{"active_ingredient":["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":"20210503","id":"349de2f9-ec60-43d7-990a-074c673aa7e3","inactive_ingredient":["INACTIVE INGREDIENTS carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone"],"indications_and_usage":["USE(S) 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":["ANDA209215"],"brand_name":["Mucus Relief"],"generic_name":["GUAIFENESIN"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"original_packager_product_ndc":["0904-6986"],"package_ndc":["71610-499-12","71610-499-53"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["71610-499"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["636522"],"spl_id":["349de2f9-ec60-43d7-990a-074c673aa7e3"],"spl_set_id":["01af03f1-5d1b-4893-b7db-7092ba66e842"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 600 mg NDC 71610-499 - Guaifenesin ER 600 mg Tablets Bottle Label 600 mg"],"pregnancy_or_breast_feeding":["IF PREGNANT OR BREAST-FEEDING, ask a health professional before use."],"purpose":["PURPOSE Expectorant"],"set_id":"01af03f1-5d1b-4893-b7db-7092ba66e842","spl_product_data_elements":["Mucus Relief Guaifenesin GUAIFENESIN GUAIFENESIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE HYPROMELLOSE, UNSPECIFIED CELLULOSE, MICROCRYSTALLINE POVIDONE, UNSPECIFIED G233"],"spl_unclassified_section":["QUESTIONS? 1-800-616-2471 You may also report side effects to this phone number.","Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 600 mg 12 71610-499-12 60 71610-499-53 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20201217JH Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["
Count600 mg
1271610-499-12
6071610-499-53
"],"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 seal on the bottle printed \"SEALED for YOU PROTECTION\" is broken or missing. store between 20 to 25°C (68 to 77°F)"],"version":"2","warnings":["WARNING ."]}