{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION For 600 mg: Active ingredient (in each extended-release tablet) Guaifenesin, USP 600 mg For 1200 mg: Active ingredient (in each extended-release tablet) Guaifenesin, USP 1200 mg"],"ask_doctor":["OTC - ASK DOCTOR SECTION 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)"],"do_not_use":["OTC - DO NOT USE SECTION Do not use • for children under 12 years of age"],"dosage_and_administration":["DOSAGE & ADMINISTRATION SECTION Directions For 600 mg • 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 12 years of age and over: 1 or 2 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 For 1200 mg • 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 12 years of age and over: 1 extended - release tablet every 12 hours. Do not exceed 2 extended - release tablets in 24 hours. • children under 12 years of age: do not use"],"effective_time":"20240207","id":"10c427f2-f75b-9e93-e063-6294a90ab0ef","inactive_ingredient":["INACTIVE INGREDIENT SECTION Inactive ingredients colloidal silicon dioxide, copovidone, FD&C blue No. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid"],"indications_and_usage":["INDICATIONS & USAGE SECTION Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive"],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA217780"],"brand_name":["Guaifenesin Extended Release 600 mg","Guaifenesin Extended Release 1200 mg"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["TIME CAP LABORATORIES, INC."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["49483-723-50","49483-724-70"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["49483-723","49483-724"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310621","636522"],"spl_id":["10c427f2-f75b-9e93-e063-6294a90ab0ef"],"spl_set_id":["10c42869-7df0-3046-e063-6394a90aa679"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"],"upc":["0349483724707","0349483723502"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL guaifenesin-1200mg-70ct-label guaifenesin-600mg-500ct-label"],"pregnancy_or_breast_feeding":["OTC - PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding, ask a health professional before use."],"purpose":["OTC - PURPOSE SECTION Purpose Expectorant"],"questions":["OTC - QUESTIONS SECTION Questions or comments? Call 1-877-290-4008"],"set_id":"10c42869-7df0-3046-e063-6394a90aa679","spl_product_data_elements":["Guaifenesin Extended Release 600 mg Guaifenesin SILICON DIOXIDE COPOVIDONE K25-31 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE 102 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID FD&C BLUE NO. 1 ALUMINUM LAKE GUAIFENESIN GUAIFENESIN Blue and White 42 Guaifenesin Extended Release 1200 mg Guaifenesin SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE 102 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID FD&C BLUE NO. 1 ALUMINUM LAKE COPOVIDONE K25-31 GUAIFENESIN GUAIFENESIN Blue and White 41"],"stop_use":["OTC - STOP USE SECTION 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 a serious illness."],"storage_and_handling":["STORAGE AND HANDLING SECTION Other information • store at 20-25°C (68-77°F)"],"version":"1","warnings":["WARNINGS SECTION"]}