{"active_ingredient":["Active ingredient (in each extended-release tablet) Guaifenesin, USP"],"dosage_and_administration":["Directions do not crush, chew or break extended-release tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children over 12 years of age and over: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours. children under 12 years of age: do not use. Other information store between 20-25°C (68-77°F) TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING."],"effective_time":"20260212","id":"4aa4fb35-6f33-6e33-e063-6394a90a495e","inactive_ingredient":["Inactive Ingredients colloidal silicon dioxide, FD&C blue # 2, aluminum lake, hypromellose, magnesium stearate, povidone. Questions call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984."],"indications_and_usage":["Uses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial mucus and make coughs more productive"],"keep_out_of_reach_of_children":["Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"openfda":{"application_number":["ANDA209254"],"brand_name":["Guaifenesin"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Ohm Laboratories, Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["51660-566-41","51660-566-21","51660-566-68","51660-567-54","51660-567-86","51660-567-58"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["51660-566","51660-567"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310621","636522"],"spl_id":["4aa4fb35-6f33-6e33-e063-6394a90a495e"],"spl_set_id":["7076e42a-17ff-4c42-9963-2dc02c0a5e49"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel - Guaifenesin ER Tablets, 600 mg spl-guaifenesin-ohm","Principal Display Panel - Guaifenesin ER Tablets, 1200 mg spl-guaifenesin-ohm2"],"purpose":["Purpose Expectorant"],"questions":["Questions call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984."],"recent_major_changes":[""],"set_id":"7076e42a-17ff-4c42-9963-2dc02c0a5e49","spl_product_data_elements":["Guaifenesin Guaifenesin SILICON DIOXIDE FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE, UNSPECIFIED GUAIFENESIN GUAIFENESIN blue/white mottled RH;98 Guaifenesin Guaifenesin SILICON DIOXIDE FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE, UNSPECIFIED GUAIFENESIN GUAIFENESIN blue/white mottled RH;99"],"spl_unclassified_section":["Keep the carton. It contains important information. See end panel for expiration date. †OHM and OHM Logo are trademarks of Ohm Laboratories, Inc. All other trademarks are the property of their respective owners. Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 PRODUCT OF INDIA R0425 CODE No.: PB/DRUGS/1809-0SP"],"version":"4","warnings":["Warnings Do not use for children under 12 years of age Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back or occurs with fever, rash, or persistent headache. These could be signs of serious illness. If pregnant or breast-feeding, ask a health professional before use."]}