{ "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": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Tussin DM Tussin DM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE XANTHAN GUM" ], "active_ingredient": [ "Active ingredient(s) Dextromethorphan HBr 10 mg Guaifenesin 100 mg (In each 5mL)" ], "purpose": [ "Purpose Cough Suppressant Expectorant" ], "indications_and_usage": [ "Use(s) 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 • 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. Do not exceed recommended dosage If pregnant or breastfeeding, 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 (1-800-222-1222) right away." ], "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 • 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 breastfeeding, 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 (1-800-222-1222) right away." ], "dosage_and_administration": [ "Directions • do not take more than 6 doses in any 24 hour period • this adult strength product is not intended for use in children under 12 years of age • measure only with dosing cup provided • keep dosing cup with product • TSP=teaspoon • mL=milliliter • dose as follows: Age Dose adults and children 12 years and over 10 mL (2 Teaspoonfuls) every 4 hours children under 12 years do not use" ], "dosage_and_administration_table": [ "
AgeDose
adults and children12 years and over10 mL (2 Teaspoonfuls) every 4 hours
children under 12 yearsdo not use
" ], "spl_unclassified_section": [ "Other information • store at 15-30°C (59-86°F). Do not refrigerate • alcohol-free • see bottom panel for lot number and expiration date. DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING." ], "inactive_ingredient": [ "Inactive ingredients Anhydrous citric acid, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum." ], "questions": [ "Questions/Comments Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)" ], "package_label_principal_display_panel": [ "Principal Display Panel Tussin Label Tussin Carton Tussin Label Tussin Carton" ], "set_id": "7a2f8d48-3123-4c37-b238-bd7cc4242bb7", "id": "53118f5e-94a1-49e0-bd02-afb510782757", "effective_time": "20250723", "version": "3", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Tussin DM" ], "generic_name": [ "TUSSIN DM" ], "manufacturer_name": [ "Allegiant Health" ], "product_ndc": [ "69168-477" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROMETHORPHAN HYDROBROMIDE", "GUAIFENESIN" ], "rxcui": [ "996520" ], "spl_id": [ "53118f5e-94a1-49e0-bd02-afb510782757" ], "spl_set_id": [ "7a2f8d48-3123-4c37-b238-bd7cc4242bb7" ], "package_ndc": [ "69168-477-66" ], "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" ] } } ] }