{"active_ingredient":["Active ingredient Guaifenesin 600 mg (for 600 mg) Guaifenesin 1200 mg (for 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)"],"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 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. (For 600mg) adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg) children under 12 years of age: do not use"],"effective_time":"20230408","id":"77d8fc95-d94b-42f5-97ae-b5ff59ef638b","inactive_ingredient":["Inactive ingredients carbomer homopolymer type B; hypromellose, Lake of FD&C Blue 1, 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":["Crcle Guaifenesin Extended-Release Tablets, 600 mg","Crcle Guaifensin Extended Release Tablet, 1200 mg"],"generic_name":["GUAIFENESIN EXTENDED-RELEASE","GUAIFENSIN EXTENDED-RELEASE"],"is_original_packager":[true],"manufacturer_name":["Innovus Pharmaceuticals, Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["57483-270-01","57483-280-02"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["57483-270","57483-280"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310621","636522"],"spl_id":["77d8fc95-d94b-42f5-97ae-b5ff59ef638b"],"spl_set_id":["bba4b91a-bea9-41be-9588-5fb1483c7d10"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"other_safety_information":["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)"],"package_label_principal_display_panel":["C'rcle Guaifenesin Extended-Release Tablets 600 mg / Expectorant 100 (20x5) Extended-Release Bi-Layer Tablets C'rcle Guaifenesin Extended-Release Tablets 1200 mg / Expectorant 56 (14x4) Extended-Release Bi-Layer Tablets image description image description"],"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":"bba4b91a-bea9-41be-9588-5fb1483c7d10","spl_product_data_elements":["Crcle Guaifenesin Extended-Release Tablets, 600 mg Guaifenesin Extended-Release GUAIFENESIN GUAIFENESIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE FD&C BLUE NO. 1 HYPROMELLOSES MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO white and blue G;600 Crcle Guaifensin Extended Release Tablet, 1200 mg Guaifensin Extended-Release GUAIFENESIN GUAIFENESIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE FD&C BLUE NO. 1 HYPROMELLOSES MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO white-blue ellipitcal 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."],"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)"]}