{"active_ingredient":["Active ingredient (in each extended-release bi-layer tablet) Guaifenesin 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 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: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours ■ children under 12 years of age: do not use"],"effective_time":"20251219","id":"46510bfe-1c72-5f4d-e063-6294a90aa930","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 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":["ANDA213420"],"brand_name":["Guaifenesin"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Safeway, Inc"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["21130-554-27"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["21130-554"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310621"],"spl_id":["46510bfe-1c72-5f4d-e063-6294a90aa930"],"spl_set_id":["f32e5b0f-1fd9-9b33-e053-2995a90a8103"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["PDP Guaifenesin ER tab 1200mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use"],"purpose":["Purpose Expectorant"],"questions":["Questions? contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST"],"set_id":"f32e5b0f-1fd9-9b33-e053-2995a90a8103","spl_product_data_elements":["Guaifenesin Guaifenesin CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) SODIUM STARCH GLYCOLATE TYPE A MAGNESIUM STEARATE HYPROMELLOSE 2910 (5 MPA.S) MICROCRYSTALLINE CELLULOSE GUAIFENESIN GUAIFENESIN G;1200"],"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 ■ Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing. ■ store between 20-25°C (68-77°F)"],"version":"6","warnings":["Do not use ■ for children under 12 years of age"]}