{ "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": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Acetaminophen, Dextromethorphan HBr, Pseudoephedrine HCl ALCOHOL ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE Clear" ], "active_ingredient": [ "Active ingredients (in each 30 mL) Acetaminophen 1000 mg Dextromethorphan HBr 30 mg Pseudoephedrine HCl 60 mg" ], "purpose": [ "Purposes Pain reliever/Fever reducer Cough suppressant Nasal decongestant" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a common cold or flu: headache minor aches and pains minor sore throat pain cough due to minor throat and bronchial irritation nasal and sinus congestion temporarily reduces fever" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. Do not use in a child under 12 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs pain, cough or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "do_not_use": [ "Do not use in a child under 12 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "when_using": [ "When using this product do not exceed recommended dosage" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs pain, cough or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions do not use more than directed measure the dose correctly using the enclosed dosing cup adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 30 mL every 6 hours children under 12 years of age do not use" ], "dosage_and_administration_table": [ "
AgeDose
adults and children 12 years of age and over30 mL every 6 hours
children under 12 years of agedo not use
" ], "spl_unclassified_section": [ "Other information each 30 mL contains : sodium 26 mg store at 20-25°C (68-77°F). Do not refrigerate. Keep bottle tightly closed." ], "inactive_ingredient": [ "Inactive ingredients alcohol, anhydrous citric acid, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose" ], "questions": [ "Questions or comments? 1-855-328-5259" ], "other_safety_information": [ "Additional Information READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org DO NOT USE IF TEAR BAND ON CAP IS BROKEN OR MISSING. Distributed by: Haleon Warren, NJ 07059 Made in Canada ©2024 Haleon group of companies or its licensor. Trademarks are owned by or licensed to the Haleon group of companies. Pat. Info www.productpats.com" ], "package_label_principal_display_panel": [ "Principal Display Panel MULTI-SYMPTOM RELIEF NEW HALEON THERAFLU-D FLU RELIEF MAX STRENGTH* + NASAL DECONGESTANT Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant Pseudoephedrine HCI Nasal Decongestant Fast, Powerful Multi-Symptom relief of: / Fever / Nasal congestion / Sinus Pressure / Head & Body Ache / Sore Throat Pain / Cough Cherry Flavor 8.0 FL OZ (237 mL) 62000000209289 Carton Theraflu-D Flu Relief MS Nasal Decon 8.0 fl oz" ], "set_id": "e35cb719-9e7d-4b2b-81a4-29e147dd74fa", "id": "178df809-0bd7-7259-e063-6294a90a2b21", "effective_time": "20240503", "version": "1", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Theraflu-D Flu Relief Max Strength plus Nasal Decongestant" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL" ], "manufacturer_name": [ "Haleon US Holdings LLC" ], "product_ndc": [ "0067-0115" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "rxcui": [ "1369927" ], "spl_id": [ "178df809-0bd7-7259-e063-6294a90a2b21" ], "spl_set_id": [ "e35cb719-9e7d-4b2b-81a4-29e147dd74fa" ], "package_ndc": [ "0067-0115-01" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "6V9V2RYJ8N" ] } } ] }