Acetaminophen
Allay, Anexsia, Anoquan, Apadaz, Bancap, Bucet, Butapap, Co-gesic, Codrix, Combogesic, Darvocet, Dhc, Dolene Ap, Drixoral, Empracet, Esgic, Excedrin (migraine Relief), Femcet, Feverall, Fioricet, Hy-phen, Lorcet-hd, Lortab, Medigesic, Norcet, Norco, Papeine, Percocet, Phenaphen, Phrenilin, Propacet, Proval, Roxicet, Roxilox, Sedapap, Synalgos-dc-a, Talacen, Tavist, Tencon, Triad, Triaprin, Tycolet, Tylenol, Tylox, Ultracet, Vicodin, Wygesic, Xartemis, Zydone, Zyfrel (acetaminophen) is a small molecule pharmaceutical. Acetaminophen was first approved as Acephen on 1982-01-01. It is used to treat fever and pain in the USA. It is known to target prostaglandin G/H synthase 2 and prostaglandin G/H synthase 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Acephen, Feverall, Tylenol (generic drugs available since 1982-01-01, discontinued: Injectapap, Neopap, Ofirmev)
CombinationsCombogesic, Excedrin (migraine relief), Fioricet (generic drugs available since 1982-01-01, discontinued: Allay, Anexsia, Anoquan, Apadaz, Bancap, Bucet, Butapap, Co-gesic, Codrix, Darvocet, Darvocet a500, Darvocet-n, Dhc, Dolene ap, Drixoral, Duradyne dhc, Empracet, Esgic, Femcet, Hy-phen, Lorcet-hd, Lortab, Medigesic, Norcet, Norco, Papeine, Percocet, Phenaphen, Phrenilin, Propacet, Proval, Roxicet, Roxilox, Sedapap, Synalgos-dc-a, Talacen, Tavist, Tencon, Triad, Triaprin, Tycolet, Tylenol, Tylox, Ultracet, Vicodin, Wygesic, Xartemis, Zydone, Zyfrel)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acetaminophen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACETAMINOPHEN | B. Braun Medical | N-204957 RX | 2021-02-18 | 2 products, RLD, RS |
| ACEPHEN | Cosette Pharmaceuticals | N-018060 OTC | 1982-01-01 | 1 products |
| ACETAMINOPHEN | Fresenius Kabi | N-204767 RX | 2015-10-28 | 1 products |
| ACETAMINOPHEN | Hikma Pharmaceuticals | N-206968 RX | 2022-06-03 | 1 products, RLD, RS |
| TYLENOL | Johnson & Johnson | N-019872 OTC | 1994-06-08 | 2 products, RLD, RS |
| INFANTS' FEVERALL | Taro Pharmaceutical | N-018337 OTC | 1992-08-26 | 1 products, RLD |
| ACETAMINOPHEN | Taro Pharmaceutical | N-018337 OTC | 1982-01-01 | 3 products, RLD |
Show 6 discontinued
Acetaminophen
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Aspirin
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Caffeine
Acetaminophen
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Benzhydrocodone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| APADAZ | Zevra Therapeutics | N-208653 DISCN | 2018-02-23 | 3 products, RLD |
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Acetaminophen
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Butalbital
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Caffeine
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Codeine phosphate
Acetaminophen
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Clemastine fumarate
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Pseudoephedrine hydrochloride
Acetaminophen
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Dexbrompheniramine maleate
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Pseudoephedrine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DRIXORAL PLUS | Merck Sharp & Dohme | N-019453 DISCN | 1987-05-22 | 1 products |
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Acetaminophen
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Ibuprofen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| COMBOGESIC | AFT Pharmaceuticals | N-209471 RX | 2023-03-01 | 1 products, RLD, RS |
| ADVIL DUAL ACTION WITH ACETAMINOPHEN | GSK | N-211733 OTC | 2020-02-28 | 1 products, RLD, RS |
Acetaminophen
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Oxycodone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XARTEMIS XR | Mallinckrodt | N-204031 DISCN | 2014-03-11 | 1 products, RLD |
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Acetaminophen
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Pentazocine hydrochloride
Acetaminophen
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Propoxyphene hydrochloride
Acetaminophen
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Propoxyphene napsylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DARVOCET-N 50 | Xanodyne Pharmaceuticals | N-017122 DISCN | 1982-01-01 | 1 products |
| DARVOCET-N 100 | Xanodyne Pharmaceuticals | N-017122 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Acetaminophen
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Tramadol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ULTRACET | Johnson & Johnson | N-021123 DISCN | 2001-08-15 | 1 products, RLD |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 10 person ansi | OTC monograph final | 2010-06-07 |
| 24 / 7 life extra strength pain reliever | OTC monograph final | 2023-07-19 |
| 24 / 7 life extra strength pain reliever pm | OTC monograph not final | 2023-07-19 |
| 24/7 life cold and flu daytime severe | OTC monograph final | 2023-07-19 |
| 25 person ansi | OTC monograph final | 2010-06-07 |
| 365 everyday value acetaminophen | OTC monograph not final | 2020-08-24 |
| 4017 first aid kit 4022 first aid kit | unapproved drug other | 2024-01-22 |
| 4056 first aid kit 4068 first aid kit 4081 first aid kit 4082 first aid kit 4083 first aid kit 4084 first aid kit 4085 first aid kit 4086 first aid... | unapproved drug other | 2024-01-22 |
| 4069 first aid kit | unapproved drug other | 2019-03-10 |
| 4076 first aid kit | unapproved drug other | 2019-03-17 |
Show 1874 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| fever | HP_0001945 | D005334 | R50.9 |
| pain | EFO_0003843 | D010146 | R52 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ACETAMINOPHEN / IBUPROFEN, COMBOGESIC, AFT PHARMS LTD | |||
| 2026-03-01 | NP | ||
ACETAMINOPHEN / IBUPROFEN, ADVIL DUAL ACTION WITH ACETAMINOPHEN, GLAXOSMITHKLINE | |||
| 2023-02-28 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Acetaminophen / Ibuprofen, Combogesic, Aft Pharms Ltd | |||
| 11197830 | 2039-02-27 | DP | U-3553 |
| 11534407 | 2039-02-27 | DP | U-3553 |
| 10532036 | 2025-09-22 | U-3553 | |
| Acetaminophen / Oxycodone Hydrochloride, Xartemis Xr, Mallinckrodt Inc | |||
| 8658631 | 2032-05-16 | DP | |
| 8741885 | 2032-05-16 | DP | U-1499 |
| 8992975 | 2032-05-16 | DP | |
| 9050335 | 2032-05-16 | DP | |
| 9468636 | 2032-05-16 | U-1499 | |
| 8597681 | 2030-12-21 | DP | |
| 8980319 | 2030-12-21 | DP | |
| 8377453 | 2029-11-19 | DP | U-1499 |
| 8372432 | 2029-03-11 | DP | U-1499 |
| 8394408 | 2029-03-11 | DP | |
| 8668929 | 2029-03-11 | U-1499 | |
| 7976870 | 2027-06-01 | U-1498 | |
| Acetaminophen, Ofirmev, Mallinckrodt Hosp | |||
| 9399012 | 2031-09-11 | U-2261, U-2262 | |
| 9610265 | 2028-11-13 | U-2263 | |
| 9987238 | 2028-11-13 | U-2261 | |
| 10383834 | 2028-11-13 | U-2262, U-2621 | |
| Acetaminophen / Benzhydrocodone Hydrochloride, Apadaz, Zevra Therap | |||
| 8461137 | 2031-02-22 | DS, DP | |
| 8748413 | 2030-07-10 | DS, DP | |
| 8828978 | 2030-07-01 | DP | |
| 9132125 | 2030-07-01 | DS, DP | U-2249 |
| 9549923 | 2030-07-01 | DS, DP | |
| Acetaminophen, Acetaminophen, Fresenius Kabi Usa | |||
| 8741959 | 2030-04-19 | DP | |
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AJ: Opioids in combination with non-opioid analgesics
— N02AJ01: Dihydrocodeine and paracetamol
— N02AJ06: Codeine and paracetamol
— N02AJ13: Tramadol and paracetamol
— N02AJ17: Oxycodone and paracetamol
— N02B: Other analgesics and antipyretics in atc
— N02BE: Anilide analgesics and antipyretics
— N02BE01: Paracetamol
— N02BE51: Paracetamol, combinations excl. psycholeptics
— N02BE71: Paracetamol, combinations with psycholeptics
HCPCS
Code | Description |
|---|---|
| J0131 | Injection, acetaminophen, 10 mg |
Clinical
Clinical Trials
2186 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 9 | 23 | 45 | 112 | 99 | 285 |
| Pain | D010146 | EFO_0003843 | R52 | 16 | 26 | 37 | 64 | 64 | 202 |
| Healthy volunteers/patients | — | — | — | 46 | — | 1 | 6 | 10 | 63 |
| Acute pain | D059787 | — | R52 | 5 | 7 | 13 | 17 | 21 | 62 |
| Analgesia | D000698 | — | — | 3 | 3 | 10 | 16 | 23 | 54 |
| Low back pain | D017116 | HP_0003419 | M54.5 | 1 | 3 | 14 | 13 | 21 | 52 |
| Fever | D005334 | HP_0001945 | R50.9 | 4 | 7 | 10 | 15 | 9 | 43 |
| Covid-19 | D000086382 | — | U07.1 | 4 | 14 | 14 | 3 | 5 | 35 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 3 | 4 | 9 | 12 | 7 | 34 |
| Anesthesia | D000758 | — | — | 1 | 1 | 6 | 8 | 17 | 33 |
Show 242 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 4 | 6 | 3 | — | 1 | 14 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 4 | 5 | 1 | — | 1 | 9 |
| Lymphoma | D008223 | — | C85.9 | 3 | 5 | 1 | — | — | 8 |
| Acute liver failure | D017114 | HP_0004448 | — | — | 2 | 3 | — | 3 | 7 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 1 | 2 | — | 3 | 6 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | 1 | — | 5 | 6 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 5 | 1 | — | 1 | 6 |
| Dental pins | D003772 | — | — | — | 5 | 1 | — | — | 6 |
| Anterior cruciate ligament injuries | D000070598 | — | — | — | 1 | 2 | — | 3 | 5 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 2 | 3 | — | — | 5 |
Show 85 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety | D001007 | EFO_0005230 | F41.1 | 1 | 2 | — | — | 7 | 10 |
| Leukemia | D007938 | — | C95 | 1 | 5 | — | — | 1 | 7 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | — | 5 | 6 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 6 | — | — | — | 6 |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | — | 3 | — | — | 3 | 6 |
| Graft vs host disease | D006086 | — | D89.81 | 1 | 4 | — | — | — | 5 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | — | — | 3 | 5 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 3 | — | — | — | 4 |
| Hematologic neoplasms | D019337 | — | — | 2 | 1 | — | — | 1 | 4 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 3 | 2 | — | — | — | 4 |
Show 124 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overweight | D050177 | — | E66.3 | 3 | — | — | — | 2 | 5 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | 3 | 4 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | — | — | — | 2 | 3 |
| Therapeutic equivalency | D013810 | — | — | 3 | — | — | — | — | 3 |
| Spondylolisthesis | D013168 | EFO_0007493 | M43.1 | 1 | — | — | — | 2 | 3 |
| Facial pain | D005157 | — | R51.9 | 1 | — | — | — | 2 | 3 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | — | — | — | 1 | 2 |
| Hairy cell leukemia | D007943 | — | C91.4 | 2 | — | — | — | — | 2 |
| Bariatric surgery | D050110 | — | — | 1 | — | — | — | 1 | 2 |
| Liver transplantation | D016031 | EFO_0010682 | — | 1 | — | — | — | 1 | 2 |
Show 30 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tick-borne encephalitis | D004675 | EFO_1001309 | A84 | — | — | — | — | 3 | 3 |
| Vitreoretinal surgery | D057586 | — | — | — | — | — | — | 3 | 3 |
| Pelvic pain | D017699 | — | — | — | — | — | — | 3 | 3 |
| Retinopathy of prematurity | D012178 | EFO_1001158 | H35.1 | — | — | — | — | 3 | 3 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | — | — | — | 3 | 3 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 3 | 3 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 3 | 3 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | — | — | — | 3 | 3 |
| Hemorrhoids | D006484 | EFO_0009552 | K64 | — | — | — | — | 2 | 2 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | — | 2 | 2 |
Show 167 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Acetaminophen |
| INN | paracetamol |
| Description | Paracetamol is a member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group. It has a role as a cyclooxygenase 2 inhibitor, a cyclooxygenase 1 inhibitor, a non-narcotic analgesic, an antipyretic, a non-steroidal anti-inflammatory drug, a cyclooxygenase 3 inhibitor, a xenobiotic, an environmental contaminant, a human blood serum metabolite, a hepatotoxic agent, a ferroptosis inducer and a geroprotector. It is a member of phenols and a member of acetamides. It is functionally related to a 4-aminophenol. |
| Classification | Small molecule |
| Drug class | Analgesics and antipyretics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)Nc1ccc(O)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 103-90-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL112 |
| ChEBI ID | 46195 |
| PubChem CID | 1983 |
| DrugBank | DB00316 |
| UNII ID | 362O9ITL9D (ChemIDplus, GSRS) |
Target
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Financial
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Acetaminophen
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Acetaminophen
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Butalbital
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Acetaminophen
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Phenylephrine
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Chlorpheniramine
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Acetaminophen
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Codeine
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Acetaminophen
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Dextromethorphan
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Acetaminophen
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Dextromethorphan
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Doxylamine
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Acetaminophen
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Diphenhydramine
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Phenylephrine
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Diphenhydramine
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Acetaminophen
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Hydrocodone
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Acetaminophen
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Oxycodone
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Acetaminophen
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Pentazocine
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Acetaminophen
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Propoxyphene
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Acetaminophen
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Pseudoephedrine
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Acetaminophen
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Tramadol
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Safety
Black-box Warning
Black-box warning for: Acetaminophen and codeine, Acetaminophen and codeine phosphate, Acetaminophen with codeine, Acetaminophen, caffeine, dihydrocodeine bitartrate, Acetaminophen,caffeine and pyrilamine maleate, Allzital butalbital and acetaminophen, Apadaz, Benzhydrocodone and acetaminophen, Butalbita,acetaminophen and caffeine, Butalbital, acetaminophen, and caffeine, Butalbital, acetaminophen, caffeine, Butalbital, acetaminophen, caffeine and codeine phosphate, Butalbital, acetaminophen, caffeine, and codeine phosphate, Combogesic iv, Counteract, Direct rx, Endocet, Fioricet, Fioricet with codeine, Hycet, Hydrocodone bit/apap, Hydrocodone bitartate and acetaminophen, Hydrocodone bitartrate and acetaminophen, Hyrdrocodone apap, Lortab, Nalocet, Norco, Ofirmev (acetaminophen), Oxycodone and acetaminophen, Oxycodone and acetaminophen oxycodone hydrochloride, Oxycodone hydrochloride, Oxycodone hydrochloride and acetaminophen, Percocet, Prolate, Propoxyphene and acetaminophen, Theraflu expressmax daytime nighttime value pack, Tramadol acetaminophen, Tramadol hcl and acetaminophen, Tramadol hydrochloride and acetaminophen, Trezix, Tylenol with codeine, Ultracet, Zamicet
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236,449 adverse events reported
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