{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 39 } }, "results": [ { "spl_product_data_elements": [ "WALGREEN ADULT COUGH PLUS CHEST CONGESTION DM dextromethorphan hydrobromide and guaifenesin ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERIN POTASSIUM CITRATE PROPYLENE GLYCOL MENTHOL, UNSPECIFIED FORM WATER SODIUM BENZOATE SUCRALOSE XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN" ], "active_ingredient": [ "Active ingredients (in each 20 ml) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg Purposes Cough suppressant Expectorant" ], "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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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 at 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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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 at 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 7 mg store at room temperature. Do not refrigerate." ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, disodium edetate, flavors, glycerin, potassium citrate, propylene glycol, menthol, purified water, sodium benzoate, sucralose, xanthan gum" ], "questions": [ "Questions or comments? 1-866-467-2748" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Compare to the active ingredients in Dye-Free Sugar-Free Adult Robitussin Cough + Chest Congestion DM* NDC 0363-7440-08 DYE-FREE Adult Cough+Chest Congestion DM Dextromethorphan HBr (Cough Suppressant) Guaifenesin (Expectorant) Controls Cough Relieves Chest Congestion Thins & Loosens Mucus Sugar-Free No Added Alcohol Specially Formulated for DIABETICS Cherry Menthol Flavor For Ages 12 & Over 8 FL OZ (237 ml) *This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark DYE-FREE Sugar-Free Adult Robitussin Cough+chest Congestion DM. Walgreen Adult Cough+Chest Congestion DM 237 ml" ], "set_id": "02ad9f98-07ad-4786-a1ab-169b870fec01", "id": "447d2fe6-3c46-994d-e063-6394a90a2c9c", "effective_time": "20251126", "version": "4", "openfda": { "application_number": [ "M012" ], "brand_name": [ "WALGREEN ADULT COUGH PLUS CHEST CONGESTION DM" ], "generic_name": [ "DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN" ], "manufacturer_name": [ "WALGREEN COMPANY" ], "product_ndc": [ "0363-7440" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROMETHORPHAN HYDROBROMIDE", "GUAIFENESIN" ], "rxcui": [ "1790650" ], "spl_id": [ "447d2fe6-3c46-994d-e063-6394a90a2c9c" ], "spl_set_id": [ "02ad9f98-07ad-4786-a1ab-169b870fec01" ], "package_ndc": [ "0363-7440-08" ], "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" ] } } ] }