paracetamol Indications/Contra | FAERs | Orange Book | BioActivity |

Stem definitionDrug idCAS RN
52 103-90-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • acetaminophen
  • acetaminofen
  • aminofen
  • panadol
  • paracetamol
  • neopap
Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • Molecular weight: 151.17
  • Formula: C8H9NO2
  • CLOGP: 0.49
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 49.33
  • ALOGS: -1.56
  • ROTB: 1

Drug dosage:

DoseUnitRoute
3 g O
3 g P
3 g R

Approvals:

DateAgencyCompanyOrphan
Nov. 7, 1968 FDA POLYMEDICA

FDA Adverse Event Reporting System

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 18417.75 26.03 4866 27523 26248 3327222
Toxicity to various agents 16078.34 26.03 4788 27601 42266 3311204
Overdose 13183.52 26.03 3829 28560 30149 3323321
Intentional overdose 7181.20 26.03 2011 30378 13214 3340256
Acute hepatic failure 5275.52 26.03 1212 31177 2911 3350559
Drug hypersensitivity 3544.06 26.03 1466 30923 34214 3319256
Suicide attempt 3297.58 26.03 1121 31268 14726 3338744
Intentional product misuse 3223.76 26.03 1044 31345 11657 3341813
Drug abuse 3221.50 26.03 1143 31246 17187 3336283
Cardio-respiratory arrest 2571.61 26.03 926 31463 14514 3338956
Death 2454.67 26.03 1887 30502 150437 3203033
Respiratory arrest 2435.95 26.03 823 31566 10545 3342925
Cardiac arrest 2421.12 26.03 1037 31352 26282 3327188
Accidental overdose 2260.18 26.03 695 31694 6423 3347047
Hepatic failure 2108.72 26.03 727 31662 9925 3343545
Vomiting 2077.30 26.03 1388 31001 88143 3265327
Hepatotoxicity 2047.53 26.03 608 31781 4923 3348547
Liver injury 1947.29 26.03 531 31858 3033 3350437
Metabolic acidosis 1881.16 26.03 636 31753 8142 3345328
Coma 1513.16 26.03 595 31794 11957 3341513
Alanine aminotransferase increased 1488.76 26.03 708 31681 22932 3330538
Hepatic necrosis 1460.03 26.03 365 32024 1382 3352088
Poisoning 1349.92 26.03 434 31955 4678 3348792
Hypotension 1332.85 26.03 845 31544 48669 3304801
Somnolence 1259.82 26.03 700 31689 31504 3321966
Aspartate aminotransferase increased 1251.88 26.03 607 31782 20506 3332964
Drug-induced liver injury 1128.02 26.03 379 32010 4734 3348736
Acute kidney injury 1074.32 26.03 740 31649 48943 3304527
Nausea 1071.13 26.03 1106 31283 128539 3224931
Transaminases increased 1069.02 26.03 392 31997 6432 3347038
Medication error 967.80 26.03 426 31963 11445 3342025
Hepatic encephalopathy 892.35 26.03 287 32102 3090 3350380
Coagulopathy 881.85 26.03 311 32078 4528 3348942
International normalised ratio increased 877.02 26.03 424 31965 14191 3339279
Drug ineffective 853.74 26.03 932 31457 115158 3238312
Product use issue 811.32 26.03 414 31975 15587 3337883
Abdominal pain 784.66 26.03 595 31794 45630 3307840
Hepatitis 782.99 26.03 345 32044 9280 3344190
Toxic epidermal necrolysis 770.93 26.03 277 32112 4268 3349202
Confusional state 736.62 26.03 530 31859 37468 3316002
Hepatocellular injury 730.96 26.03 264 32125 4131 3349339
Liver function test abnormal 683.61 26.03 344 32045 12557 3340913
Drug interaction 680.55 26.03 550 31839 46262 3307208
Tachycardia 672.46 26.03 417 31972 22954 3330516
Renal failure 669.44 26.03 473 31916 32467 3321003
Intentional self-injury 642.17 26.03 251 32138 4934 3348536
Encephalopathy 640.99 26.03 278 32111 7184 3346286
Prothrombin time prolonged 636.61 26.03 217 32172 2833 3350637
Depressed level of consciousness 631.83 26.03 314 32075 11151 3342319
Urticaria 622.13 26.03 429 31960 28298 3325172
Loss of consciousness 611.08 26.03 421 31968 27726 3325744
Exposure during pregnancy 557.94 26.03 395 31994 27168 3326302
Unresponsive to stimuli 555.73 26.03 257 32132 7751 3345719
Respiratory depression 547.79 26.03 206 32183 3628 3349842
Mental status changes 541.62 26.03 272 32117 9875 3343595
Acidosis 531.28 26.03 184 32205 2526 3350944
Brain oedema 516.78 26.03 197 32192 3607 3349863
Stevens-Johnson syndrome 490.74 26.03 224 32165 6548 3346922
Lethargy 488.28 26.03 283 32106 13732 3339738
Drug dependence 486.53 26.03 196 32193 4180 3349290
Agitation 483.11 26.03 318 32071 19388 3334082
Cholestasis 471.89 26.03 203 32186 5134 3348336
Exposure via ingestion 465.36 26.03 144 32245 1349 3352121
Drug abuser 459.20 26.03 165 32224 2538 3350932
Multiple organ dysfunction syndrome 449.65 26.03 271 32118 14139 3339331
Jaundice 447.52 26.03 239 32150 9868 3343602
Hepatic enzyme increased 442.70 26.03 263 32126 13362 3340108
Off label use 438.25 26.03 458 31931 53519 3299951
Liver transplant 431.90 26.03 125 32264 908 3352562
Blood bilirubin increased 427.69 26.03 235 32154 10274 3343196
Pyrexia 413.87 26.03 542 31847 80573 3272897
Drug screen positive 413.36 26.03 140 32249 1788 3351682
Angioedema 407.19 26.03 259 32130 14876 3338594
Seizure 401.96 26.03 383 32006 40017 3313453
Anaphylactic reaction 400.81 26.03 243 32146 12811 3340659
Incorrect dose administered 391.56 26.03 245 32144 13669 3339801
Pain 388.18 26.03 493 31896 71064 3282406
Hepatic function abnormal 386.45 26.03 225 32164 11002 3342468
Poisoning deliberate 383.72 26.03 114 32275 917 3352553
Analgesic drug level increased 379.33 26.03 83 32306 140 3353330
Pruritus 375.72 26.03 395 31994 46438 3307032
Abdominal pain upper 374.64 26.03 299 32090 24617 3328853
Substance abuse 367.41 26.03 114 32275 1078 3352392
Bradycardia 365.31 26.03 251 32138 16418 3337052
Constipation 358.65 26.03 319 32070 30493 3322977
Dyspnoea 334.10 26.03 556 31833 102378 3251092
Dizziness 326.25 26.03 469 31920 76043 3277427
Hypersensitivity 317.01 26.03 285 32104 27615 3325855
Drug administration error 307.87 26.03 159 32230 6117 3347353
Hepatitis acute 304.76 26.03 116 32273 2112 3351358
Pyroglutamate increased 297.24 26.03 55 32334 9 3353461
Blood alkaline phosphatase increased 294.77 26.03 185 32204 10368 3343102
Rhabdomyolysis 294.07 26.03 215 32174 15514 3337956
Gamma-glutamyltransferase increased 293.26 26.03 175 32214 8953 3344517
Hypothermia 293.08 26.03 125 32264 3090 3350380
Pulmonary oedema 291.19 26.03 192 32197 11719 3341751
Headache 289.17 26.03 490 31899 91490 3261980
Heart rate increased 284.45 26.03 204 32185 14282 3339188
Rash 275.62 26.03 416 31973 70405 3283065
Blood pH decreased 262.87 26.03 82 32307 790 3352680
Hypoglycaemia 259.26 26.03 192 32197 14126 3339344
Blood creatinine increased 246.03 26.03 222 32167 21596 3331874
Condition aggravated 244.12 26.03 290 32099 38943 3314527
Fall 231.97 26.03 348 32041 58535 3294935
Drug withdrawal syndrome 229.13 26.03 165 32224 11620 3341850
Pulmonary congestion 227.52 26.03 103 32286 2947 3350523
Hypertension 227.31 26.03 277 32112 38189 3315281
Respiratory failure 227.22 26.03 218 32171 22923 3330547
Thrombocytopenia 224.86 26.03 264 32125 35004 3318466
Drug level increased 222.47 26.03 115 32274 4430 3349040
Pneumonia aspiration 220.16 26.03 133 32256 6955 3346515
Hallucination 219.59 26.03 169 32220 13171 3340299
Shock 215.03 26.03 130 32259 6807 3346663
Accidental death 213.49 26.03 65 32324 573 3352897
Alcohol use 204.26 26.03 76 32313 1295 3352175
Dehydration 203.14 26.03 245 32144 33404 3320066
Acute generalised exanthematous pustulosis 202.58 26.03 85 32304 2014 3351456
Malaise 200.24 26.03 344 32045 64833 3288637
Hepatitis fulminant 198.22 26.03 71 32318 1080 3352390
Hepatic steatosis 197.24 26.03 109 32280 4811 3348659
Suicidal ideation 193.38 26.03 177 32212 17528 3335942
Depression 193.37 26.03 260 32129 39510 3313960
Back pain 191.74 26.03 253 32136 37752 3315718
Blood creatine phosphokinase increased 190.80 26.03 154 32235 12859 3340611
Sinus tachycardia 187.02 26.03 105 32284 4780 3348690
Hypoxia 184.53 26.03 134 32255 9557 3343913
Mydriasis 184.40 26.03 88 32301 2846 3350624
Tachypnoea 182.78 26.03 93 32296 3463 3350007
Product quality issue 181.88 26.03 207 32182 26528 3326942
Hypokalaemia 180.77 26.03 153 32236 13652 3339818
Hyperhidrosis 176.41 26.03 192 32197 23418 3330052
Lactic acidosis 176.24 26.03 118 32271 7382 3346088
Anion gap 175.03 26.03 35 32354 26 3353444
Sepsis 174.96 26.03 223 32166 32150 3321320
Insomnia 174.96 26.03 235 32154 35663 3317807
Oxygen saturation decreased 173.00 26.03 131 32258 9960 3343510
Foetal exposure during pregnancy 170.86 26.03 156 32233 15395 3338075
Arteriosclerosis coronary artery 170.38 26.03 83 32306 2811 3350659
Gastrointestinal haemorrhage 169.66 26.03 191 32198 24183 3329287
Acute respiratory distress syndrome 166.22 26.03 104 32285 5790 3347680
Post procedural complication 165.82 26.03 98 32291 4919 3348551
Alcohol poisoning 165.29 26.03 56 32333 715 3352755
Hepatomegaly 160.24 26.03 81 32308 2974 3350496
Drug reaction with eosinophilia and systemic symptoms 159.08 26.03 113 32276 7782 3345688
Renal impairment 158.70 26.03 161 32228 18100 3335370
Dilatation intrahepatic duct acquired 157.99 26.03 36 32353 80 3353390
Ammonia increased 156.32 26.03 64 32325 1422 3352048
Electrocardiogram QT prolonged 154.54 26.03 126 32263 10669 3342801
Coma scale abnormal 153.37 26.03 59 32330 1106 3352364
Sedation 153.06 26.03 100 32289 6001 3347469
Asthenia 152.00 26.03 307 32082 65358 3288112
Serotonin syndrome 151.19 26.03 95 32294 5328 3348142
Hepatitis cholestatic 150.30 26.03 67 32322 1846 3351624
Abdominal discomfort 148.83 26.03 158 32231 18726 3334744
Respiratory distress 148.46 26.03 111 32278 8277 3345193
Disseminated intravascular coagulation 146.51 26.03 98 32291 6119 3347351
Diarrhoea 146.46 26.03 401 31988 103947 3249523
Brain death 146.42 26.03 53 32336 832 3352638
Inadequate analgesia 145.89 26.03 58 32331 1191 3352279
Liver disorder 145.66 26.03 119 32270 10104 3343366
Accidental exposure to product by child 142.42 26.03 59 32330 1352 3352118
Atrial fibrillation 142.26 26.03 173 32216 23768 3329702
Blood lactic acid increased 142.23 26.03 58 32331 1275 3352195
Haematemesis 142.09 26.03 100 32289 6785 3346685
Extra dose administered 141.15 26.03 58 32331 1301 3352169
Blood bicarbonate decreased 140.40 26.03 50 32339 747 3352723
Pneumonia 140.35 26.03 309 32080 69834 3283636
Feeling abnormal 139.93 26.03 184 32205 27341 3326129
Dyspepsia 139.72 26.03 124 32265 11788 3341682
Circulatory collapse 139.31 26.03 94 32295 5955 3347515
Accidental exposure to product 138.77 26.03 86 32303 4706 3348764
Self-medication 136.98 26.03 55 32334 1160 3352310
Bezoar 136.79 26.03 38 32351 233 3353237
Face oedema 135.03 26.03 87 32302 5097 3348373
Rash maculo-papular 132.32 26.03 90 32299 5777 3347693
Delirium 130.75 26.03 109 32280 9519 3343951
Agranulocytosis 130.65 26.03 86 32303 5226 3348244
Disorientation 130.48 26.03 111 32278 9968 3343502
Dysarthria 128.62 26.03 108 32281 9526 3343944
Aggression 128.55 26.03 116 32273 11269 3342201
Premature baby 126.17 26.03 95 32294 7158 3346312
Haemodialysis 126.00 26.03 79 32310 4413 3349057
Nephropathy toxic 125.35 26.03 69 32320 3020 3350450
Tubulointerstitial nephritis 125.20 26.03 78 32311 4308 3349162
Drug eruption 123.69 26.03 82 32307 5043 3348427
Brain injury 123.49 26.03 55 32334 1512 3351958
Cardiomegaly 123.46 26.03 77 32312 4261 3349209
Sopor 123.01 26.03 73 32316 3691 3349779
Renal tubular necrosis 122.21 26.03 68 32321 3040 3350430
Product use in unapproved indication 121.08 26.03 72 32317 3654 3349816
Maternal exposure during breast feeding 120.72 26.03 51 32338 1229 3352241
Wheezing 120.38 26.03 97 32292 8074 3345396
Anxiety 120.00 26.03 208 32181 39421 3314049
Drug effect decreased 119.75 26.03 114 32275 11855 3341615
Intracranial pressure increased 119.71 26.03 53 32336 1436 3352034
Leukocytosis 118.69 26.03 84 32305 5749 3347721
Oliguria 118.62 26.03 59 32330 2091 3351379
Erythema 118.59 26.03 174 32215 28636 3324834
Respiratory rate increased 117.43 26.03 61 32328 2372 3351098
Urinary retention 116.05 26.03 92 32297 7480 3345990
Tremor 115.88 26.03 170 32219 27974 3325496
Apnoea 115.82 26.03 61 32328 2441 3351029
Miosis 114.11 26.03 57 32332 2039 3351431
Coma hepatic 113.13 26.03 35 32354 327 3353143
Hepatic cirrhosis 112.48 26.03 72 32317 4170 3349300
Electrocardiogram QRS complex prolonged 111.73 26.03 49 32340 1297 3352173
Hyperbilirubinaemia 110.99 26.03 65 32324 3206 3350264
Drug ineffective for unapproved indication 110.91 26.03 66 32323 3354 3350116
Brain herniation 110.19 26.03 45 32344 993 3352477
Chest pain 109.88 26.03 202 32187 40073 3313397
General physical health deterioration 109.86 26.03 141 32248 20448 3333022
Blood pressure decreased 109.41 26.03 116 32273 13720 3339750
Hypoxic-ischaemic encephalopathy 108.99 26.03 50 32339 1475 3351995
Toxicologic test abnormal 108.94 26.03 31 32358 210 3353260
Asphyxia 106.14 26.03 49 32340 1467 3352003
Wrong drug administered 105.68 26.03 58 32331 2523 3350947
Aspiration 104.16 26.03 60 32329 2868 3350602
Accidental poisoning 103.96 26.03 30 32359 215 3353255
Anion gap increased 102.33 26.03 34 32355 407 3353063
Body temperature increased 101.15 26.03 71 32318 4795 3348675
Blood ethanol increased 101.07 26.03 25 32364 89 3353381
Drug dispensing error 100.33 26.03 65 32324 3843 3349627
Maternal drugs affecting foetus 99.97 26.03 64 32325 3707 3349763
Body temperature decreased 99.69 26.03 50 32339 1804 3351666
Decreased appetite 99.50 26.03 197 32192 41293 3312177
Anuria 96.91 26.03 57 32332 2834 3350636
Weight decreased 96.85 26.03 191 32198 39920 3313550
Drug diversion 95.35 26.03 32 32357 396 3353074
Renal papillary necrosis 95.01 26.03 23 32366 73 3353397
Septic shock 94.30 26.03 101 32288 12083 3341387
Incorrect route of drug administration 94.29 26.03 89 32300 9154 3344316
Analgesic drug level above therapeutic 94.05 26.03 20 32369 27 3353443
White blood cell count increased 93.91 26.03 103 32286 12657 3340813
Abnormal behaviour 93.70 26.03 92 32297 9936 3343534
Erythema multiforme 93.22 26.03 58 32331 3195 3350275
Cyanosis 92.74 26.03 68 32321 4918 3348552
Fatigue 91.77 26.03 348 32041 106892 3246578
Periorbital oedema 91.74 26.03 44 32345 1438 3352032
Maternal exposure during pregnancy 90.00 26.03 91 32298 10180 3343290
Pupil fixed 89.02 26.03 35 32354 697 3352773
Gastrointestinal sounds abnormal 88.67 26.03 36 32353 782 3352688
Blood sodium decreased 88.29 26.03 65 32324 4731 3348739
Blood pressure increased 88.21 26.03 132 32257 22098 3331372
Blood glucose increased 88.09 26.03 122 32267 19033 3334437
Syncope 87.49 26.03 142 32247 25491 3327979
Pallor 87.28 26.03 70 32319 5785 3347685
Hepatic congestion 86.38 26.03 32 32357 538 3352932
Generalised tonic-clonic seizure 85.04 26.03 79 32310 7963 3345507
Muscle spasticity 84.05 26.03 51 32338 2685 3350785
Activated partial thromboplastin time prolonged 81.65 26.03 48 32341 2384 3351086
Abdominal tenderness 81.62 26.03 40 32349 1372 3352098
Drug use disorder 81.36 26.03 35 32354 883 3352587
Hyperthermia 81.28 26.03 48 32341 2404 3351066
Asthma 80.85 26.03 94 32295 12308 3341162
PCO2 decreased 80.18 26.03 29 32360 454 3353016
Blood urea increased 79.42 26.03 74 32315 7486 3345984
Gastrointestinal disorder 78.96 26.03 86 32303 10483 3342987
Blood potassium decreased 78.43 26.03 68 32321 6262 3347208
Type I hypersensitivity 77.61 26.03 29 32360 500 3352970
Hepatorenal failure 77.50 26.03 24 32365 225 3353245
Migraine 77.46 26.03 83 32306 9933 3343537
Abdominal distension 77.20 26.03 96 32293 13480 3339990
Pancreatitis acute 76.99 26.03 69 32320 6639 3346831
Cough 76.68 26.03 173 32216 39685 3313785
Contusion 75.70 26.03 100 32289 14910 3338560
Therapeutic product cross-reactivity 74.81 26.03 24 32365 255 3353215
Drug level above therapeutic 74.17 26.03 32 32357 813 3352657
Chills 73.79 26.03 121 32268 21901 3331569
Chromaturia 72.89 26.03 57 32332 4541 3348929
Hyponatraemia 72.80 26.03 109 32280 18250 3335220
PO2 increased 72.77 26.03 23 32366 232 3353238
Inflammation 72.41 26.03 70 32319 7415 3346055
Porphyria acute 72.22 26.03 20 32369 121 3353349
Urine output decreased 72.04 26.03 45 32344 2496 3350974
Anaphylactic shock 71.81 26.03 62 32327 5677 3347793
Hyperkalaemia 70.95 26.03 84 32305 11210 3342260
Nasal necrosis 70.70 26.03 16 32373 34 3353436
Premature labour 70.00 26.03 41 32348 2022 3351448
Haemodynamic instability 69.18 26.03 40 32349 1925 3351545
Therapy non-responder 68.91 26.03 81 32308 10728 3342742
Memory impairment 68.46 26.03 95 32294 14843 3338627
Prothrombin level increased 68.28 26.03 20 32369 152 3353318
Upper gastrointestinal haemorrhage 68.19 26.03 52 32337 3991 3349479
Mixed liver injury 68.17 26.03 24 32365 346 3353124
Arrhythmia 68.10 26.03 79 32310 10318 3343152
Pain in extremity 67.72 26.03 188 32201 49024 3304446
Balance disorder 67.61 26.03 86 32303 12353 3341117
Bronchospasm 67.57 26.03 53 32336 4241 3349229
Respiratory disorder 67.53 26.03 61 32328 5929 3347541
Pulseless electrical activity 67.38 26.03 37 32352 1611 3351859
Gait disturbance 67.18 26.03 133 32256 27859 3325611
Haemoglobin decreased 65.67 26.03 138 32251 30156 3323314
Arthralgia 65.34 26.03 213 32176 60648 3292822
Pancytopenia 65.21 26.03 105 32284 18715 3334755
Muscle rigidity 64.76 26.03 45 32344 2989 3350481
Depressed mood 64.04 26.03 62 32327 6579 3346891
Conjunctival hyperaemia 63.72 26.03 30 32359 940 3352530
Sudden death 63.68 26.03 52 32337 4408 3349062
Mental disorder 63.66 26.03 59 32330 5928 3347542
Muscle spasms 63.56 26.03 127 32262 26776 3326694
Rash generalised 63.52 26.03 74 32315 9708 3343762
Petechiae 63.22 26.03 44 32345 2930 3350540
Foetal death 63.19 26.03 38 32351 1968 3351502
Hepatitis toxic 63.02 26.03 30 32359 964 3352506
Ischaemic hepatitis 62.87 26.03 24 32365 440 3353030
Cardiotoxicity 62.77 26.03 36 32353 1706 3351764
Disturbance in attention 62.08 26.03 67 32322 8081 3345389
Eosinophilia 61.69 26.03 53 32336 4820 3348650
Snoring 61.65 26.03 27 32362 712 3352758
Blood glucose decreased 60.74 26.03 52 32337 4706 3348764
Alcohol abuse 60.25 26.03 26 32363 661 3352809
Withdrawal syndrome 60.16 26.03 50 32339 4344 3349126
Macrophages increased 59.75 26.03 13 32376 21 3353449
Arteriosclerosis 59.41 26.03 43 32346 3047 3350423
Lip oedema 58.84 26.03 29 32360 1007 3352463
Leukopenia 58.58 26.03 91 32298 15732 3337738
Irritability 58.53 26.03 76 32313 11140 3342330
Blood pressure systolic increased 58.08 26.03 43 32346 3156 3350314
Adverse drug reaction 58.07 26.03 69 32320 9242 3344228
Osteoarthritis 57.64 26.03 63 32326 7707 3345763
Swelling face 57.47 26.03 76 32313 11340 3342130
Product substitution issue 57.04 26.03 62 32327 7538 3345932
Alanine aminotransferase abnormal 57.00 26.03 22 32367 416 3353054
Respiratory alkalosis 56.88 26.03 23 32366 494 3352976
Haematoma 55.71 26.03 61 32328 7478 3345992
Toxic skin eruption 55.64 26.03 41 32348 2987 3350483
Lung disorder 55.48 26.03 66 32323 8851 3344619
Blood chloride decreased 55.43 26.03 29 32360 1144 3352326
Dysphagia 55.36 26.03 100 32289 19551 3333919
Cognitive disorder 55.24 26.03 62 32327 7812 3345658
Rash macular 54.96 26.03 47 32342 4247 3349223
Areflexia 54.77 26.03 27 32362 938 3352532
Pleural effusion 54.74 26.03 97 32292 18682 3334788
Nervous system disorder 54.29 26.03 50 32339 4983 3348487
Pancreatitis 54.24 26.03 83 32306 14162 3339308
Blood lactate dehydrogenase increased 54.20 26.03 56 32333 6424 3347046
Heart rate decreased 54.16 26.03 51 32338 5227 3348243
Anaemia 53.73 26.03 185 32204 54148 3299322
Blood albumin decreased 53.52 26.03 40 32349 2978 3350492
Neutropenia 53.48 26.03 135 32254 33251 3320219
Respiratory rate decreased 53.45 26.03 26 32363 877 3352593
Hypertonia 53.30 26.03 34 32355 1956 3351514
Hallucination, visual 53.27 26.03 47 32342 4429 3349041
Carbon monoxide poisoning 53.18 26.03 15 32374 98 3353372
Respiratory acidosis 52.71 26.03 28 32361 1140 3352330
Hypophagia 51.82 26.03 53 32336 6008 3347462
Blister 51.65 26.03 63 32326 8671 3344799
Scar 51.49 26.03 37 32352 2592 3350878
Haemolytic anaemia 51.34 26.03 40 32349 3169 3350301
Chest discomfort 51.31 26.03 90 32299 17195 3336275
Therapeutic response unexpected 51.25 26.03 49 32340 5119 3348351
Haematocrit decreased 50.39 26.03 58 32331 7509 3345961
Amnesia 50.32 26.03 69 32320 10657 3342813
Implant site extravasation 50.24 26.03 19 32370 339 3353131
Blood alcohol increased 50.17 26.03 18 32371 275 3353195
Multiple drug therapy 49.69 26.03 13 32376 61 3353409
Haemorrhage 49.41 26.03 96 32293 19825 3333645
Purpura senile 49.39 26.03 11 32378 21 3353449
Incorrect drug dosage form administered 48.98 26.03 15 32374 135 3353335
Infusion related reaction 48.95 26.03 71 32318 11550 3341920
Lip swelling 48.81 26.03 52 32337 6179 3347291
Euphoric mood 48.68 26.03 30 32359 1624 3351846
Melaena 48.62 26.03 56 32333 7256 3346214
Blood pressure diastolic decreased 47.94 26.03 29 32360 1518 3351952
Restlessness 47.84 26.03 56 32333 7382 3346088
Speech disorder 47.84 26.03 62 32327 9070 3344400
Pruritus generalised 47.79 26.03 50 32339 5819 3347651
Road traffic accident 47.67 26.03 54 32335 6872 3346598
Clonus 47.64 26.03 24 32365 874 3352596
Implant site infection 47.64 26.03 22 32367 659 3352811
Ocular icterus 47.62 26.03 26 32363 1119 3352351
Skin abrasion 47.33 26.03 30 32359 1707 3351763
Scratch 46.99 26.03 25 32364 1021 3352449
Oedema peripheral 46.97 26.03 131 32258 34230 3319240
Oesophageal obstruction 46.79 26.03 15 32374 159 3353311
Loss of personal independence in daily activities 46.72 26.03 47 32342 5223 3348247
Drug intolerance 46.70 26.03 70 32319 11728 3341742
Cell death 46.29 26.03 20 32369 510 3352960
Accident 46.18 26.03 27 32362 1327 3352143
Rash pruritic 46.11 26.03 61 32328 9103 3344367
Venoocclusive liver disease 46.03 26.03 27 32362 1335 3352135
Intestinal ischaemia 45.94 26.03 30 32359 1797 3351673
Methaemoglobinaemia 45.86 26.03 20 32369 522 3352948
Abortion spontaneous 45.58 26.03 66 32323 10719 3342751
Mental impairment 45.55 26.03 40 32349 3745 3349725
Haemolysis 45.26 26.03 31 32358 2011 3351459
Gastritis 44.79 26.03 51 32338 6526 3346944
Anal incontinence 44.75 26.03 33 32356 2407 3351063
Dependence 44.72 26.03 21 32368 654 3352816
Amylase increased 44.63 26.03 32 32357 2234 3351236
Cleft lip and palate 44.63 26.03 18 32371 384 3353086
Metabolic alkalosis 44.58 26.03 19 32370 468 3353002
Prothrombin time abnormal 44.44 26.03 16 32373 247 3353223
Oedema 44.30 26.03 77 32312 14603 3338867
Milk-alkali syndrome 44.05 26.03 14 32375 144 3353326
Tarsal tunnel syndrome 43.87 26.03 11 32378 42 3353428
Incorrect drug administration duration 43.64 26.03 37 32352 3304 3350166
Lymphadenopathy 43.35 26.03 55 32334 7877 3345593
Vanishing bile duct syndrome 43.30 26.03 16 32373 267 3353203
Altered state of consciousness 43.26 26.03 47 32342 5711 3347759
Acute haemorrhagic oedema of infancy 42.82 26.03 9 32380 11 3353459
Inappropriate schedule of drug administration 42.63 26.03 73 32316 13680 3339790
Ataxia 42.54 26.03 40 32349 4092 3349378
Anticholinergic syndrome 42.53 26.03 17 32372 354 3353116
Intentional product use issue 42.34 26.03 29 32360 1881 3351589
Dysuria 42.21 26.03 48 32341 6134 3347336
Neutrophil count increased 42.05 26.03 39 32350 3921 3349549
Dialysis 41.91 26.03 40 32349 4169 3349301
Abnormal clotting factor 41.64 26.03 11 32378 54 3353416
Myalgia 41.61 26.03 120 32269 31955 3321515
Arthritis 41.57 26.03 63 32326 10655 3342815
Gastrointestinal necrosis 41.51 26.03 23 32366 1019 3352451
Lipase increased 41.32 26.03 33 32356 2710 3350760
Caesarean section 41.29 26.03 41 32348 4485 3348985
Reye's syndrome 40.83 26.03 11 32378 59 3353411
Myoclonus 40.76 26.03 38 32351 3845 3349625
Movement disorder 40.62 26.03 37 32352 3634 3349836
Hypertransaminasaemia 40.60 26.03 19 32370 587 3352883
Musculoskeletal stiffness 40.58 26.03 72 32317 13878 3339592
Urinary tract infection 40.44 26.03 117 32272 31211 3322259
Palpitations 40.26 26.03 86 32303 18997 3334473
Rash erythematous 40.06 26.03 53 32336 7909 3345561
Stupor 39.85 26.03 23 32366 1103 3352367
Systemic inflammatory response syndrome 39.77 26.03 25 32364 1402 3352068
Aspirin-exacerbated respiratory disease 39.56 26.03 14 32375 205 3353265
Blood potassium increased 39.51 26.03 38 32351 3998 3349472
Myocardial fibrosis 39.32 26.03 14 32375 209 3353261
Rectal haemorrhage 39.16 26.03 57 32332 9301 3344169
Ventricular tachycardia 39.15 26.03 45 32344 5817 3347653
Ascites 39.07 26.03 57 32332 9320 3344150
Hypoventilation 38.58 26.03 22 32367 1031 3352439
Dry mouth 38.48 26.03 58 32331 9764 3343706
Nightmare 38.46 26.03 44 32345 5658 3347812
Conjunctivitis 38.44 26.03 32 32357 2786 3350684
Spleen congestion 38.42 26.03 12 32377 116 3353354
Hyperventilation 38.26 26.03 25 32364 1499 3351971
Bilirubin conjugated increased 38.14 26.03 21 32368 919 3352551
Environmental exposure 37.98 26.03 11 32378 80 3353390
Incoherent 37.90 26.03 25 32364 1523 3351947
Use of accessory respiratory muscles 37.79 26.03 12 32377 123 3353347
Troponin increased 37.77 26.03 27 32362 1876 3351594
Haemophilus infection 37.70 26.03 14 32375 237 3353233
Continuous haemodiafiltration 37.39 26.03 18 32371 593 3352877
Acute respiratory failure 37.39 26.03 39 32350 4523 3348947
Gun shot wound 37.25 26.03 16 32373 402 3353068
Dermatitis exfoliative 37.11 26.03 31 32358 2712 3350758
Ileus paralytic 37.04 26.03 25 32364 1583 3351887
Lymphocyte stimulation test positive 37.00 26.03 17 32372 503 3352967
Atelectasis 36.91 26.03 34 32355 3388 3350082
Dermatitis bullous 36.84 26.03 28 32361 2138 3351332
Treatment noncompliance 36.73 26.03 54 32335 8891 3344579
Urinary incontinence 36.58 26.03 44 32345 5968 3347502
Neuralgia 36.54 26.03 33 32356 3206 3350264
Obstructive airways disorder 36.47 26.03 25 32364 1624 3351846
Electrolyte imbalance 36.42 26.03 31 32358 2783 3350687
Blood calcium decreased 36.36 26.03 31 32358 2789 3350681
Cholelithiasis 36.30 26.03 51 32338 8057 3345413
Blood pressure systolic decreased 36.25 26.03 22 32367 1158 3352312
Flushing 36.21 26.03 69 32320 14044 3339426
Bundle branch block right 36.15 26.03 26 32363 1824 3351646
Alcoholism 36.10 26.03 19 32370 759 3352711
Major depression 35.65 26.03 24 32365 1513 3351957
Streptococcal infection 35.59 26.03 22 32367 1197 3352273
Rhinitis 35.31 26.03 23 32366 1372 3352098
Head injury 35.12 26.03 42 32347 5661 3347809
Swollen tongue 35.12 26.03 46 32343 6797 3346673
Visual impairment 34.87 26.03 68 32321 14078 3339392
Gastrooesophageal reflux disease 34.85 26.03 61 32328 11630 3341840
Neutrophilia 34.83 26.03 18 32371 692 3352778
Cholestatic liver injury 34.73 26.03 15 32374 382 3353088
Rash papular 34.50 26.03 33 32356 3449 3350021
Rash pustular 34.49 26.03 27 32362 2153 3351317
Hyperaesthesia 34.49 26.03 24 32365 1597 3351873
Tinnitus 34.47 26.03 47 32342 7218 3346252
Muscular weakness 34.40 26.03 84 32305 20257 3333213
Laceration 34.32 26.03 35 32354 3953 3349517
Vision blurred 34.31 26.03 82 32307 19507 3333963
Malnutrition 34.19 26.03 30 32359 2806 3350664
Posturing 34.17 26.03 13 32376 236 3353234
Hyperammonaemia 34.04 26.03 24 32365 1631 3351839
Cold sweat 33.80 26.03 31 32358 3072 3350398
Ventricular fibrillation 33.65 26.03 36 32353 4297 3349173
Hallucination, auditory 33.25 26.03 33 32356 3608 3349862
Hyperlactacidaemia 33.24 26.03 16 32373 527 3352943
Blood phosphorus decreased 33.09 26.03 19 32370 902 3352568
Hypoaesthesia 33.01 26.03 94 32295 24845 3328625
Wound dehiscence 33.00 26.03 21 32368 1203 3352267
Blood creatine increased 32.89 26.03 21 32368 1210 3352260
Anaphylactoid reaction 32.86 26.03 22 32367 1374 3352096
Jaundice neonatal 32.68 26.03 15 32374 443 3353027
Pharyngeal oedema 32.62 26.03 36 32353 4451 3349019
Swelling 32.58 26.03 79 32310 18965 3334505
Hypercreatininaemia 32.49 26.03 11 32378 140 3353330
Blood pH increased 32.47 26.03 13 32376 272 3353198
Rheumatoid arthritis 32.44 26.03 70 32319 15568 3337902
Unevaluable event 32.40 26.03 63 32326 13013 3340457
Faecaloma 32.32 26.03 21 32368 1247 3352223
PO2 decreased 32.29 26.03 16 32373 562 3352908
International normalised ratio abnormal 32.23 26.03 21 32368 1253 3352217
Oropharyngeal swelling 32.08 26.03 14 32375 366 3353104
Anoxia 32.07 26.03 11 32378 146 3353324
Generalised oedema 32.06 26.03 32 32357 3523 3349947
Thermal burn 31.89 26.03 20 32369 1117 3352353
Hepatorenal syndrome 31.71 26.03 17 32372 705 3352765
Wrong technique in product usage process 31.39 26.03 72 32317 16679 3336791
Purpura 31.30 26.03 29 32360 2911 3350559
Haematuria 31.07 26.03 53 32336 9899 3343571
Liver function test increased 31.00 26.03 24 32365 1883 3351587
Renal disorder 30.88 26.03 44 32345 7040 3346430
Pseudomonas infection 30.85 26.03 24 32365 1897 3351573
Decerebrate posture 30.67 26.03 8 32381 37 3353433
Nystagmus 30.56 26.03 24 32365 1923 3351547
Ventricular arrhythmia 30.31 26.03 19 32370 1060 3352410
Neurological decompensation 30.28 26.03 16 32373 644 3352826
Drug effect incomplete 30.24 26.03 46 32343 7804 3345666
Purulent discharge 30.24 26.03 20 32369 1224 3352246
Teratogenicity 30.11 26.03 9 32380 74 3353396
Coagulation factor V level decreased 30.07 26.03 10 32379 120 3353350
Hypotonia 29.95 26.03 28 32361 2843 3350627
Lower respiratory tract infection 29.93 26.03 42 32347 6627 3346843
Burning sensation 29.91 26.03 49 32340 8855 3344615
Paranoia 29.86 26.03 32 32357 3827 3349643
Suicidal behaviour 29.82 26.03 17 32372 796 3352674
Deafness neurosensory 29.72 26.03 18 32371 944 3352526
Vertigo positional 29.57 26.03 14 32375 444 3353026
Drug withdrawal syndrome neonatal 29.55 26.03 25 32364 2225 3351245
Stridor 29.23 26.03 18 32371 973 3352497
Sinusitis 29.16 26.03 70 32319 16698 3336772
Hypovolaemic shock 29.12 26.03 20 32369 1303 3352167
Gastric ulcer 29.08 26.03 35 32354 4750 3348720
Stress 29.03 26.03 44 32345 7442 3346028
Blood urea abnormal 28.90 26.03 11 32378 200 3353270
Onychomycosis 28.83 26.03 16 32373 711 3352759
Metabolic encephalopathy 28.79 26.03 17 32372 851 3352619
Blood culture positive 28.76 26.03 20 32369 1330 3352140
Failure of child resistant mechanism for pharmaceutical product 28.73 26.03 7 32382 23 3353447
Electroencephalogram abnormal 28.42 26.03 20 32369 1355 3352115
Sleep disorder 28.26 26.03 46 32343 8267 3345203
Rash morbilliform 28.25 26.03 16 32373 740 3352730
Pharyngitis 28.20 26.03 26 32363 2594 3350876
Aphthous ulcer 28.18 26.03 21 32368 1556 3351914
Aortic arteriosclerosis 28.08 26.03 18 32371 1044 3352426
Cardiac failure 27.81 26.03 77 32312 20028 3333442
Peripheral swelling 27.68 26.03 67 32322 16065 3337405
Hypernatraemia 27.65 26.03 21 32368 1601 3351869
Nervousness 27.64 26.03 39 32350 6185 3347285
Protein total decreased 27.19 26.03 19 32370 1273 3352197
Transcription medication error 27.11 26.03 10 32379 166 3353304
Yellow skin 27.08 26.03 16 32373 802 3352668
Aminoaciduria 26.95 26.03 8 32381 64 3353406
Epistaxis 26.95 26.03 62 32327 14389 3339081
Pancoast's syndrome 26.86 26.03 5 32384 1 3353469
Emergency care examination abnormal 26.86 26.03 5 32384 1 3353469
Ureteric obstruction 26.85 26.03 13 32376 434 3353036
Self-injurious ideation 26.81 26.03 16 32373 817 3352653
Cryptorchism 26.70 26.03 12 32377 337 3353133
Dysstasia 26.68 26.03 30 32359 3786 3349684
Staphylococcus test positive 26.66 26.03 16 32373 825 3352645
Scab 26.53 26.03 20 32369 1508 3351962
Vertigo 26.37 26.03 54 32335 11578 3341892
Cardiogenic shock 26.36 26.03 30 32359 3836 3349634
Lacrimation increased 26.19 26.03 28 32361 3340 3350130
Opiates positive 26.12 26.03 8 32381 72 3353398
Immune thrombocytopenic purpura 26.11 26.03 24 32365 2385 3351085
Post-thoracotomy pain syndrome 26.10 26.03 5 32384 2 3353468
Resorption bone increased 26.04 26.03 11 32378 265 3353205

Pharmacologic Action:

SourceCodeDescription
ATC N02BE01 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Anilides
ATC N02AJ01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ06 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ13 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ17 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02BE51 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Anilides
ATC N02BE71 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Anilides
CHEBI has role CHEBI:35481 non-narcotic analgesic
CHEBI has role CHEBI:35493 antipyretic
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drug
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D058633 Antipyretics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Pain indication 22253000
Toothache indication 27355003
Migraine indication 37796009 DOID:6364
Joint pain indication 57676002
Allergic rhinitis indication 61582004
Common cold indication 82272006 DOID:10459
Backache indication 161891005
Headache disorder indication 230461009
Influenza-like symptoms indication 315642008
Fever indication 386661006
Tension-type headache indication 398057008
Arthritic Pain indication
Pain Treatment Adjunct indication
Vascular headache off-label use 128187005
Fibromyalgia off-label use 203082005 DOID:631
Hepatic encephalopathy contraindication 13920009 DOID:13413
Cirrhosis of liver contraindication 19943007 DOID:5082
Hepatic failure contraindication 59927004
Disease of liver contraindication 235856003 DOID:409

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.69 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
325MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 7976870 June 1, 2027 METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT IP N022450 Nov. 2, 2010 RX SOLUTION IV (INFUSION) 9610265 Nov. 13, 2028 MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS
325MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8372432 March 11, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8668929 March 11, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8377453 Nov. 19, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT IP N022450 Nov. 2, 2010 RX SOLUTION IV (INFUSION) 9399012 Sept. 11, 2031 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANALGESIC AND ANTIPYRETIC ACTIVITY
325MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8741885 May 16, 2032 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9468636 May 16, 2032 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT IP N022450 Nov. 2, 2010 RX SOLUTION IV (INFUSION) Jan. 27, 2020 REVISIONS TO THE PACKAGE INSERT BASED ON DATA FROM A RANDOMIZED, PLACEBO CONTROLLED, MULTICENTER STUDY OF INTRAVENOUS ACETAMINOPHEN FOR THE TREATMENT OF ACUTE PAIN IN PEDIATRIC PATIENTS TO FULFILL THE POST-MARKETING REQUIREMENT 1704-1
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT IP N022450 Nov. 2, 2010 RX SOLUTION IV (INFUSION) July 27, 2020 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Transient receptor potential cation channel subfamily V member 1 Ion channel OPENER WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 4.31 WOMBAT-PK CHEMBL
Cannabinoid receptor 1 GPCR AGONIST WOMBAT-PK SCIENTIFIC LITERATURE
Carbonic anhydrase 3 Enzyme Ki 5.15 CHEMBL
Carbonic anhydrase 2 Enzyme Ki 5.21 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 4.97 CHEMBL
Carbonic anhydrase 7 Enzyme Ki 5.04 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 4.15 CHEMBL
Carbonic anhydrase 12 Enzyme Ki 5.39 CHEMBL
Myoglobin Unclassified IC50 5.64 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 4.94 CHEMBL
Nuclear receptor subfamily 1 group I member 3 Nuclear hormone receptor WOMBAT-PK
Carbonic anhydrase 1 Enzyme Ki 5 CHEMBL
Arachidonate 5-lipoxygenase-activating protein Cytosolic other IC50 4.36 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 4.52 CHEMBL
Carbonic anhydrase 15 Enzyme Ki 5.03 CHEMBL
Arachidonate 15-lipoxygenase Enzyme IC50 4.55 DRUG MATRIX

External reference:

IDSource
CHEBI:46195 CHEBI
DB00316 DRUGBANK_ID
4017513 VUID
N0000145898 NUI
C0000970 UMLSCUI
D00217 KEGG_DRUG
CHEMBL112 ChEMBL_ID
362O9ITL9D UNII
626 INN_ID
5005 MMSL
161 RXNORM
387517004 SNOMEDCT_US
90332006 SNOMEDCT_US
4119 MMSL
d00049 MMSL
4992 MMSL
4017513 VANDF
52845 MMSL
N0000145898 NDFRT
N0000007359 NDFRT
001605 NDDF
D000082 MESH_DESCRIPTOR_UI
1983 PUBCHEM_CID
TYL PDB_CHEM_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Norco HUMAN PRESCRIPTION DRUG LABEL 2 0023-6002 TABLET 325 mg ORAL ANDA 14 sections
Norco HUMAN PRESCRIPTION DRUG LABEL 2 0023-6021 TABLET 325 mg ORAL ANDA 14 sections
Norco HUMAN PRESCRIPTION DRUG LABEL 2 0023-6022 TABLET 325 mg ORAL ANDA 14 sections
Childrens Dimetapp Multi-Symptom Cold and Flu HUMAN OTC DRUG LABEL 3 0031-2249 LIQUID 320 mg ORAL OTC MONOGRAPH FINAL 9 sections
ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU HUMAN OTC DRUG LABEL 3 0031-8721 CAPSULE, LIQUID FILLED 325 mg ORAL OTC MONOGRAPH FINAL 9 sections
ROBITUSSIN PEAK COLD NIGHTTIME COLD PLUS FLU HUMAN OTC DRUG LABEL 3 0031-8722 CAPSULE, LIQUID FILLED 325 mg ORAL OTC MONOGRAPH FINAL 9 sections
ROBITUSSIN PEAK COLD NASAL RELIEF HUMAN OTC DRUG LABEL 2 0031-8731 TABLET 325 mg ORAL OTC monograph final 9 sections
ROBITUSSIN PEAK COLD NIGHTTIME NASAL RELIEF HUMAN OTC DRUG LABEL 3 0031-8732 TABLET 325 mg ORAL OTC monograph final 9 sections
ROBITUSSIN PEAK COLD NIGHTTIME MULTI-SYMPTOM COLD HUMAN OTC DRUG LABEL 3 0031-8735 LIQUID 160 mg ORAL OTC monograph final 9 sections
Robitussin Maximum Strength Severe Cough Plus Sore Throat HUMAN OTC DRUG LABEL 2 0031-8750 LIQUID 650 mg ORAL OTC Monograph Final 9 sections
Robitussin Severe Multi-Symptom Cough Cold Flu HUMAN OTC DRUG LABEL 4 0031-8751 LIQUID 650 mg ORAL OTC monograph final 9 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 650 mg ORAL OTC MONOGRAPH FINAL 9 sections
Oxycodone and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0054-0551 TABLET 325 mg ORAL ANDA 14 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-3686 SOLUTION 325 mg ORAL ANDA 13 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-4650 TABLET 325 mg ORAL ANDA 13 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-8648 SOLUTION 325 mg ORAL ANDA 13 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-8650 TABLET 325 mg ORAL ANDA 13 sections
Excedrin HUMAN OTC DRUG LABEL 3 0067-2000 TABLET, FILM COATED 250 mg ORAL OTC monograph not final 9 sections
Excedrin HUMAN OTC DRUG LABEL 3 0067-2021 TABLET, COATED 250 mg ORAL OTC monograph not final 9 sections
Excedrin HUMAN OTC DRUG LABEL 3 0067-2035 TABLET, COATED 250 mg ORAL NDA 10 sections
EXCEDRIN HUMAN OTC DRUG LABEL 3 0067-2039 TABLET, FILM COATED 250 mg ORAL NDA 9 sections
Excedrin PM Triple Action Caplets HUMAN OTC DRUG LABEL 3 0067-2056 TABLET, COATED 250 mg ORAL OTC monograph not final 9 sections
COMTREX HUMAN OTC DRUG LABEL 3 0067-2077 TABLET, COATED 325 mg ORAL OTC monograph final 16 sections
COMTREX HUMAN OTC DRUG LABEL 5 0067-2083 KIT 325 mg None OTC monograph final 15 sections
COMTREX HUMAN OTC DRUG LABEL 5 0067-2083 KIT 325 mg None OTC monograph final 15 sections
THERAFLU HUMAN OTC DRUG LABEL 3 0067-6426 POWDER, FOR SOLUTION 500 mg ORAL OTC monograph final 9 sections
Theraflu HUMAN OTC DRUG LABEL 3 0067-7916 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 16 sections
Theraflu HUMAN OTC DRUG LABEL 3 0067-7917 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 9 sections
THERAFLU HUMAN OTC DRUG LABEL 3 0067-7918 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 9 sections
Excedrin HUMAN OTC DRUG LABEL 3 0067-8103 TABLET, FILM COATED 250 mg ORAL ANDA 9 sections