{"id":"dextromethorphan-hydrobromide","_fda":{"id":"4215aa5e-a436-4ebe-bf6d-18301730b460","set_id":"0100f86e-257f-4197-9849-3c4429cdf0f2","openfda":{"nui":["N0000193956","N0000008867","N0000009560"],"unii":["362O9ITL9D","9D2RTI9KYH","495W7451VQ","04JA59TNSJ"],"route":["ORAL"],"rxcui":["1369842"],"spl_id":["4215aa5e-a436-4ebe-bf6d-18301730b460"],"brand_name":["basic care daytime severe cold and flu"],"spl_set_id":["0100f86e-257f-4197-9849-3c4429cdf0f2"],"package_ndc":["72288-603-40","72288-603-34"],"product_ndc":["72288-603"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"product_type":["HUMAN OTC DRUG"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"pharm_class_epc":["Expectorant [EPC]"],"manufacturer_name":["Amazon.com Services LLC"],"application_number":["M012"],"is_original_packager":[true]},"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant"],"version":"4","stop_use":["Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • 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."],"warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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 • 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. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • heart disease • thyroid disease • diabetes • high blood pressure • 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, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"questions":["Questions? 1-800-719-9260"],"ask_doctor":["Ask a doctor before use if you have • liver disease • heart disease • thyroid disease • diabetes • high blood pressure • 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, chronic bronchitis, or emphysema"],"do_not_use":["Do not use • 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. • if you have ever had an allergic reaction to this product or any of its ingredients"],"when_using":["When using this product do not use more than directed"],"effective_time":"20241028","active_ingredient":["Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg"],"inactive_ingredient":["Inactive ingredients butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum Questions? 1-800-719-9260"],"storage_and_handling":["Other information • each 15 mL contains: sodium 6 mg • store at 20-25 ° C (68-77 ° F). Do not refrigerate."],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin"],"dosage_and_administration":["Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use Other information • each 15 mL contains: sodium 6 mg • store at 20-25 ° C (68-77 ° F). Do not refrigerate."],"spl_product_data_elements":["basic care daytime severe cold and flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BUTYLATED HYDROXYANISOLE EDETATE DISODIUM FD&C YELLOW NO. 6 GLYCERIN MENTHOL, UNSPECIFIED FORM SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SACCHARIN SODIUM SUCROSE XANTHAN GUM clear"],"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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"dosage_and_administration_table":["
adults & children 12 yrs & over30 mL every 4 hrs
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsask a doctor
children under 4 yrsdo not use
"],"package_label_principal_display_panel":["Package/Label Principal Display Panel amazon basic care Multi-Symptom Relief Compare to Vicks ® DayQuil ® Severe active ingredients Non-Drowsy Daytime Severe Cold & Flu Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl Pain Reliever/Fever Reducer Nasal Decongestant Cough Suppressant Expectorant Original Flavor ALCOHOL FREE 12 FL OZ (355 mL) 603-bn-daytime-severe-cold-and-flu"]},"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"3391 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"2131 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1680 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1497 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1154 reports"},{"date":"","signal":"OVERDOSE","source":"FDA FAERS","actionTaken":"1103 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"1078 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"1048 reports"},{"date":"","signal":"ACCIDENTAL OVERDOSE","source":"FDA FAERS","actionTaken":"970 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"970 reports"}],"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL1256818","moleculeType":"Small molecule","molecularWeight":"370.33"},"_fixedAt":"2026-03-30T16:52:10.117385","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DEXTROMETHORPHAN HYDROBROMIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T04:43:56.102310+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T04:44:47.855670+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T04:44:02.300866+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T04:43:54.729100+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DEXTROMETHORPHAN HYDROBROMIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T04:44:02.958213+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:43:53.095566+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:43:53.095618+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:44:42.837929+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:43:53.095631+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T04:44:05.126108+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Glutamate [NMDA] receptor subunit epsilon 1 antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:44:04.183303+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1256818/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:44:04.088707+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M012","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:43:53.095640+00:00"}},"_dailymed":{"setId":"015b47e1-4afe-48a3-86ff-06f404d48ad5","title":"NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [THE KROGER CO.]"},"aiSummary":"Dextromethorphan Hydrobromide is a marketed drug primarily indicated for nasal congestion relief, with a key composition patent expiring in 2028. Its primary strength lies in its established market presence and long-standing use for nasal congestion. The primary risk is the potential increase in competition following the patent expiry in 2028.","mechanism":{"modality":"Small Molecule","drugClass":"Expectorant [EPC]"},"_scrapedAt":"2026-03-27T23:44:38.267Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T04:44:47.855720+00:00","fieldsConflicting":1,"overallConfidence":0.8},"indications":{"approved":[{"id":"dextromethorphan-hydrobromide-nasal-congestion-relief","name":"Nasal Congestion Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with nasal congestion","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with nasal congestion","diagnosticRequired":null,"brandNameForIndication":""},{"id":"dextromethorphan-hydrobromide-sinus-congestion-and-pressure-","name":"Sinus Congestion and Pressure Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with sinus congestion and pressure","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with sinus congestion and pressure","diagnosticRequired":null,"brandNameForIndication":""},{"id":"dextromethorphan-hydrobromide-cough-relief","name":"Cough Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with cough due to minor throat and bronchial irritation","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with cough due to minor throat and bronchial irritation","diagnosticRequired":null,"brandNameForIndication":""},{"id":"dextromethorphan-hydrobromide-pain-relief","name":"Pain Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with minor aches and pains","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with minor aches and pains","diagnosticRequired":null,"brandNameForIndication":""},{"id":"dextromethorphan-hydrobromide-headache-relief","name":"Headache Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with headache","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with headache","diagnosticRequired":null,"brandNameForIndication":""},{"id":"dextromethorphan-hydrobromide-fever-reduction","name":"Fever Reduction","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with fever","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with fever","diagnosticRequired":null,"brandNameForIndication":""},{"id":"dextromethorphan-hydrobromide-sore-throat-relief","name":"Sore Throat Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with sore throat","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with sore throat","diagnosticRequired":null,"brandNameForIndication":""},{"id":"dextromethorphan-hydrobromide-reduction-of-nasal-swelling","name":"Reduction of Nasal 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congestion","diagnosticRequired":null,"brandNameForIndication":""},{"id":"dextromethorphan-hydrobromide-phlegm-loosening","name":"Phlegm Loosening","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with phlegm and thick bronchial secretions","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with phlegm and thick bronchial secretions","diagnosticRequired":null,"brandNameForIndication":""},{"id":"dextromethorphan-hydrobromide-productive-cough-promotion","name":"Productive Cough Promotion","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with non-productive coughs","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with non-productive coughs","diagnosticRequired":null,"brandNameForIndication":""}]},"_fixedFields":["sideEffects","modality→Small Molecule"],"trialDetails":[{"nctId":"NCT05278494","phase":"NA","title":"Dextromethorphan for Treatment of Postoperative 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