{"id":"chembl-chembl52440","_fda":{"id":"3aa48604-afd3-49a2-b0a8-ab15171c7913","set_id":"0044c53c-11dd-41a9-a5d9-622dd8b1c144","openfda":{"upc":["0032251921049"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"],"route":["ORAL"],"rxcui":["1113705"],"spl_id":["3aa48604-afd3-49a2-b0a8-ab15171c7913"],"brand_name":["Daytime Cold and Flu"],"spl_set_id":["0044c53c-11dd-41a9-a5d9-622dd8b1c144"],"package_ndc":["55319-960-08"],"product_ndc":["55319-960"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL"],"product_type":["HUMAN OTC DRUG"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"manufacturer_name":["Family Dollar (FAMILY WELLNESS)"],"application_number":["M012"],"is_original_packager":[true]},"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"version":"3","stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 a rash or headache that lasts. These could be signs of a serious condition."],"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 inclide: 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 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough 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 occur 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 a 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"questions":["Questions or comments? Call 1 -877-753-3935 Monday-Friday 9AM-5PM EST"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema"],"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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"when_using":["When using this product, do not exceed recommended dosage"],"effective_time":"20240327","active_ingredient":["Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg"],"inactive_ingredient":["Inactive ingredients acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate"],"indications_and_usage":["Uses temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin."],"other_safety_information":["Other information each 30 mL contains : sodium 16 mg store between 20-25ºC (68-77ºF). Do not refrigerate."],"dosage_and_administration":["Directions do not take more than directed (see overdose warning ) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours chlldren under 12 years of age: do not use"],"spl_product_data_elements":["Daytime Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ALCOHOL ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE"],"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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["Principal Display Panel COMPARE TO THE ACTIVE INGREDIENTS IN THERAFLU® EXPRESSMAX® DAYTIME SEVERE COLD & COUGH* ADULT DAYTIME SEVERE COLD & COUGH RELIEF Acetaminophen 650 mg Pain reliever; Fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCI 10 mg Nasal decongestion RELIEVES Cough Nasal congestion Sore throat Fever Body ache Headache Alcohol 10% For Ages 12 Years & Older BERRY FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® ExpressMax® Daytime Severe Cold & Cough. DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PKWY, CHESAPEAKE, VA 23320","Product Label FAMILY WELLNESS Adult Daytime Severe Cold & Cough Relief Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg"]},"safety":{"boxedWarnings":[]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DEXTROMETHORPHAN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T04:30:11.355464+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T04:30:16.230422+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DEXTROMETHORPHAN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T04:30:16.444278+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA 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symptoms","diagnosticRequired":null,"brandNameForIndication":""},{"id":"chembl-chembl52440-fever-reduction","name":"Fever reduction","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with fever","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with fever","diagnosticRequired":null,"brandNameForIndication":""}]},"trialDetails":[{"nctId":"NCT05278494","phase":"NA","title":"Dextromethorphan for Treatment of Postoperative Pain","status":"RECRUITING","sponsor":"Nathanael Heckmann","startDate":"2022-09-15","conditions":"Post-operative Pain","enrollment":160},{"nctId":"NCT05068791","phase":"EARLY_PHASE1","title":"Psilocybin-facilitated Treatment for Chronic Pain","status":"RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2023-11-01","conditions":"Fibromyalgia, Primary","enrollment":30},{"nctId":"NCT06566794","phase":"NA","title":"KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug 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