alpha-tocopheryl acetate) 30 I.U. Vitamin B 1 (thiamine mononitrate) 3 mg Vitamin B 2 (riboflavin) 3.4 mg Niacin (niacinamide) 20 mg Vitamin B 6 (pyridoxine hydrochloride) 20 mg Folic Acid 1 mg Vitamin B 12 (cyanocobalamin) 12 mcg Calcium (calcium carbonate) 200 mg Iron (carbonyl iron) 90 mg Magnesium (magnesium oxide) 30 mg Zinc (zinc oxide) 25 mg Copper (cupric oxide) 2 mg Docusate Sodium 50 mg Inactive Ingredients: Microcrystalline Cellulose, TriPotassium Citrate, Gum Arabic, Fumed Silica, Croscarmellose Sodium, Citric Acid, Povidone K30, Sodium Carboxymethyl Cellulose, Magnesium Stearate, Stearic Acid, Dextrin, Dextrose, Lecithin, Sodium Citrate."],"description_table":["<table> <col/> <col/> <tbody> <tr> <td> <content styleCode=\"bold\">Vitamin A</content> (beta-carotene) </td> <td>2700 I.U.</td> </tr> <tr> <td> <content styleCode=\"bold\">Vitamin C</content> (ascorbic acid) </td> <td>120 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Vitamin D <sub>3</sub> </content> (cholecalciferol) </td> <td>400 I.U.</td> </tr> <tr> <td> <content styleCode=\"bold\">Vitamin E</content> (dl-alpha-tocopheryl acetate) </td> <td>30 I.U.</td> </tr> <tr> <td> <content styleCode=\"bold\">Vitamin B <sub>1</sub> </content> (thiamine mononitrate) </td> <td>3 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Vitamin B <sub>2</sub> </content> (riboflavin) </td> <td>3.4 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Niacin</content> (niacinamide) </td> <td>20 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Vitamin B <sub>6</sub> </content> (pyridoxine hydrochloride) </td> <td>20 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Folic Acid</content> </td> <td>1 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Vitamin B <sub>12</sub> </content> (cyanocobalamin) </td> <td>12 mcg</td> </tr> <tr> <td> <content styleCode=\"bold\">Calcium</content> (calcium carbonate) </td> <td>200 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Iron</content> (carbonyl iron) </td> <td>90 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Magnesium</content> (magnesium oxide) </td> <td>30 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Zinc</content> (zinc oxide) </td> <td>25 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Copper</content> (cupric oxide) </td> <td>2 mg</td> </tr> <tr> <td> <content styleCode=\"bold\">Docusate Sodium</content> </td> <td>50 mg</td> </tr> </tbody> </table>"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual dosage is one tablet daily, or as prescribed by a physician."],"effective_time":"20170811","general_precautions":["General The calcium content should be considered before prescribing for patients with kidney stones. Do not exceed the recommended dosage."],"how_supplied":["HOW SUPPLIED TriAdvance is supplied in bottles of 90 tablets. NDC 13811-529-90"],"id":"567fc4b2-15fa-429e-e054-00144ff88e88","indications_and_usage":["INDICATIONS AND USAGE TriAdvance is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. TriAdvance can also be beneficial in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 13811-529-90 Rx Only TriAdvance Prenatal Vitamin Tablets 90 TABLETS TRIGEN LABORATORIES TriAdvance"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS General The calcium content should be considered before prescribing for patients with kidney stones. Do not exceed the recommended dosage. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functions, and of concomitant disease or other drug therapy."],"set_id":"1dca1f73-f6cf-4356-b831-3458d953d959","spl_product_data_elements":["TriAdvance beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, and docusate sodium IRON IRON MAGNESIUM OXIDE MAGNESIUM CATION ZINC OXIDE ZINC OXIDE CUPRIC OXIDE CUPRIC CATION DOCUSATE SODIUM DOCUSATE MICROCRYSTALLINE CELLULOSE POTASSIUM CITRATE ACACIA SILICON DIOXIDE CROSCARMELLOSE SODIUM CITRIC ACID MONOHYDRATE POVIDONE K30 CARBOXYMETHYLCELLULOSE MAGNESIUM STEARATE STEARIC ACID ICODEXTRIN DEXTROSE SODIUM CITRATE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM CATION speckled TL020 caplet"],"spl_unclassified_section":["Call your doctor about side effects. You may report side effects 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. 05/11"],"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]. Note that contact with moisture may produce surface discoloration or erosion of the tablet."],"version":"5","warnings":["WARNINGS 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. 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."]}