{"active_ingredient":["Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate, USP 10 mg Antitussive Guaifenesin, USP 100 mg Expectorant"],"active_ingredient_table":["
Active ingredients (in each 5 mL = 1 tsp)
Purpose
Codeine phosphate, USP 10 mg
Antitussive
Guaifenesin, USP 100 mg
Expectorant
"],"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":"20241001","id":"f2b561b1-fe8c-440e-a290-ef7522f7da7e","inactive_ingredient":["Inactive ingredients Cherry Flavor, Citric Acid Anhydrous, Glycerin, Masking Agent, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose."],"indications_and_usage":["Uses • temporarily relieves: o cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants o your cough to help you sleep o 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 the 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"],"manufacturer_name":["Proficient Rx LP"],"nui":["N0000193956","N0000008867","N0000009560"],"original_packager_product_ndc":["69367-272"],"package_ndc":["71205-624-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["71205-624"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["995868"],"spl_id":["f2b561b1-fe8c-440e-a290-ef7522f7da7e"],"spl_set_id":["20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d"],"substance_name":["CODEINE PHOSPHATE","GUAIFENESIN"],"unii":["GSL05Y1MN6","495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 71205-624-04 Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive/Expectorant Sugar Free, Alcohol Free, Dye Free Each 5 mL (1 teaspoonful) contains: Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg (WARNING: May be habit-forming) 4 fl. oz. (118 mL) 71205-624-04"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate, USP 10 mg Antitussive Guaifenesin, USP 100 mg Expectorant"],"purpose_table":["
Active ingredients (in each 5 mL = 1 tsp)
Purpose
Codeine phosphate, USP 10 mg
Antitussive
Guaifenesin, USP 100 mg
Expectorant
"],"set_id":"20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d","spl_product_data_elements":["Codeine-Guaifenesin Codeine Phosphate and Guaifenesin Codeine Phosphate Codeine Anhydrous Guaifenesin Guaifenesin CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE"],"spl_unclassified_section":["Drug Facts"],"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). You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088."],"version":"2","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 the 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"]}