{"active_ingredient":["Active ingredient (in each extended-release bi-layer 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":"20171218","id":"cc734890-e42c-454a-b771-3ecd169d161a","inactive_ingredient":["Inactive ingredients carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF"],"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."],"openfda":{"application_number":["NDA021282"],"brand_name":["Mucinex"],"generic_name":["GUAIFENESIN"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"original_packager_product_ndc":["63824-008"],"package_ndc":["67544-149-53","67544-149-70","67544-149-80"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["67544-149"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["636522","891301"],"spl_id":["cc734890-e42c-454a-b771-3ecd169d161a"],"spl_set_id":["1c84bf00-ebaa-4e69-a2c6-716631d209d9"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 600mg NDC 67544-149 Guaifenesin (Mucinex) ER 600mg - Rx Only Bottle Label 600mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Expectorant"],"questions":["Questions? 1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number."],"set_id":"1c84bf00-ebaa-4e69-a2c6-716631d209d9","spl_product_data_elements":["Mucinex Guaifenesin Guaifenesin Guaifenesin CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) FD&C BLUE NO. 1 ALUMINUM OXIDE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO blue and white Mucinex;600"],"spl_unclassified_section":["Drug Facts","Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in England","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 60 67544-149-53 120 67544-149-70 180 67544-149-80 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 20171218DKJ Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["
Count 600 mg
60 67544-149-53
120 67544-149-70
180 67544-149-80
"],"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":"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."]}