{"active_ingredient":["Drug Facts Active ingredient (in each extended-release tablet) Guaifenesin 600 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)"],"do_not_use":["Do not use ■ for children under 12 years of age"],"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 the timing of meals ■ adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. ■ children under 12 years of age: do not use"],"effective_time":"20260408","id":"4ef7dae3-9082-bc3b-e063-6294a90a9a75","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":["Dr. Simi Mucus Relief"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Farmacias De Similares TX LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["85786-302-40"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["85786-302"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["636522"],"spl_id":["4ef7dae3-9082-bc3b-e063-6294a90a9a75"],"spl_set_id":["4ef7dae3-9081-bc3b-e063-6294a90a9a75"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"other_safety_information":["Other information ■ store between 20-25°C (68-77°F) ■ retain carton for complete product information and warnings"],"package_label_principal_display_panel":["Carton labeling Carton labeling"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Expectorant"],"questions":["Questions or comments? 855-280-1079"],"set_id":"4ef7dae3-9081-bc3b-e063-6294a90a9a75","spl_product_data_elements":["Dr. Simi Mucus Relief Guaifenesin SODIUM STARCH GLYCOLATE TYPE A MICROCRYSTALLINE CELLULOSE HYPROMELLOSE 2910 (15 MPA.S) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) MAGNESIUM STEARATE GUAIFENESIN GUAIFENESIN G;600"],"spl_unclassified_section":["Principal Display Panel NDC: 85786-302-40 DR. SIMI Mucus Relief Guaifenesin Extended-Release Tablets, 600 mg Expectorant 12 hour • Relieves Chest congestion • Thins & Loosens mucus • Immediate and Extended Release 40 EXTENDED-RELEASE TABLETS †Compare to the active ingredient in Mucinex® †This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® DO NOT USE IF BLISTER UNITS ARE TORN OR BROKEN Made in India Distributed by: FARMACIAS DE SIMILARES TX LLC 800 Brazos St Ste 260, Austin, TX, 78701, USA customerservice@drsimi.com www.drsimi.com"],"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."],"version":"1","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 a serious illness. If pregnant or breast-feeding, ask a health professional before use. 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)."]}