{"active_ingredient":["Active ingredient (in each teaspoonful (5 mL)) Codeine Phosphate USP 10 mg","Active ingredient (in each teaspoonful (5 mL)) Guaifenesin USP 100 mg"],"ask_doctor":["Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs"],"dosage_and_administration":["Directions do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor."],"dosage_and_administration_table":["
Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor.
Children under 6 years of age: Consult a doctor.
"],"effective_time":"20260401","id":"4e6980b2-573c-2636-e063-6294a90ac0f4","inactive_ingredient":["Inactive ingredients Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol."],"indications_and_usage":["Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough 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":["M012"],"brand_name":["Codeine-Guaifenesin"],"generic_name":["CODEINE PHOSPHATE AND GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Method Pharmaceuticals, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58657-500-04","58657-500-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58657-500"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["995868"],"spl_id":["4e6980b2-573c-2636-e063-6294a90ac0f4"],"spl_set_id":["fe126254-6ee6-48c3-965c-96e4276a5314"],"substance_name":["CODEINE PHOSPHATE","GUAIFENESIN"],"unii":["GSL05Y1MN6","495W7451VQ"]},"package_label_principal_display_panel":["Principal Display Panel NDC 58657-500-16 Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant 16 fl. oz. (473 mL) label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purpose Antitussive","Purpose Expectorant"],"set_id":"fe126254-6ee6-48c3-965c-96e4276a5314","spl_product_data_elements":["Codeine-Guaifenesin Codeine Phosphate and Guaifenesin CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL WATER SODIUM CITRATE SUCRALOSE SORBITOL SODIUM BENZOATE CODEINE PHOSPHATE CODEINE ANHYDROUS GUAIFENESIN GUAIFENESIN"],"stop_use":["Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition."],"storage_and_handling":["Other information Store at controlled room temperature 15°-30°C (59°-86°F)."],"version":"16","warnings":["Warnings Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs When using this product giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. may cause or aggravate constipation Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition. 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."],"when_using":["When using this product giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. may cause or aggravate constipation"]}