ibuprofen indications/contra

Stem definitionDrug idCAS RN
anti-inflammatory agents, ibuprofen derivatives 1407 15687-27-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ibuprofen lysine
  • ibuprofen lysinate
  • ibuprofen lysine salt
  • soluphene
  • solufenum
  • neoprofen
  • ibuprofen
  • ibuprofen sodium
A nonsteroidal anti-inflammatory agent with analgesic properties used in the therapy of rheumatism and arthritis.
  • Molecular weight: 206.29
  • Formula: C13H18O2
  • CLOGP: 3.68
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 37.30
  • ALOGS: -3.48
  • ROTB: 4

Drug dosage:

DoseUnitRoute
30 mg P
1.20 g O
1.20 g P
1.20 g R

Approvals:

DateAgencyCompanyOrphan
Sept. 19, 1974 FDA

FDA Adverse Event Reporting System

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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
Drug hypersensitivity 3819.79 27.88 1311 16352 34369 3333827
Completed suicide 3577.44 27.88 1207 16456 29907 3338289
Acute kidney injury 3551.39 27.88 1354 16309 48329 3319867
Overdose 2687.86 27.88 1000 16663 32978 3335218
Toxicity to various agents 2640.92 27.88 1079 16584 45975 3322221
Intentional overdose 2465.03 27.88 768 16895 14457 3353739
Suicide attempt 1583.03 27.88 556 17107 15291 3352905
Gastrointestinal haemorrhage 1533.35 27.88 609 17054 23765 3344431
Angioedema 1526.84 27.88 535 17128 14600 3353596
Vomiting 1351.71 27.88 845 16818 88686 3279510
Haematemesis 1305.16 27.88 393 17270 6492 3361704
Urticaria 974.77 27.88 465 17198 28262 3339934
Melaena 938.04 27.88 310 17353 7002 3361194
Gastric ulcer 931.53 27.88 279 17384 4506 3363690
Metabolic acidosis 905.57 27.88 316 17347 8462 3359734
Tubulointerstitial nephritis 867.85 27.88 259 17404 4127 3364069
Drug interaction 795.05 27.88 478 17185 46334 3321862
Hypotension 772.82 27.88 479 17184 49035 3319161
Gastritis 713.71 27.88 246 17417 6331 3361865
Nausea 684.48 27.88 657 17006 128988 3239208
Upper gastrointestinal haemorrhage 630.75 27.88 199 17464 3844 3364352
Aspirin-exacerbated respiratory disease 608.83 27.88 111 17552 108 3368088
Toxic epidermal necrolysis 607.85 27.88 199 17464 4346 3363850
Anaphylactic reaction 582.26 27.88 256 17407 12798 3355398
Gastric haemorrhage 571.92 27.88 177 17486 3199 3364997
Coma 565.79 27.88 248 17415 12304 3355892
Somnolence 556.56 27.88 333 17330 31871 3336325
Renal failure 554.77 27.88 335 17328 32605 3335591
Abdominal pain upper 546.46 27.88 301 17362 24615 3343581
Hypothermia 542.25 27.88 168 17495 3047 3365149

Pharmacologic Action:

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SourceCodeDescription
ATC C01EB16 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
OTHER CARDIAC PREPARATIONS
Other cardiac preparations
ATC G02CC01 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
OTHER GYNECOLOGICALS
Antiinflammatory products for vaginal administration
ATC M01AE01 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M02AA13 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
ATC R02AX02 RESPIRATORY SYSTEM
THROAT PREPARATIONS
THROAT PREPARATIONS
Other throat preparations
ATC M01AE51 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC N02AJ08 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ19 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
FDA Chemical/Ingredient N0000175721 Nonsteroidal Anti-inflammatory Compounds
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Pain indication 22253000
Rheumatoid arthritis indication 69896004 DOID:7148
Severe pain indication 76948002
Patent ductus arteriosus indication 83330001 DOID:13832
Headache disorder indication 230461009
Dysmenorrhea indication 266599000
Influenza-like symptoms indication 315642008
Fever indication 386661006
Osteoarthritis indication 396275006 DOID:381
Juvenile rheumatoid arthritis indication 410795001
Acute postoperative pain indication 107401000119105
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005 DOID:8677
Ocular hypertension contraindication 4210003 DOID:9282
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Constipation contraindication 14760008 DOID:2089
Mood swings contraindication 18963009
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Body fluid retention contraindication 43498006
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Gastrointestinal perforation contraindication 51875005
Gastrectomy contraindication 53442002
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Leber's optic atrophy contraindication 58610003 DOID:705
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Agoraphobia contraindication 70691001 DOID:593
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Atrophic gastritis contraindication 84568007 DOID:8929
Pulmonary emphysema contraindication 87433001
Kidney disease contraindication 90708001 DOID:2527
Acute abdominal pain contraindication 116290004
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
Seizure disorder contraindication 128613002 DOID:1826
Liver function tests abnormal contraindication 166603001
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007 DOID:6713
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Benign prostatic hyperplasia contraindication 266569009 DOID:2883
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Thromboembolic disorder contraindication 371039008
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000 DOID:13774
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Dysfunction of sphincter of Oddi contraindication 430887001
Hypertensive urgency contraindication 443482000
Smokes tobacco daily contraindication 449868002
Significant Bleeding contraindication
Acute Thromboembolic Stroke contraindication

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.37 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) NEOPROFEN RECORDATI RARE N021903 April 13, 2006 RX INJECTABLE INTRAVENOUS 6342530 Nov. 14, 2020 CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) NEOPROFEN RECORDATI RARE N021903 April 13, 2006 RX INJECTABLE INTRAVENOUS 6342530 Nov. 14, 2020 TREATMENT OF PATENT DUCTUS ARTERIOSUS
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) NEOPROFEN RECORDATI RARE N021903 April 13, 2006 RX INJECTABLE INTRAVENOUS 6344479 March 20, 2021 CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
400MG/4ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 DISCN SOLUTION INTRAVENOUS 6727286 Nov. 27, 2021 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 6727286 Nov. 27, 2021 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
EQ 200MG FREE ACID AND POTASSIUM SALT ADVIL PM PFIZER N021393 Dec. 21, 2005 OTC CAPSULE ORAL 8883849 Jan. 17, 2022 A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE COMPRISING ADMINISTERING A LIQUID COMPOSITION FORMULATED INSIDE A SOFT GEL CAPSULE, AS CLAIMED, TO THE PATIENT
800MG DUEXIS HORIZON PHARMA N022519 April 23, 2011 RX TABLET ORAL 8067451 July 18, 2026 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
800MG DUEXIS HORIZON PHARMA N022519 April 23, 2011 RX TABLET ORAL 8501228 July 18, 2026 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 8735452 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 8871810 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADNUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9114068 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER WITH INTRAVENOUS IBUPROFEN SUCH THAT MEAN ARTERIAL BLOOD PRESSURE DOES NOT INCREASE THE DOSAGE INTERVAL
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9138404 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9295639 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9649284 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9012508 Sept. 14, 2030 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS Nov. 20, 2018 DOSING RECOMMENDATIONS AS NECESSARY FOR FEVER AND PAIN FOR AGES 6MO TO LESS THAN 12 YEARS AND 12 TO 17 YEARS.
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS Nov. 20, 2018 NEW PATIENT POPULATION

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 5.14 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 5.12 WOMBAT-PK CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 4.48 CHEMBL
Cytochrome P450 2C9 Enzyme Ki 4.30 WOMBAT-PK
Arachidonate 5-lipoxygenase Enzyme WOMBAT-PK
Sodium-coupled monocarboxylate transporter 1 Transporter INHIBITOR IC50 4.20 IUPHAR
Interleukin-8 Cytokine IC50 7.30 CHEMBL
Acid-sensing ion channel 1 Ion channel BLOCKER IC50 3.53 SCIENTIFIC LITERATURE
Aldo-keto reductase family 1 member C2 Enzyme IC50 4.37 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 5.96 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 6.07 CHEMBL
Serum albumin Secreted IC50 5.52 CHEMBL
Fatty acid-binding protein, liver Unclassified Ki 4.32 CHEMBL
Dehydrogenase/reductase SDR family member 9 Unclassified IC50 4 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 5.54 CHEMBL
Cyclooxygenase Enzyme IC50 5.70 CHEMBL
Prostaglandin G/H synthase 2 Enzyme Ki 5.05 CHEMBL
Solute carrier family 22 member 20 Transporter Ki 5.96 CHEMBL
Solute carrier family 22 member 6 Transporter Ki 5.33 CHEMBL
Prostaglandin G/H synthase 1 Enzyme Ki 5.05 CHEMBL
Prostaglandin-H2 D-isomerase Enzyme IC50 4.89 CHEMBL

External reference:

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IDSource
2713 IUPHAR_LIGAND_ID
4032936 VUID
N0000189536 NUI
C0074814 UMLSCUI
D00126 KEGG_DRUG
CHEMBL521 ChEMBL_ID
DB01050 DRUGBANK_ID
3672 PUBCHEM_CID
2133 MMSL
5640 RXNORM
38268001 SNOMEDCT_US
387207008 SNOMEDCT_US
4862 MMSL
d00015 MMSL
7027 MMSL
4017840 VANDF
N0000006993 NDFRT
N0000146197 NDFRT
002377 NDDF
CHEMBL175 ChEMBL_ID
CHEMBL427526 ChEMBL_ID
CHEBI:132922 CHEBI
CHEMBL1201141 ChEMBL_ID
CHEMBL1241153 ChEMBL_ID
C016106 MESH_SUPPLEMENTAL_RECORD_UI
D007052 MESH_DESCRIPTOR_UI
N01ORX9D6S UNII
57469-77-9 SECONDARY_CAS_RN
2118 INN_ID
IBP PDB_CHEM_ID
IZP PDB_CHEM_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Good Sense Infants Ibuprofen HUMAN OTC DRUG LABEL 1 0113-0040 SUSPENSION/ DROPS 50 mg ORAL ANDA 9 sections
good sense ibuprofen pm HUMAN OTC DRUG LABEL 2 0113-0050 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0057 SUSPENSION 50 mg ORAL ANDA 9 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0074 TABLET, COATED 200 mg ORAL ANDA 9 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0166 SUSPENSION 100 mg ORAL ANDA 9 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0298 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 9 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0461 TABLET, CHEWABLE 100 mg ORAL ANDA 9 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0517 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0604 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0647 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
Good Sense Ibuprofen HUMAN OTC DRUG LABEL 1 0113-0660 SUSPENSION 100 mg ORAL ANDA 9 sections
Good Sense Ibuprofen HUMAN OTC DRUG LABEL 1 0113-0685 SUSPENSION 100 mg ORAL ANDA 9 sections
Basic Care ibuprofen HUMAN OTC DRUG LABEL 1 0113-0788 TABLET, CHEWABLE 100 mg ORAL ANDA 9 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0897 SUSPENSION 100 mg ORAL ANDA 9 sections
good sense childrens ibuprofen oral suspension HUMAN OTC DRUG LABEL 1 0113-0911 SUSPENSION 100 mg ORAL ANDA 9 sections
basic care ibuprofen HUMAN OTC DRUG LABEL 1 0113-7131 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 9 sections
Basic Care Ibuprofen HUMAN OTC DRUG LABEL 1 0113-7604 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
Basic Care childrens ibuprofen HUMAN OTC DRUG LABEL 1 0113-7897 SUSPENSION 100 mg ORAL ANDA 9 sections
IBUPROFEN HUMAN PRESCRIPTION DRUG LABEL 1 0121-1548 SUSPENSION 100 mg ORAL ANDA 14 sections
Childrens Ibuprofen HUMAN OTC DRUG LABEL 1 0121-1836 SUSPENSION 100 mg ORAL ANDA 10 sections
IBUPROFEN HUMAN PRESCRIPTION DRUG LABEL 1 0121-4774 SUSPENSION 100 mg ORAL ANDA 14 sections
Ibuprofen HUMAN PRESCRIPTION DRUG LABEL 1 0179-0040 TABLET, FILM COATED 800 mg ORAL ANDA 14 sections
IBU HUMAN PRESCRIPTION DRUG LABEL 1 0179-0115 TABLET 600 mg ORAL ANDA 12 sections
IBU HUMAN PRESCRIPTION DRUG LABEL 1 0179-0119 TABLET 800 mg ORAL ANDA 12 sections
Oxycodone hydrochloride and Ibuprofen HUMAN PRESCRIPTION DRUG LABEL 2 0228-4029 TABLET, FILM COATED 400 mg ORAL ANDA 16 sections
IBUPROFEN HUMAN OTC DRUG LABEL 1 0363-0003 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
Ibuprofen HUMAN OTC DRUG LABEL 1 0363-0040 SUSPENSION 100 mg ORAL ANDA 15 sections
Ibuprofen PM HUMAN OTC DRUG LABEL 2 0363-0050 TABLET, FILM COATED 200 mg ORAL ANDA 9 sections
Ibuprofen HUMAN OTC DRUG LABEL 1 0363-0057 SUSPENSION 50 mg ORAL ANDA 9 sections
walprofen congestion relief and pain HUMAN OTC DRUG LABEL 2 0363-0158 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections