{"active_ingredient":["Active ingredient(s) Active ingredient (in each extended-release tablet) Guaifenesin 600 mg Active ingredient (in each extended-release 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)"],"do_not_use":["Do not use for children under 12 years of age"],"dosage_and_administration":["Directions 600 mg do not crush, chew, or break extended-release 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 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours. children under 12 years of age: do not use 1200 mg do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours. children under 12 years of age: do not use"],"effective_time":"20241007","id":"f1b3934b-1fc2-4ce8-9465-e1f031daf9c5","inactive_ingredient":["Inactive ingredients carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc"],"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":["ANDA207342"],"brand_name":["Guaifenesin"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Amneal Pharmaceuticals LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["65162-036-02","65162-036-03","65162-036-06","65162-037-28","65162-037-03","65162-037-06"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["65162-036","65162-037"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310621","636522"],"spl_id":["f1b3934b-1fc2-4ce8-9465-e1f031daf9c5"],"spl_set_id":["ad67e6fd-a68f-44db-9718-84a2cef86e09"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 600 mg Blister 600 mg Blister Carton 600 mg Label 600 mg Carton 1200 mg Blister 1200 mg Blister Carton 1200 mg Label 1200 mg Carton"],"pregnancy_or_breast_feeding":["Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Expectorant"],"questions":["Questions 1-877-835-5472 You may also report side effects to this phone number. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2024-01"],"set_id":"ad67e6fd-a68f-44db-9718-84a2cef86e09","spl_product_data_elements":["Guaifenesin Guaifenesin GUAIFENESIN GUAIFENESIN CARBOMER COPOLYMER TYPE A SILICON DIOXIDE FD&C BLUE NO. 1 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE TALC light blue AN036 Guaifenesin Guaifenesin GUAIFENESIN GUAIFENESIN CARBOMER COPOLYMER TYPE A SILICON DIOXIDE FD&C BLUE NO. 1 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE TALC light blue AN037"],"spl_unclassified_section":["Other information Tamper evident: Do not use if printed foil under cap is broken or missing."],"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":["Storage store between 20° to 25°C (68° to 77°F)"],"version":"12","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. Pregnancy/Breastfeeding 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)."]}