{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "tussin cough chest congestion Dextromethorphan Hydrobromide, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ACETIC ACID ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MENTHOL, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SOLUTION SUCRALOSE XANTHAN GUM" ], "active_ingredient": [ "Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg" ], "purpose": [ "Purposes Cough suppressant Expectorant" ], "indications_and_usage": [ "Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes" ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 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 Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222)." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "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" ], "stop_use": [ "Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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)." ], "dosage_and_administration": [ "Directions • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use" ], "dosage_and_administration_table": [ "
agedose
adults and children 12 years and over20 mL every 4 hours
children under 12 yearsdo not use
" ], "storage_and_handling": [ "Other information • each 20 mL contains: sodium 13 mg • store at 20-25°C (68-77°F). Do not refrigerate." ], "inactive_ingredient": [ "Inactive ingredients acetic acid, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Compare to the active ingredients in Robitussin ® Maximum Strength Cough + Chest Congestion DM FREE FROM GLUTEN FREE ALCOHOL FREE MAXIMUM STRENGTH TUSSIN COUGH + CHEST CONGESTION DEXTROMETHORPHAN HBr COUGH SUPPRESSANT GUAIFENESIN/EXPECTORANT ADULT • NON-DROWSY Relieves chest congestion, controls cough, thins & loosens mucus For ages 12 & over DM MAX RASPBERRY MENTHOL FLAVOR 4 FL OZ (118 mL) 2b7-83-tussin-cough-chest-congestion.jpg" ], "set_id": "86fc3723-5fc5-4de5-bd04-7774c2abe539", "id": "7b476b20-4729-44c7-880c-ad73fbf93ef8", "effective_time": "20260904", "version": "4", "openfda": { "application_number": [ "M012" ], "brand_name": [ "tussin cough chest congestion" ], "generic_name": [ "DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN" ], "manufacturer_name": [ "Rite Aid Corporation" ], "product_ndc": [ "11822-1332" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROMETHORPHAN HYDROBROMIDE", "GUAIFENESIN" ], "rxcui": [ "1020138" ], "spl_id": [ "7b476b20-4729-44c7-880c-ad73fbf93ef8" ], "spl_set_id": [ "86fc3723-5fc5-4de5-bd04-7774c2abe539" ], "package_ndc": [ "11822-1332-1", "11822-1332-2" ], "is_original_packager": [ true ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "9D2RTI9KYH", "495W7451VQ" ] } } ] }