{"active_ingredient":["Active ingredient Purpose (in each extended-release bi-layer tablet) Guaifenesin, 600 mg.................................................................Expectorant"],"ask_doctor":["Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)"],"dosage_and_administration":["Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours do not exceed 4 tablets in 24 hours children under 12 years of age: do not use"],"effective_time":"20260513","id":"51b2b733-3d4d-762d-e063-6294a90a41a5","inactive_ingredient":["Inactive ingredients: carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose, sodium starch glycolate."],"indications_and_usage":["Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and helps make cough more productive."],"keep_out_of_reach_of_children":["Keep out of reach of children . In case of accidental overdose, get medical or professional help or contact a Poison Control Center right away (1-800-222-1222)."],"openfda":{"application_number":["M012"],"brand_name":["Giltuss EX Expectorant"],"generic_name":["GILTUSS EX EXPECTORANT"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58552-338-20","58552-338-07"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58552-338"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["636522"],"spl_id":["51b2b733-3d4d-762d-e063-6294a90a41a5"],"spl_set_id":["3b363fb9-c4d3-446f-927c-f705ffc715b5"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"other_safety_information":["Other information Tamper evident: do not use if the carton is open or if printed seal on bottle is broken or missing Store between 20°-25°C (68° -77°F) SAVE CARTON FOR COMPLETE DRUG FACTS"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL GILTUSS EX EXPECTORANT / EXPECTORANTE (Guaifenesin 600 mg) - NDC 58552-338-20 - 20 Tabs Bottle label image description"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":[""],"questions":["Questions or comments? Call 1-787-848-9114 , Monday–Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects. revised: 08/25"],"set_id":"3b363fb9-c4d3-446f-927c-f705ffc715b5","spl_product_data_elements":["Giltuss EX Expectorant Giltuss EX Expectorant CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A GUAIFENESIN GUAIFENESIN G"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if Cough lasts more than than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of serious illness."],"version":"2","warnings":["Warnings Do not use for children under 12 years"]}