{"boxed_warning":["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."],"effective_time":"20130925","id":"3e418742-9651-4def-8a2c-d25179ccf59c","openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL a48d1ddc-figure-02"],"set_id":"4d130290-831f-4eb0-86a7-68fefc5cd430","spl_product_data_elements":["FE C Tab Plus Vitamin C Ascorbic Acid, Carbonyl Iron, Folic Acid, Vitamin B-12 Cyanocobalamin ASCORBIC ACID ASCORBIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN IRON PENTACARBONYL FERROUS CATION CROSCARMELLOSE SODIUM ETHYLCELLULOSES FD&C RED NO. 40 FD&C YELLOW NO. 6 CELLULOSE, MICROCRYSTALLINE ANHYDROUS CITRIC ACID CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS HYPROMELLOSES MALTODEXTRIN MAGNESIUM STEARATE MINERAL OIL POLYETHYLENE GLYCOLS STEARIC ACID TITANIUM DIOXIDE POVIDONE K29/32 Maroon BP802"],"spl_unclassified_section":["FE C Tab Plus Rx Only","Each Tablet Contains: Vitamin C (Ascorbic Acid) …………………. 250mg Carbonyl Iron ……………………………………….100mg Folic Acid ………………………………………………..1mg Vitamin B-12 (Cyanocobalamin) ………… 25mcg","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.","Inactive Ingredients Include: Citric Acid Anhydrous, Croscarmellose Sodium, Dicalcium Phosphate, Ethyl Cellulose, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Hypromellose, Maltodextrin, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Stearic Acid, Titanium Dioxide. Store at Controlled Room Temperature 20º-25ºC [68º-77ºF]; [See USP Controlled Room Temperature] Manufactured for: Boca Pharmacal, LLC Coral Springs, FL 33065 1-800-354-8460 www.bocapharmacal.com Rev. 08/13 a48d1ddc-figure-01"],"version":"3"}