{"active_ingredient":["ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE BI-LAYER TABLET) GUAIFENESIN 1200MG"],"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 TIMING OF MEALS ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: TAKE 1 TABLET EVERY 12 HOURS. DO NOT EXCEED 2 TABLETS IN 24 HOURS. CHILDREN UNDER 12 YEARS OF AGE: DO NOT USE."],"effective_time":"20230304","id":"f61d3ae0-11ec-2a82-e053-2995a90a95da","inactive_ingredient":["INACTIVE INGREDIENTS CARBOMER HOMOPOLYMER TYBE 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 PASSAGEWAY 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 (1-800-222-1222) IMMEDIATELY."],"openfda":{"application_number":["ANDA213420"],"brand_name":["GUAIFENESIN - ODAAT 1200 MG"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["LODAAT LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["83139-175-01"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["83139-175"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310621"],"spl_id":["f61d3ae0-11ec-2a82-e053-2995a90a95da"],"spl_set_id":["f61d3ae0-11eb-2a82-e053-2995a90a95da"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"],"upc":["0798190237428"]},"package_label_principal_display_panel":["PDP DF BOX"],"purpose":["PURPOSE EXPECTORANT"],"questions":["QUESTIONS? CALL TOLL-FREE +1 630 852 7544"],"set_id":"f61d3ae0-11eb-2a82-e053-2995a90a95da","spl_product_data_elements":["GUAIFENESIN - ODAAT 1200 MG GUAIFENESIN GUAIFENESIN GUAIFENESIN CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A HYPROMELLOSE, UNSPECIFIED G;1200"],"storage_and_handling":["OTHER INFORMATION STORE BETWEEN 20-25°C (68-77°F)"],"version":"1","warnings":["WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE ASK DOCTOR BEFORE USE IF YOU HAVE: PERSISTENT OR CHRONIC COUGH SUCH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS) COUGH ACCOMPANIED BY EXCESSIVE PHLEGM STOP USE AND ASK A DOCTOR IS COUGH LASTS FOR MORE THAN 7 DAYS, RECURS, OR IS ACCOMPANIED BY FEVER, RASH, OR PERSISTENT HEADACHE. THESE COULD BE SIGNS OF A SERIOUS CONDITION. IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE."]}