{"hq_id":"hq-p-bdy-000128","name":"Acetaminophen / Tylenol (Liver Toxicity, #1 Acute Liver Failure)","category":{"primary":"personal_care","secondary":"medication","tags":["acetaminophen","Tylenol","paracetamol","liver","hepatotoxicity","overdose","pediatric dosing"]},"product_tier":"BDY","overall_risk_level":"moderate","description":"Acetaminophen (paracetamol) — the most widely used OTC analgesic/antipyretic. #1 cause of acute liver failure in the US (~500 deaths/year). Therapeutic dose (≤4g/day adults) is only 2-3x below hepatotoxic threshold. 50% of acetaminophen overdoses are unintentional — from combining multiple products containing acetaminophen (NyQuil + Tylenol + prescription Vicodin). Pediatric dosing errors are common due to multiple formulations (infant drops vs children's liquid) with different concentrations.","synthesis":{"derived_risk_level":"moderate_to_high","synthesis_confidence":0.86,"synthesis_method":"compound_composition","context_used":"human_infant","context_source":"product_users","exposure_modifier":0.977,"vulnerability_escalated":true,"escalation_reason":"Infant exposure group","compounds_resolved":1,"compounds_total":1,"synthesis_date":"2026-03-27","synthesis_version":"1.0.0"},"hazard_summary":{"sensitive_populations":"heavy alcohol users, liver disease patients, children (dosing errors)","overall_risk":"moderate","primary_concerns":["#1 cause of acute liver failure in the US (~500 deaths/year)","50% of overdoses are unintentional (combining products)","Therapeutic dose only 2-3x below hepatotoxic threshold","Pediatric dosing confusion between formulation concentrations"],"exposure_routes":"Oral ingestion"},"exposure":{"routes":["oral"],"contact_types":["oral_direct"],"users":["adult","child","infant"],"duration":"minutes","frequency":"daily","scenarios":["Unintentional overdose from combining multiple acetaminophen products","Pediatric dosing errors between infant drops and children's liquid","Alcohol + acetaminophen: synergistic hepatotoxicity","Maximum 4g/day — only 2-3x below hepatotoxic threshold"],"notes":"FDA 2011: limited prescription acetaminophen to 325mg per tablet. OTC: max 1000mg/dose, 4g/day. ~500 deaths/year from acetaminophen liver failure. ALWAYS check ingredients of ALL medications for acetaminophen content before taking Tylenol separately."},"consumer_guidance":{"usage_warning":"Check ALL medications for acetaminophen before combining. Never exceed 4g/day (3g/day if drinking alcohol). Use weight-based dosing for children. Do not combine Tylenol with NyQuil, DayQuil, Vicodin, Percocet (all contain acetaminophen).","safer_alternatives":["Ibuprofen for pain (different mechanism, no liver toxicity at therapeutic doses)","NSAIDs for inflammation (acetaminophen has no anti-inflammatory effect)","Non-pharmacological: ice, heat, rest, physical therapy"],"red_flags":[{"indicator":"Health claims without FDA approval or clinical evidence","meaning":"Product efficacy unverified.","action":"Consult physician. Check FDA and clinical trial evidence."}],"green_flags":[{"indicator":"FDA-approved, USP-verified, or physician-recommended","meaning":"Verified safety and/or efficacy through established evaluation.","verification":"Check FDA approval status, USP mark, or published clinical evidence."}],"what_to_ask":[{"question":"Is there FDA-approved or peer-reviewed clinical evidence for this product?","why_it_matters":"Health products without evidence may be ineffective or harmful.","good_answer":"FDA-approved or supported by published RCTs.","bad_answer":"Testimonials only or DSHEA-exempt supplement with no clinical evidence."}],"alternatives":[{"name":"Ibuprofen for pain","notes":"different mechanism, no liver toxicity at therapeutic doses"},{"name":"NSAIDs for inflammation","notes":"acetaminophen has no anti-inflammatory effect"},{"name":"Non-pharmacological: ice, heat, rest, physical therapy","notes":"Alternative"}]},"regulatory":{"applicable_regulations":[{"jurisdiction":"USA","regulation":"FDA OTC Monograph (Acetaminophen)","citation":"21 CFR 343","requirements":"Max single dose 1000mg, max daily dose 4000mg. Liver warning required on label.","compliance_status":null,"effective_date":null,"enforcing_agency":"FDA","penalties":null,"source_ref":null}],"certifications":[],"labeling":{"required_disclosures":[],"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":"DEA take-back or mix with coffee grounds in sealed container.","hazardous_waste":false,"expected_lifespan":"2-3_years"},"formulation":{"form":"varies","key_ingredients":[{"hq_id":"hq-c-org-000025","name":"Acetaminophen (APAP)","role":"active_ingredient","concentration_pct":"325-1000 mg/dose"}],"certifications":[]},"materials":{"common":[],"concerning":[],"preferred":[]},"compound_composition":[{"hq_id":"hq-c-org-000025","compound_name":null,"role":"active_ingredient","typical_concentration":"325-1000 mg/dose"}],"identifiers":{"common_names":["acetaminophen / tylenol (liver toxicity, #1 acute liver failure)"],"aliases":[],"manufacturer":null,"brands":[]},"brand_examples":[{"brand":"Johnson & Johnson","manufacturer":"J&J","market_position":"mass_market","notable":"Broad personal care portfolio"},{"brand":"Unilever","manufacturer":"Unilever","market_position":"mass_market","notable":"Global personal care conglomerate"},{"brand":"Procter & Gamble","manufacturer":"P&G","market_position":"mass_market","notable":"Personal care market leader"}],"sources":[{"type":"expert_curation","name":"ALETHEIA Safety Database","date":"2026-03-25"},{"type":"regulation","title":"FDA OTC Monograph (Acetaminophen) (21 CFR 343)","jurisdiction":"USA","citation":"21 CFR 343","id":"src_221ac884"},{"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"}],"meta":{"schema_version":"4.0.0","last_updated":"2026-03-25","timestamp":"2026-05-02T18:16:45.268Z"}}