{"active_ingredient":["Active ingredient ( in each extended-release tablet) Guaifenesin USP 1200 mg"],"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 accompanied by too much phlegm (mucus)"],"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 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":"20241028","id":"209f74eb-400d-40fe-943e-cecd8aec3a1d","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)"],"indications_and_usage":["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":["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":["ANDA210453"],"brand_name":["Guaifenesin"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58602-811-05","58602-811-73","58602-811-57","58602-811-12","58602-811-60","58602-811-21","58602-811-01","58602-811-02","58602-811-03","58602-811-56","58602-811-64"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58602-811"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310621"],"spl_id":["209f74eb-400d-40fe-943e-cecd8aec3a1d"],"spl_set_id":["c3533119-b307-4bad-8c79-254fea08402b"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (14 Tablet Label) AUROHEALTH NDC 58602-811-05 MAXIMUM STRENGTH Guaifenesin Extended-Release Tablets 1200 mg Guaifenesin 1200 mg - Expectorant RELIEVES CHEST CONGESTION 12 HOUR Relieves Chest Congestion Thins & Loosens Mucus 14 Extended-Release Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Label)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (14 Tablet Carton Label) AUROHEALTH NDC 58602-811-05 Compare to the active Ingredient in Maximum Strength Mucinex ® * MAXIMUM STRENGTH Guaifenesin Extended-Release Tablets 1200 mg Guaifenesin 1200 mg - Expectorant RELIEVES CHEST CONGESTION Relieves Chest Congestion Thins & Loosens Mucus 12 HOUR Actual size 14 Extended-Release Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Carton Label)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets) AUROHEALTH NDC 58602-811-01 Compare to the active Ingredient in Maximum Strength Mucinex ® * MAXIMUM STRENGTH Guaifenesin Extended-Release Tablets 1200 mg Guaifenesin 1200 mg - Expectorant RELIEVES CHEST CONGESTION Relieves Chest Congestion Thins & Loosens Mucus Actual size 14 Extended-Release Tablets 12 HOUR PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Expectorant"],"questions":["Questions? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC. 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India"],"set_id":"c3533119-b307-4bad-8c79-254fea08402b","spl_product_data_elements":["Guaifenesin Guaifenesin GUAIFENESIN GUAIFENESIN SILICON DIOXIDE HYPROMELLOSE 2208 (15000 MPA.S) HYPROMELLOSE 2910 (10000 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 POVIDONE K90 POVIDONE K25 STARCH, CORN white to off-white L;69"],"stop_use":["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":["Other information store between 20° to 25°C (68° to 77°F)"],"version":"8","warnings":["Warnings Do not use for children under 12 years of age"]}