{"active_ingredient":["DRUG FACTS Active Ingredient (in each 5 mL cup) Purpose Guaifenesin, USP 100mg .............................................................................................................................. Expectorant Dextromethorphan HBr, USP 10mg ...................................................................................................... Cough Suppressant Active Ingredient (in each 10 mL cup) Purpose Guaifenesin, USP 200mg .............................................................................................................................. Expectorant Dextromethorphan HBr, USP 20mg .......................................................................................................Cough Suppressant Inactive Ingredients Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate."],"ask_doctor":["Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking any other drug"],"do_not_use":["Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug."],"dosage_and_administration":["DIRECTIONS: Age Dose Adults and children 12 years and over 10 mL every 4 hours Max dose is 60mL in 24-hours Children under 12 years of age Ask a doctor"],"dosage_and_administration_table":["
AgeDose
Adults and children 12 years and over10 mL every 4 hoursMax dose is 60mL in 24-hours
Children under 12 years of ageAsk a doctor
"],"effective_time":"20231101","how_supplied":["HOW SUPPLIED: Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms: NDC 69339-149-05 (1) unit dose cup 5mL NDC 69339-149-19 100 (10x10) unit dose cups 5mL Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms: NDC 69339-150-01 (1) unit dose cup 10mL NDC 69339-150-19 100 (10x10) unit dose cups 10mL"],"id":"6bc4ec89-dcf0-4e03-ac41-abb85c1a5efd","inactive_ingredient":["Inactive Ingredients Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate."],"indications_and_usage":["Uses • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold."],"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":["M012"],"brand_name":["Guaifenesin Syrup and Dextromethorphan"],"generic_name":["GUAIFENESIN SYRUP AND DEXTROMETHORPHAN"],"is_original_packager":[true],"manufacturer_name":["Natco Pharma USA LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["69339-149-05","69339-149-19","69339-150-01","69339-150-19"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["69339-149","69339-150"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["6bc4ec89-dcf0-4e03-ac41-abb85c1a5efd"],"spl_set_id":["ad9026f4-f0b6-4d02-aa44-f0460eeefc0e"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 69339-149-05 GUAIFENESIN SYRUP & DEXTROMETHORPHAN HBr 100 mg/10 mg per 5 mL For Institutional Use Only 3 69339 14905 8 Lot # 111 Exp: 09/22/2020 See Insert Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE 5mL Cup Label","PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 69339-150-01 GUAIFENESIN SYRUP & DEXTROMETHORPHAN HBr 200 mg/20 mg per 10 mL For Institutional Use Only 3 69339 15001 6 Lot # 111 Exp: 09/22/2020 See Insert Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE 10 mL cup label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use"],"purpose":["Non-Narcotic - Alcohol Free"],"set_id":"ad9026f4-f0b6-4d02-aa44-f0460eeefc0e","spl_product_data_elements":["Guaifenesin Syrup and Dextromethorphan Guaifenesin Syrup and Dextromethorphan ANHYDROUS CITRIC ACID DEXTROSE FD&C RED NO. 40 MENTHOL GLYCERIN HIGH FRUCTOSE CORN SYRUP WATER SACCHARIN SODIUM SODIUM BENZOATE GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Guaifenesin Syrup and Dextromethorphan Guaifenesin Syrup and Dextromethorphan ANHYDROUS CITRIC ACID DEXTROSE FD&C RED NO. 40 MENTHOL GLYCERIN HIGH FRUCTOSE CORN SYRUP WATER SACCHARIN SODIUM SODIUM BENZOATE GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN"],"spl_unclassified_section":["Questions or comments? Call 201-786-6500 Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DP-UD-PI-AT-[117893] Rev 08/20"],"stop_use":["Stop use and ask a doctor if • your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. • you are hypersensitive to any of the ingredients"],"storage_and_handling":["Other Information • Store at controlled room temperature 20-25ºC (68-77ºF) • Do not refrigerate • Keep tightly closed • Each 5mL contains sodium 3mg • Each 10mL contains sodium 6mg • Fruit punch flavor • Do not use if lid seal is open or damaged • See top of cup for lot number and expiration date"],"version":"6","warnings":["Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug. Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking any other drug Stop use and ask a doctor if • your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. • you are hypersensitive to any of the ingredients 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)"]}