phenylephrine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
sympathomimetic, phenethyl derivatives 2146 59-42-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • (-)-Phenylephrine
  • (-)-m-Hydroxy-alpha-(methylaminomethyl)benzyl alcohol
  • (-)-m-Oxedrine
  • (-)-m-Synephrine
  • (R)-Phenylephrine
  • L-Phenylephedrine
  • mesatone
  • metaoxedrin
  • metaoxedrine
  • metasympatol
  • metasynephrine
  • mezaton
  • l-Phenylephrine
  • phenylephrine
  • phenylephrine hydrochloride
  • phenylephrine tannate
  • phenylephrine bitartrate
  • phenylephrine HCl
An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.
  • Molecular weight: 167.21
  • Formula: C9H13NO2
  • CLOGP: -0.09
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 3
  • TPSA: 52.49
  • ALOGS: -0.88
  • ROTB: 3

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
4 mg P
4 mg N
40 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 4.98 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 35 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Jan. 21, 1952 FDA ANI PHARMS

FDA Adverse Event Reporting System (Female)

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
Toxic anterior segment syndrome 256.10 38.79 38 947 255 2356845
Toxicity to various agents 232.55 38.79 82 903 32672 2324428
Completed suicide 173.20 38.79 59 926 20975 2336125
Bradycardia 170.61 38.79 49 936 9932 2347168
Exposure during pregnancy 151.51 38.79 56 929 25163 2331937
Intentional overdose 130.28 38.79 41 944 11280 2345820
Drug ineffective 129.92 38.79 77 908 101547 2255553
Overdose 122.29 38.79 45 940 19862 2337238
Cardiac arrest 115.24 38.79 40 945 14890 2342210
Cardio-respiratory arrest 104.61 38.79 33 952 9113 2347987
Drug abuse 103.59 38.79 35 950 11991 2345109
Maternal exposure during pregnancy 92.60 38.79 34 951 14829 2342271
Hypotension 91.43 38.79 42 943 32394 2324706
Drug hypersensitivity 88.32 38.79 46 939 46597 2310503
Death 83.88 38.79 54 931 81414 2275686
Anterior chamber cell 83.72 38.79 12 973 60 2357040
Corneal epithelium defect 79.31 38.79 12 973 92 2357008
Arteriospasm coronary 74.26 38.79 15 970 670 2356430
Punctate keratitis 73.92 38.79 12 973 151 2356949
Seizure 72.99 38.79 33 952 24433 2332667
Intentional product misuse 71.43 38.79 25 960 9464 2347636
Corneal oedema 71.13 38.79 13 972 339 2356761
Suicide attempt 67.20 38.79 25 960 11257 2345843
Respiratory arrest 61.13 38.79 20 965 6158 2350942
Accidental overdose 56.61 38.79 17 968 3955 2353145
Tachycardia 54.85 38.79 24 961 16385 2340715
Stress cardiomyopathy 52.69 38.79 13 972 1448 2355652
Vomiting 48.86 38.79 37 948 71565 2285535
Ocular hyperaemia 47.78 38.79 15 970 4041 2353059
Ventricular tachycardia 43.38 38.79 13 972 2998 2354102
Depressed level of consciousness 42.13 38.79 16 969 7588 2349512
Reversible cerebral vasoconstriction syndrome 41.59 38.79 8 977 276 2356824
Pulseless electrical activity 41.53 38.79 10 975 1005 2356095
Accidental exposure to product by child 40.97 38.79 9 976 602 2356498
Diabetes insipidus 39.31 38.79 8 977 370 2356730
Live birth 39.14 38.79 10 975 1281 2355819
Pulmonary oedema 39.02 38.79 15 970 7348 2349752

FDA Adverse Event Reporting System (Male)

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 abuse 375.00 49.09 103 707 13586 1732385
Toxicity to various agents 274.78 49.09 97 713 29044 1716927
Intentional product misuse 245.38 49.09 65 745 7293 1738678
Serotonin syndrome 133.49 49.09 33 777 2755 1743216
Overdose 127.62 49.09 48 762 16653 1729318
Completed suicide 121.39 49.09 46 764 16266 1729705
Intentional overdose 121.08 49.09 38 772 7632 1738339
Accidental overdose 88.58 49.09 26 784 4138 1741833
Cardio-respiratory arrest 86.61 49.09 31 779 9262 1736709
Cardiac arrest 80.30 49.09 34 776 15896 1730075
Toxic anterior segment syndrome 75.10 49.09 13 797 178 1745793
Hypertensive emergency 68.29 49.09 12 798 180 1745791
Accidental exposure to product by child 67.91 49.09 15 795 757 1745214
Respiratory arrest 67.89 49.09 23 787 5816 1740155
Mydriasis 64.89 49.09 16 794 1308 1744663
Suicide attempt 58.93 49.09 22 788 7359 1738612
Drug ineffective 57.68 49.09 44 766 63757 1682214
Hangover 54.18 49.09 10 800 200 1745771
Hypertension 49.67 49.09 26 784 19422 1726549
Death 49.44 49.09 46 764 87397 1658574

Pharmacologic Action:

SourceCodeDescription
ATC C01CA06 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
Adrenergic and dopaminergic agents
ATC R01AA04 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Sympathomimetics, plain
ATC R01AB01 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Sympathomimetics, combinations excl. corticosteroids
ATC R01BA03 RESPIRATORY SYSTEM
NASAL PREPARATIONS
NASAL DECONGESTANTS FOR SYSTEMIC USE
Sympathomimetics
ATC S01FB01 SENSORY ORGANS
OPHTHALMOLOGICALS
MYDRIATICS AND CYCLOPLEGICS
Sympathomimetics excl. antiglaucoma preparations
ATC S01GA05 SENSORY ORGANS
OPHTHALMOLOGICALS
DECONGESTANTS AND ANTIALLERGICS
Sympathomimetics used as decongestants
ATC R01BA53 RESPIRATORY SYSTEM
NASAL PREPARATIONS
NASAL DECONGESTANTS FOR SYSTEMIC USE
Sympathomimetics
ATC S01FB51 SENSORY ORGANS
OPHTHALMOLOGICALS
MYDRIATICS AND CYCLOPLEGICS
Sympathomimetics excl. antiglaucoma preparations
ATC S01GA55 SENSORY ORGANS
OPHTHALMOLOGICALS
DECONGESTANTS AND ANTIALLERGICS
Sympathomimetics used as decongestants
MeSH PA D018663 Adrenergic Agents
MeSH PA D000322 Adrenergic Agonists
MeSH PA D058646 Adrenergic alpha-1 Receptor Agonists
MeSH PA D000316 Adrenergic alpha-Agonists
FDA EPC N0000186105 alpha-1 Adrenergic Agonist
FDA MoA N0000009917 Adrenergic alpha1-Agonists
CHEBI has role CHEBI:38147 cardiotonic drug
CHEBI has role CHEBI:50513 mydriatic agent
CHEBI has role CHEBI:50267 protective agent
CHEBI has role CHEBI:50514 vasoconstrictor agent
CHEBI has role CHEBI:35524 sympathomimetic agent
CHEBI has role CHEBI:77715 nasal decongestant
CHEBI has role CHEBI:35569 alpha-adrenergic agonist
MeSH PA D002316 Cardiotonic Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D009184 Mydriatics
MeSH PA D014663 Nasal Decongestants
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D020011 Protective Agents
MeSH PA D019141 Respiratory System Agents
MeSH PA D013566 Sympathomimetics
MeSH PA D014662 Vasoconstrictor Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Proctitis indication 3951002 DOID:3127
Sinus headache indication 4969004
Vasomotor rhinitis indication 8229003 DOID:4730
Dilated pupil indication 37125009
Cough indication 49727002
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Rhinitis indication 70076002 DOID:4483
Hemorrhoids indication 70153002 DOID:9746
Red eye indication 75705005
Sneezing indication 76067001
Rectal pain indication 77880009
Common cold indication 82272006 DOID:10459
Pruritus ani indication 90446007
Headache disorder indication 230461009
Influenza-like symptoms indication 315642008
Seasonal allergic rhinitis indication 367498001
Fever indication 386661006
Allergic conjunctivitis indication 473460002 DOID:11204
Prevention of Posterior Synechiae indication
Priapism off-label use 6273006 DOID:9286
Low blood pressure off-label use 45007003
Metabolic alkalosis contraindication 1388004
Brain damage contraindication 2470005
Anuria contraindication 2472002 DOID:2983
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Goiter contraindication 3716002 DOID:12176
Ocular hypertension contraindication 4210003 DOID:9282
Gastritis contraindication 4556007 DOID:4029
Hypocalcemia contraindication 5291005
Tachyarrhythmia contraindication 6285003
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Urinary tract obstruction contraindication 7163005 DOID:5200
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
Hyperkalemia contraindication 14140009
Severe chronic ulcerative colitis contraindication 14311001
Constipation contraindication 14760008 DOID:2089
Hyperbilirubinemia contraindication 14783006 DOID:2741
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Chronic disease of respiratory system contraindication 17097001
Mood swings contraindication 18963009
Pulmonary edema contraindication 19242006 DOID:11396
Lowered convulsive threshold contraindication 19260006
Hashimoto thyroiditis contraindication 21983002
Myocardial infarction contraindication 22298006 DOID:5844
Disorder of the central nervous system contraindication 23853001 DOID:331
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Ventricular tachycardia contraindication 25569003
Acute tuberculosis contraindication 25629007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Toxic megacolon contraindication 28536002 DOID:1770
Atony of colon contraindication 29479008
Hypercapnia contraindication 29596007
Bronchitis contraindication 32398004 DOID:6132
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Hypernatremia contraindication 39355002
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Body fluid retention contraindication 43498006
Conduction disorder of the heart contraindication 44808001
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Anxiety contraindication 48694002
Bradycardia contraindication 48867003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Acidosis contraindication 51387008
Vitamin K deficiency contraindication 52675005 DOID:11249
Nasal polyp contraindication 52756005
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Paralytic ileus contraindication 55525008 DOID:8442
Heart disease contraindication 56265001 DOID:114
Peptic reflux disease contraindication 57643001
Acute nephropathy contraindication 58574008
Metabolic acidosis contraindication 59455009
Hepatic failure contraindication 59927004
Perforation of tympanic membrane contraindication 60442001
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Arterial thrombosis contraindication 65198009
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Psychotic disorder contraindication 69322001
Poisoning by acetaminophen contraindication 70273001
Agoraphobia contraindication 70691001 DOID:593
Arteriosclerotic vascular disease contraindication 72092001
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Factor II deficiency contraindication 73975000
Reye's syndrome contraindication 74351001 DOID:14525
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Spastic paralysis contraindication 78403003
Disturbance of salivary secretion contraindication 78948009
Decreased respiratory function contraindication 80954004
Disorder of brain contraindication 81308009 DOID:936
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Oliguria contraindication 83128009
Cor pulmonale contraindication 83291003 DOID:8515
Hiatal hernia contraindication 84089009 DOID:12642
Epilepsy contraindication 84757009 DOID:1826
Pulmonary emphysema contraindication 87433001
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Thyrotoxicosis contraindication 90739004 DOID:7997
Hemophilia contraindication 90935002
Myasthenia gravis contraindication 91637004 DOID:437
Dermatitis herpetiformis contraindication 111196000 DOID:8505
Anemia due to enzyme deficiency contraindication 111577008
Acute abdominal pain contraindication 116290004
Procedure on urinary system contraindication 118677009
Deficiency of glucose-6-phosphate dehydrogenase contraindication 124134002 DOID:2862
Open wound contraindication 125643001
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
von Willebrand disorder contraindication 128105004 DOID:12531
Seizure disorder contraindication 128613002
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Insomnia contraindication 193462001
Partial atrioventricular block contraindication 195039008
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Myocardial dysfunction contraindication 233928007
Arterial aneurysm contraindication 233981004
Gastroesophageal reflux disease contraindication 235595009 DOID:8534
Disease of liver contraindication 235856003 DOID:409
Hyporeninemic hypoaldosteronism contraindication 236464008
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Hypocomplementemic urticarial vasculitis contraindication 239945009
Rhabdomyolysis contraindication 240131006
Pyloric obstruction contraindication 244815007
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Drowsy contraindication 271782001
Peripheral edema contraindication 271809000
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Familial hyperkalemic periodic paralysis contraindication 304737009 DOID:14451
Bone marrow depression contraindication 307762000
Infective otitis media contraindication 312218008
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Pseudomembranous enterocolitis contraindication 397683000
Gastric ulcer contraindication 397825006 DOID:10808
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Traumatic injury contraindication 417746004
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Porphyria contraindication 418470004
Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant contraindication 422681000
Dysfunction of sphincter of Oddi contraindication 430887001
Hypertensive urgency contraindication 443482000
Acute erosive gastritis contraindication 444926003
Azotemia contraindication 445009001
Severe dehydration contraindication 450316000
Acute exacerbation of asthma contraindication 708038006
Predisposition to Glaucoma contraindication
Nervousness contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.15 acidic
pKa2 13.64 acidic
pKa3 8.71 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 1% BASE OMIDRIA OMEROS N205388 May 30, 2014 RX SOLUTION IRRIGATION 8173707 July 30, 2023 MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING POSTOPERATIVE OCULAR PAIN
EQ 1% BASE OMIDRIA OMEROS N205388 May 30, 2014 RX SOLUTION IRRIGATION 9278101 July 30, 2023 MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING POSTOPERATIVE OCULAR PAIN
10% PHENYLEPHRINE HYDROCHLORIDE PARAGON BIOTECK N203510 March 21, 2013 RX SOLUTION/DROPS OPHTHALMIC 8859623 Nov. 14, 2033 DILATION OF THE PUPIL
2.5% PHENYLEPHRINE HYDROCHLORIDE PARAGON BIOTECK N203510 March 21, 2013 RX SOLUTION/DROPS OPHTHALMIC 8859623 Nov. 14, 2033 DILATION OF THE PUPIL

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 1% BASE OMIDRIA OMEROS N205388 May 30, 2014 RX SOLUTION IRRIGATION Dec. 8, 2020 NEW PATIENT POPULATION
EQ 1% BASE OMIDRIA OMEROS N205388 May 30, 2014 RX SOLUTION IRRIGATION June 8, 2021 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Alpha-1A adrenergic receptor GPCR AGONIST Ki 5.30 WOMBAT-PK CHEMBL
Alpha-1D adrenergic receptor GPCR AGONIST IC50 5.90 WOMBAT-PK CHEMBL
Alpha-1B adrenergic receptor GPCR AGONIST Ki 6.90 WOMBAT-PK CHEMBL
Adrenergic receptor alpha-2 GPCR Ki 6.41 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 4.89 CHEMBL
Adrenergic receptor alpha-1 GPCR Ki 5.21 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 6.03 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 5.90 CHEMBL
Adrenergic receptor alpha-2 GPCR Ki 6.57 CHEMBL

External reference:

IDSource
4017847 VUID
N0000146204 NUI
C0031469 UMLSCUI
D00511 KEGG_DRUG
04JA59TNSJ UNII
61-76-7 SECONDARY_CAS_RN
4174 INN_ID
54765002 SNOMEDCT_US
4017847 VANDF
8163 RXNORM
372771005 SNOMEDCT_US
5282 MMSL
d00704 MMSL
001825 NDDF
6041 PUBCHEM_CID
CHEBI:8093 CHEBI
CHEMBL1215 ChEMBL_ID
DB00388 DRUGBANK_ID
CHEMBL1200339 ChEMBL_ID
D010656 MESH_DESCRIPTOR_UI
CHEMBL2062264 ChEMBL_ID
485 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fresh Clear HUMAN PRESCRIPTION DRUG LABEL 1 0023-0000 SOLUTION/ DROPS 1.20 mg OPHTHALMIC EXPORT ONLY 1 sections
CHILDRENS DIMETAPP COLD AND COUGH HUMAN OTC DRUG LABEL 3 0031-2234 LIQUID 2.50 mg ORAL OTC MONOGRAPH FINAL 9 sections
CHILDRENS DIMETAPP COLD AND ALLERGY HUMAN OTC DRUG LABEL 2 0031-2235 LIQUID 2.50 mg ORAL OTC MONOGRAPH FINAL 9 sections
CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION HUMAN OTC DRUG LABEL 2 0031-2247 LIQUID 2.50 mg ORAL OTC MONOGRAPH FINAL 9 sections
Childrens Dimetapp Multi-Symptom Cold and Flu HUMAN OTC DRUG LABEL 3 0031-2249 LIQUID 5 mg ORAL UNAPPROVED DRUG OTHER 9 sections
Childrens Dimetapp Multi-Symptom Cold Relief Dye-Free HUMAN OTC DRUG LABEL 3 0031-2295 SOLUTION 5 mg ORAL OTC MONOGRAPH FINAL 9 sections
Childrens Robitussin Cough and Cold CF HUMAN OTC DRUG LABEL 3 0031-8716 LIQUID 2.50 mg ORAL OTC MONOGRAPH FINAL 9 sections
ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU HUMAN OTC DRUG LABEL 3 0031-8721 CAPSULE, LIQUID FILLED 5 mg ORAL OTC MONOGRAPH FINAL 9 sections
Robitussin Peak Cold Multi-Symptom Cold HUMAN OTC DRUG LABEL 3 0031-8742 LIQUID 5 mg ORAL OTC MONOGRAPH FINAL 9 sections
Robitussin Severe Multi-Symptom Cough Cold Flu HUMAN OTC DRUG LABEL 4 0031-8751 LIQUID 10 mg ORAL OTC MONOGRAPH FINAL 9 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 10 mg ORAL OTC MONOGRAPH FINAL 9 sections
Cyclomydril HUMAN PRESCRIPTION DRUG LABEL 2 0065-0359 SOLUTION/ DROPS 10 mg OPHTHALMIC ANDA 12 sections
4 Way HUMAN OTC DRUG LABEL 1 0067-2086 SPRAY 10 mg NASAL OTC monograph final 9 sections
Theraflu HUMAN OTC DRUG LABEL 3 0067-6094 POWDER, FOR SOLUTION 10 mg ORAL OTC monograph final 9 sections
THERAFLU HUMAN OTC DRUG LABEL 3 0067-6095 POWDER, FOR SOLUTION 10 mg ORAL OTC monograph final 9 sections
THERAFLU HUMAN OTC DRUG LABEL 3 0067-6426 POWDER, FOR SOLUTION 10 mg ORAL OTC monograph final 9 sections
Theraflu HUMAN OTC DRUG LABEL 3 0067-7916 POWDER, FOR SOLUTION 10 mg ORAL OTC monograph final 9 sections
Theraflu HUMAN OTC DRUG LABEL 3 0067-7917 POWDER, FOR SOLUTION 10 mg ORAL OTC monograph final 9 sections
THERAFLU HUMAN OTC DRUG LABEL 3 0067-7918 POWDER, FOR SOLUTION 10 mg ORAL OTC monograph final 9 sections
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 6 0067-7919 KIT 10 mg None OTC monograph final 9 sections
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 6 0067-7919 KIT 10 mg None OTC monograph final 9 sections
THERAFLU HUMAN OTC DRUG LABEL 3 0067-7920 POWDER, FOR SOLUTION 10 mg ORAL OTC monograph final 9 sections
Triaminic HUMAN OTC DRUG LABEL 2 0067-8105 SYRUP 2.50 mg ORAL OTC monograph final 9 sections
TRIAMINIC HUMAN OTC DRUG LABEL 2 0067-8106 SYRUP 2.50 mg ORAL OTC monograph final 9 sections
Triaminic HUMAN OTC DRUG LABEL 4 0067-8112 KIT 2.50 mg None OTC monograph final 10 sections
Triaminic HUMAN OTC DRUG LABEL 4 0067-8112 KIT 2.50 mg None OTC monograph final 10 sections
Triaminic HUMAN OTC DRUG LABEL 4 0067-8116 SUSPENSION 2.50 mg ORAL OTC monograph final 9 sections
Theraflu Nighttime Multi-Symptom Severe Cold Powder HUMAN OTC DRUG LABEL 3 0067-8124 POWDER 10 mg ORAL OTC monograph final 9 sections
Theraflu ExpressMax HUMAN OTC DRUG LABEL 6 0067-8125 KIT 10 mg None OTC monograph final 10 sections
Theraflu ExpressMax HUMAN OTC DRUG LABEL 6 0067-8125 KIT 10 mg None OTC monograph final 10 sections