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Paracetamol
Dosage & Duration
Dosage
Doses are population estimates that vary widely between individuals.
Moderate200-500 mg
The maximum recommended daily intake is 4 grams. Exceeding this limit significantly increases the risk of hepatotoxicity.
Duration
Onset60 minutes
After Effects1-2 hours
Total4-6 hours
Subjective Effects
Subjective Effects not written up yet
Pharmacology
Pharmacology not written up yet
Interactions
Interactions not written up yet
An unlisted combination is an unknown one, not a safe one. Check a dedicated combination chart before mixing.
Tolerance
Tolerance not written up yet
Harm Potential
Toxicity
hepatic
Overdose can cause hepatic necrosis, liver failure, and acute liver failure, and prolonged daily use may damage the liver.
renal
Overdose may cause renal tubular necrosis and kidney failure; meta-analyses are described as suggesting increased kidney impairment and kidney cancer risk.
gastrointestinal and hematologic
Higher regular doses are linked to gastrointestinal bleeding, peptic ulcer risk, and bleeding events; overdose may include thrombocytopenia.
cardiovascular
Dose-related adverse-effect summaries include increased mortality and cardiovascular outcomes such as stroke and myocardial infarction; paracetamol may slightly increase blood pressure and heart rate.
dermatologic
Reports note rare skin reactions that may be fatal, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Carcinogenicity
Possible
Carcinogenic activity in female rats and an association with kidney cancer are noted, but confirmed human carcinogenicity is not established.
Evidence Basis
Human EpidemiologicalLimited
Animal Models
Positive
(rat)
History & Culture
History & Culture not written up yet
Legality
International
Paracetamol has approved and investigational status and is commonly available over the counter.
By Country
Legal / decriminalized1
United StatesLegal (regulated)OTC Monograph M013—Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Federal Food, Drug, and Cosmetic Act § 503(b) (21 U.S.C. § 353(b)); and current FDA Structured Product Labels123456
In the United States, acetaminophen is the name used for paracetamol, and its federal marketing status depends on the product and dosage form. Oral acetaminophen products, including Tylenol Extra Strength 500 mg tablets, are marketed over the counter under FDA OTC Monograph M013. Acetaminophen injection is marketed as a prescription product; under 21 U.S.C. § 353(b), a drug limited by its approved application to professional supervision may be dispensed only by prescription. Federal classification is product- and dosage-form-specific and does not determine state, district, territorial, tribal, or local requirements.
References
Citations
- Acetaminophen | FDA. fda.gov (n.d.). https://www.fda.gov/drugs/safe-use-over-counter-pain-relievers-and-fever-reducers/acetaminophen1
- openFDA National Drug Code record — Tylenol Extra Strength 500 mg oral tablet. api.fda.gov (n.d.). https://api.fda.gov/drug/ndc.json?search=product_ndc%3A%2250580-108%22&limit=11
- openFDA National Drug Code query — oral acetaminophen products under M013. api.fda.gov (n.d.). https://api.fda.gov/drug/ndc.json?search=active_ingredients.name%3AACETAMINOPHEN%20AND%20application_number%3AM013%20AND%20route%3AORAL&limit=11
- DailyMed — TYLENOL EXTRA STRENGTH, acetaminophen 500 mg tablet. dailymed.nlm.nih.gov (n.d.). https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3f653262-b931-7d42-e063-6394a90adddd1
- DailyMed — ACETAMINOPHEN injection, solution. dailymed.nlm.nih.gov (n.d.). https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1c8fef8f-2ff5-4bea-bccb-90c2c8544c21&version=31
- 21 U.S.C. § 353 — Exemptions and consideration for certain drugs, devices, and biological products. uscode.house.gov (n.d.). https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title21-section353&num=0&edition=prelim1
Article Status
Step 1 · Automated synthesisAn autonomous workflow built by Josie Kins compiled this article's foundation from information published across the web.
- Step 2 · First-pass reviewPending
Not yet reviewed — this article is pending editorial review by Lyrea.
- Step 3 · Citation reviewPending
No one has reviewed this article's citations yet. That second pass checks each claim against the source it cites.
Recent changes7 human edits · latest
Times are UTCNewest first
24 January 2026
Josie Kins · Updated the article · also 1,4-Butanediol, 1B-LSD, 1cP-AL-LAD and 573 more
Josie Kins · Updated the article · also 1,4-Butanediol, 1B-LSD, 1cP-AL-LAD and 573 more
Josie Kins · Updated the article · also 1,4-Butanediol, 1B-LSD, 1cP-AL-LAD and 573 more
Josie Kins · Updated the article · also 1,4-Butanediol, 1B-LSD, 1cP-AL-LAD and 573 more
Josie Kins · Updated the article · also 1,4-Butanediol, 1B-LSD, 1cP-AL-LAD and 573 more
Josie Kins · Updated the article · also 1,4-Butanediol, 1B-LSD, 1cP-AL-LAD and 573 more
Josie Kins · Updated the article · also 1,4-Butanediol, 1B-LSD, 1cP-AL-LAD and 573 more
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