{"effective_time":"20130924","id":"a1b0a7f4-c9f0-443c-9cc9-c44f3a2cfd4a","openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL f14a4a6a-figure-02"],"set_id":"c81325e0-c2db-4412-89a9-236a6733f229","spl_product_data_elements":["FE C Tab Iron, Vitamin C ASCORBIC ACID ASCORBIC ACID IRON PENTACARBONYL FERROUS CATION SILICON DIOXIDE STEARIC ACID FERROSOFERRIC OXIDE TITANIUM DIOXIDE HYPROMELLOSES FD&C BLUE NO. 2 CELLULOSE, MICROCRYSTALLINE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM STEARATE POLYETHYLENE GLYCOLS FD&C RED NO. 40 FERRIC OXIDE RED FERRIC OXIDE YELLOW PROPYLENE GLYCOL TRIACETIN"],"spl_unclassified_section":["FE C Tab","Inactive ingredients: Black iron oxide, dicalcium phosphate, FD&C Blue #2, FD&C Red #40, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, red iron oxide, silicon dioxide, stearic acid, titanium dioxide, triacetin, yellow iron oxide. STORE AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F) f14a4a6a-figure-01","DIRECTIONS: Adults and Children 12 years and over – One tablet daily or as directed by a physician. Children under 12 years: Consult a physician.","WARNINGS: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron products may occasionally cause constipation or diarrhea. If you are pregnant or nursing a baby, seek the advice of a health professional before using this product. 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.","DO NOT ACCEPT IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING. Manufactured for: Boca Pharmacal, LLC Coral Springs, FL 33065 www.bocapharmacal.com 1-800-354-8460 Rev. 08/13 077T"],"spl_unclassified_section_table":["<table> <col/> <tbody> <tr> <td valign=\"top\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"> <content styleCode=\"bold\">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.</content> </td> </tr> </tbody> </table>"],"version":"4"}