{"hq_id":"hq-p-bdy-000105","name":"Cold medicine (multi-symptom liquid, adult)","category":{"primary":"personal_care","secondary":"OTC oral medicine","tags":["cold medicine","acetaminophen","dextromethorphan","OTC","multi-symptom"]},"product_tier":"BDY","overall_risk_level":"moderate","description":"OTC multi-symptom cold/flu liquid formulation containing acetaminophen (analgesic/antipyretic), dextromethorphan (cough suppressant), phenylephrine (nasal decongestant), and propylene glycol/alcohol as vehicle. CRITICAL SAFETY ISSUE: acetaminophen hepatotoxicity. Acetaminophen is the leading cause of acute liver failure in the US (~56,000 ER visits/year). Maximum daily dose is 3,000-4,000 mg; accidental overdose occurs when patients take multiple acetaminophen-containing products simultaneously. Liquid formulations increase dosing error risk.","synthesis":{"derived_risk_level":"low","synthesis_confidence":0.82,"synthesis_method":"compound_composition","context_used":"human_adult","context_source":"product_users","exposure_modifier":1,"vulnerability_escalated":false,"escalation_reason":null,"compounds_resolved":2,"compounds_total":2,"synthesis_date":"2026-03-27","synthesis_version":"1.0.0"},"hazard_summary":{"sensitive_populations":"child, adolescent, chronic alcohol users","overall_risk":"moderate","primary_concerns":["Hepatotoxicity: acetaminophen overdose causes acute liver failure; #1 cause in US","Accidental overdose: acetaminophen hidden in 600+ products; cumulative dosing","DXM abuse: recreational misuse for dissociative effects, especially adolescents","Drug interactions: DXM + SSRIs → serotonin syndrome risk"],"exposure_routes":"oral"},"exposure":{"routes":["ingestion"],"contact_types":["oral_direct"],"users":["adult"],"duration":"short_term","frequency":"every_4-6_hours","scenarios":["Accidental acetaminophen overdose from multiple products (cold medicine + Tylenol + prescription combo)","DXM recreational misuse (especially adolescents)","Dosing error with liquid formulation (incorrect measuring cup)"],"notes":"Acetaminophen is present in 600+ OTC and prescription products. Patients often unknowingly take multiple acetaminophen sources."},"consumer_guidance":{"red_flags":[{"indicator":"Taking multiple products containing acetaminophen","meaning":"Cumulative overdose risk — hepatotoxicity","action":"Check ALL medications for acetaminophen (also listed as APAP) before combining"}],"green_flags":[{"indicator":"Single-ingredient products","meaning":"Reduces accidental acetaminophen stacking","verification":"Use single-ingredient cold products instead of multi-symptom combos"}],"what_to_ask":[],"alternatives":[{"name":"Single-ingredient cold products","notes":"Target specific symptoms; reduces accidental acetaminophen overdose risk"},{"name":"Ibuprofen-based cold products (no acetaminophen)","notes":"Alternative analgesic/antipyretic; no hepatotoxicity risk; GI/cardiovascular concerns instead"}],"notes":null},"regulatory":{"applicable_regulations":[{"jurisdiction":"USA","regulation":"FDA OTC Drug Monograph","citation":null,"requirements":"FDA-regulated OTC drug. 2011 FDA advisory limited single-dose acetaminophen to 325mg in Rx combos.","compliance_status":null,"effective_date":null,"enforcing_agency":"FDA","penalties":null,"source_ref":null}],"certifications":[],"labeling":{"required_disclosures":["Drug Facts label","Acetaminophen liver warning","Alcohol warning"],"prop65_warning":{"required":null,"chemicals":[],"endpoint":null,"notes":null},"ghs_labeling":{"required":null,"signal_word":null,"pictograms":[],"hazard_statements":[],"notes":null},"hidden_ingredients":{"trade_secret_protected":null,"categories_hidden":[],"estimated_count":null,"known_concerns":null,"notes":null},"notes":null},"recalls":[],"regulatory_gap":null,"notes":null},"lifecycle":{"recyclable":true,"disposal_guidance":"Drug take-back program or FDA disposal guidelines","hazardous_waste":false,"expected_lifespan":"2-3_years"},"formulation":{"form":"liquid_oral","key_ingredients":[{"hq_id":"hq-c-org-000025","name":"Acetaminophen (APAP)","role":"analgesic_antipyretic","concentration_pct":"6.5"},{"hq_id":"hq-c-org-000295","name":"Dextromethorphan HBr (DXM)","role":"cough_suppressant","concentration_pct":"1.0"},{"hq_id":null,"name":"Phenylephrine HCl","role":"nasal_decongestant","concentration_pct":"0.5"},{"hq_id":"hq-c-org-000094","name":"Propylene glycol","role":"solvent_vehicle","concentration_pct":"10-20"},{"hq_id":null,"name":"Sucrose / sorbitol","role":"sweetener","concentration_pct":"20-40"},{"hq_id":null,"name":"FD&C dyes (Red 40, Blue 1)","role":"colorant","concentration_pct":"trace"}],"certifications":[]},"materials":{"common":[],"concerning":[],"preferred":[]},"compound_composition":[{"hq_id":"hq-c-org-000025","compound_name":"Acetaminophen (APAP)","role":"analgesic","typical_concentration":null},{"hq_id":"hq-c-org-000295","compound_name":"Dextromethorphan (DXM)","role":"antitussive","typical_concentration":null}],"identifiers":{"common_names":["cold medicine","cold and flu liquid","multi-symptom cold relief","nighttime cold medicine"],"aliases":[],"manufacturer":null,"brands":[]},"brand_examples":[{"brand":"Generic Mass-Market Brand A","manufacturer":"Consumer Products Corporation","market_position":"mass_market","notable":"Widely available mass-market option"},{"brand":"Generic Mass-Market Brand B","manufacturer":"Consumer Goods Ltd","market_position":"mass_market","notable":"Popular budget alternative"},{"brand":"Premium Brand A","manufacturer":"Premium Consumer Inc","market_position":"premium","notable":"Upscale premium positioning"}],"sources":[{"type":"expert_curation","name":"ALETHEIA Safety Database","date":"2026-03-24"},{"type":"regulation","title":"FDA OTC Drug Monograph","jurisdiction":"USA","id":"src_f7c3cf79"},{"id":"fda_apap_labeling","type":"regulatory","title":"FDA: Acetaminophen (APAP) OTC Drug Facts Labeling and Safety Review","year":2023,"inherited_from_compound":"hq-c-org-000025"},{"id":"aspca_apap","type":"report","title":"ASPCA Animal Poison Control Center: Acetaminophen Toxicity in Pets","year":2021,"inherited_from_compound":"hq-c-org-000025"},{"id":"fda_dxm_safety_2010","type":"regulatory","title":"FDA Drug Safety Communication: DXM Cough Suppressants — Not for children <4 years; CYP2D6 poor metabolizer drug interaction; serotonin syndrome risk; adolescent abuse robotripping; Coricidin HBP triple-C abuse; NMDA antagonism high dose (2010)","year":2010,"inherited_from_compound":"hq-c-org-000295"},{"id":"aapcc_annual_2022","type":"regulatory","title":"American Association of Poison Control Centers (AAPCC): National Poison Data System Annual Report — Pediatric cocaine/stimulant exposures; body packing emergencies; levamisole agranulocytosis; accidental child ingestion outcomes (2022)","year":2022,"inherited_from_compound":"hq-c-org-000295"}],"meta":{"schema_version":"4.0.0","last_updated":"2026-03-24","timestamp":"2026-05-02T18:17:58.811Z"}}