loratadine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
histamine-H1 receptor antagonists, tricyclic compounds	1605	79794-75-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: loratadine claritin loracert loradex loratidine loratyne	A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness. Molecular weight: 382.89 Formula: C22H23ClN2O2 CLOGP: 5.05 LIPINSKI: 1 HAC: 4 HDO: 0 TPSA: 42.43 ALOGS: -4.46 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

loratadine
claritin
loracert
loradex
loratidine
loratyne

A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.

Molecular weight: 382.89
Formula: C22H23ClN2O2
CLOGP: 5.05
LIPINSKI: 1
HAC: 4
HDO: 0
TPSA: 42.43
ALOGS: -4.46
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
10	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.01 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	5 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.44 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	40 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
April 12, 1993	FDA	BAYER HEALTHCARE LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Extra dose administered	294.31	9.83	149	79928	4927	50520120
Accidental exposure to product by child	175.63	9.83	65	80012	975	50524072
Drug ineffective	171.72	9.83	693	79384	818640	49706407
Contraindicated product administered	171.71	9.83	18	80059	148940	50376107
Gastrooesophageal reflux disease	152.90	9.83	359	79718	76069	50448978
Synovitis	145.26	9.83	14	80063	123851	50401196
Pneumonia aspiration	137.35	9.83	205	79872	30799	50494248
Glossodynia	135.69	9.83	13	80064	115556	50409491
Drug intolerance	133.06	9.83	92	79985	219012	50306035
Hand deformity	123.87	9.83	9	80068	100190	50424857
Systemic lupus erythematosus	123.00	9.83	35	80042	140587	50384460
Failure of child resistant product closure	117.78	9.83	23	80054	9	50525038
Treatment failure	113.65	9.83	38	80039	137599	50387448
Wound	107.20	9.83	19	80058	105775	50419272
Urticaria	101.38	9.83	440	79637	129121	50395926
Arthropathy	93.58	9.83	68	80009	157838	50367209
Joint swelling	92.12	9.83	154	79923	245132	50279915
Maternal exposure during pregnancy	89.35	9.83	73	80004	159705	50365342
Asthma	88.81	9.83	327	79750	89010	50436037
Pericarditis	86.91	9.83	11	80066	78678	50446369
Somnolence	82.59	9.83	472	79605	154513	50370534
Off label use	73.07	9.83	446	79631	473980	50051067
Therapeutic product effect decreased	72.58	9.83	65	80012	135985	50389062
Toxicity to various agents	66.20	9.83	149	79928	212350	50312697
Rheumatoid arthritis	63.11	9.83	142	79935	202408	50322639
Dizziness	60.95	9.83	825	79252	345544	50179503
General physical health deterioration	59.60	9.83	83	79994	142351	50382696
Coma	58.02	9.83	210	79867	56669	50468378
Alopecia	57.58	9.83	197	79880	244850	50280197
Cholecystitis chronic	56.39	9.83	73	80004	9596	50515451
Swelling face	56.05	9.83	197	79880	52398	50472649
Drug abuse	55.93	9.83	13	80064	59833	50465214
Anxiety	55.04	9.83	474	79603	177132	50347915
Butterfly rash	53.87	9.83	30	80047	1206	50523841
Hepatic enzyme increased	51.75	9.83	86	79991	137294	50387753
Infective pulmonary exacerbation of cystic fibrosis	51.35	9.83	63	80014	7846	50517201
Muscle spasms	49.89	9.83	355	79722	125198	50399849
Feeling abnormal	48.23	9.83	352	79725	125140	50399907
Insomnia	47.20	9.83	453	79624	174412	50350635
Chest discomfort	46.49	9.83	278	79799	92444	50432603
Acute kidney injury	45.40	9.83	196	79881	227862	50297185
Swelling	44.82	9.83	165	79912	200707	50324340
Helicobacter infection	44.12	9.83	12	80065	49690	50475357
Lower respiratory tract infection	43.39	9.83	52	80025	95149	50429898
Headache	41.39	9.83	1071	79006	505464	50019583
Pruritus	41.35	9.83	654	79423	282914	50242133
Palpitations	40.95	9.83	273	79804	94233	50430814
Cough	40.86	9.83	571	79506	240693	50284354
Angioedema	39.17	9.83	140	79937	37536	50487511
Dyspnoea	39.14	9.83	1138	78939	546470	49978577
C-reactive protein increased	38.86	9.83	29	80048	66445	50458602
Folliculitis	37.70	9.83	8	80069	39217	50485830
Sinusitis	37.57	9.83	424	79653	170134	50354913
Emotional distress	37.38	9.83	115	79962	28548	50496499
Discomfort	36.21	9.83	73	80004	108307	50416740
Sleep disorder due to general medical condition, insomnia type	35.69	9.83	4	80073	31443	50493604
Depression	34.98	9.83	408	79669	165015	50360032
Gallbladder disorder	34.92	9.83	80	79997	16662	50508385
Bronchitis	34.36	9.83	282	79795	103877	50421170
Seasonal allergy	33.85	9.83	73	80004	14603	50510444
Periorbital oedema	32.66	9.83	40	80037	4972	50520075
Dermatitis atopic	32.55	9.83	34	80043	3552	50521495
Tinnitus	32.26	9.83	108	79969	28024	50497023
Pancytopenia	31.26	9.83	53	80024	83977	50441070
Musculoskeletal stiffness	30.33	9.83	103	79974	128378	50396669
Lip swelling	29.29	9.83	96	79981	24640	50500407
Product dose omission issue	29.07	9.83	430	79647	183408	50341639
Rhinitis allergic	28.21	9.83	45	80032	7155	50517892
Impaired healing	27.86	9.83	42	80035	69744	50455303
Mobility decreased	27.43	9.83	53	80024	79895	50445152
Sinus disorder	26.86	9.83	77	80000	18381	50506666
Allergy test positive	26.77	9.83	13	80064	392	50524655
Knee arthroplasty	26.10	9.83	12	80065	35834	50489213
Infection	25.77	9.83	164	79913	172790	50352257
Multiple organ dysfunction syndrome	25.70	9.83	25	80052	50312	50474735
Nasal congestion	25.44	9.83	153	79924	50967	50474080
Diarrhoea	25.07	9.83	1154	78923	587322	49937725
Throat irritation	24.61	9.83	104	79973	30135	50494912
Chest pain	24.26	9.83	404	79673	176478	50348569
Upper respiratory tract infection	24.24	9.83	183	79894	65715	50459332
C-reactive protein abnormal	24.15	9.83	7	80070	27802	50497245
Acquired haemophilia	24.08	9.83	16	80061	887	50524160
Photosensitivity reaction	24.01	9.83	59	80018	12852	50512195
Malignant neoplasm progression	23.51	9.83	45	80032	68079	50456968
Tinea pedis	23.49	9.83	18	80059	1251	50523796
Head discomfort	23.37	9.83	53	80024	10966	50514081
Abdominal discomfort	22.94	9.83	245	79832	231396	50293651
Rhabdomyolysis	22.84	9.83	17	80060	39010	50486037
Therapeutic product effect incomplete	22.53	9.83	72	80005	91443	50433604
Injury	22.19	9.83	143	79934	48782	50476265
Anaphylactic reaction	22.12	9.83	154	79923	53901	50471146
Essential hypertension	22.02	9.83	31	80046	4413	50520634
Multiple allergies	21.74	9.83	44	80033	8419	50516628
Ill-defined disorder	21.71	9.83	33	80044	54621	50470426
Hepatocellular injury	21.68	9.83	7	80070	25940	50499107
Hypersomnia	21.43	9.83	63	80014	15251	50509796
Biliary dyskinesia	21.07	9.83	23	80054	2527	50522520
Expired product administered	20.22	9.83	33	80044	5349	50519698
Drug resistance	20.14	9.83	3	80074	18986	50506061
Gastrointestinal disorder	20.13	9.83	79	79998	94377	50430670
Feeling hot	19.93	9.83	118	79959	39084	50485963
Blister	19.80	9.83	69	80008	85349	50439698
Deep vein thrombosis	19.30	9.83	189	79888	73115	50451932
Wheezing	18.87	9.83	165	79912	61882	50463165
Nervousness	18.68	9.83	90	79987	27561	50497486
Cystitis noninfective	18.34	9.83	13	80064	801	50524246
Migraine	18.33	9.83	191	79886	75089	50449958
Paraesthesia	18.11	9.83	279	79798	119964	50405083
Status asthmaticus	18.07	9.83	13	80064	820	50524227
Dry mouth	17.92	9.83	151	79926	56027	50469020
Cholelithiasis	17.85	9.83	112	79965	37861	50487186
Oropharyngeal pain	17.83	9.83	195	79882	77606	50447441
Abdominal distension	17.77	9.83	185	79892	72718	50452329
Lupus hepatitis	17.71	9.83	5	80072	29	50525018
Renal impairment	17.61	9.83	61	80016	75600	50449447
Completed suicide	17.20	9.83	130	79947	131759	50393288
Throat tightness	17.20	9.83	72	80005	20775	50504272
Premature baby	17.09	9.83	4	80073	18333	50506714
Sinus headache	17.01	9.83	28	80049	4570	50520477
Gallbladder injury	16.92	9.83	15	80062	1279	50523768
Vision blurred	16.61	9.83	194	79883	78453	50446594
Thrombocytopenia	16.58	9.83	126	79951	127547	50397500
Product use issue	16.49	9.83	154	79923	149321	50375726
Hyperkalaemia	16.39	9.83	32	80045	48057	50476990
Allergic cystitis	16.35	9.83	3	80074	0	50525047
Septic shock	16.26	9.83	42	80035	57133	50467914
Victim of chemical submission	16.07	9.83	8	80069	255	50524792
Condition aggravated	16.05	9.83	353	79724	296705	50228342
Drug interaction	16.00	9.83	221	79856	199400	50325647
Basophil count decreased	15.91	9.83	6	80071	95	50524952
Hip arthroplasty	15.66	9.83	15	80062	30414	50494633
Reversible cerebral vasoconstriction syndrome	15.60	9.83	18	80059	2101	50522946
Arthralgia	15.57	9.83	553	79524	438149	50086898
Neuropathy peripheral	15.54	9.83	227	79850	96530	50428517
Sopor	15.52	9.83	6	80071	19873	50505174
Cardiac failure	15.32	9.83	65	80012	75975	50449072
Osteonecrosis of jaw	14.57	9.83	18	80059	32508	50492539
Hepatotoxicity	14.51	9.83	13	80064	27213	50497834
Posterior reversible encephalopathy syndrome	14.43	9.83	3	80074	14925	50510122
Dyspepsia	14.43	9.83	180	79897	73917	50451130
Hyponatraemia	14.39	9.83	91	79986	96048	50428999
Incorrect dose administered	14.33	9.83	128	79949	48286	50476761
Suicidal ideation	14.19	9.83	142	79935	55243	50469804
Neurological examination abnormal	14.03	9.83	7	80070	224	50524823
Nausea	13.96	9.83	1296	78781	704102	49820945
Urinary tract infection	13.89	9.83	458	79619	223562	50301485
Pre-existing condition improved	13.80	9.83	33	80044	7064	50517983
Swollen tongue	13.80	9.83	85	79992	28545	50496502
Upper-airway cough syndrome	13.76	9.83	37	80040	8513	50516534
Initial insomnia	13.62	9.83	27	80050	5088	50519959
Bronchospasm	13.60	9.83	53	80024	14801	50510246
Mast cell activation syndrome	13.56	9.83	8	80069	359	50524688
Temperature intolerance	13.54	9.83	34	80043	7505	50517542
Abnormal dreams	13.53	9.83	39	80038	9338	50515709
Eye pruritus	13.39	9.83	47	80030	12487	50512560
Hepatic failure	13.30	9.83	19	80058	32264	50492783
Medication error	13.21	9.83	23	80054	36081	50488966
Hot flush	13.19	9.83	117	79960	44052	50480995
Snoring	13.05	9.83	21	80056	3363	50521684
Agranulocytosis	12.97	9.83	9	80068	21412	50503635
Back pain	12.92	9.83	447	79630	219583	50305464
Burning sensation	12.86	9.83	119	79958	45327	50479720
Leukopenia	12.83	9.83	59	80018	67469	50457578
Panic disorder	12.83	9.83	17	80060	2286	50522761
Xanthogranuloma	12.75	9.83	3	80074	7	50525040
Death	12.74	9.83	405	79672	324974	50200073
Cataract subcapsular	12.68	9.83	9	80068	556	50524491
Circulatory collapse	12.65	9.83	8	80069	19992	50505055
Oesophageal adenocarcinoma recurrent	12.65	9.83	4	80073	36	50525011
Eye swelling	12.49	9.83	64	80013	20080	50504967
Lactic acidosis	12.43	9.83	21	80056	33334	50491713
Red blood cell sedimentation rate increased	12.43	9.83	17	80060	29399	50495648
Pulmonary embolism	12.39	9.83	228	79849	101476	50423571
Sleep apnoea syndrome	12.23	9.83	72	80005	23796	50501251
Overdose	12.21	9.83	100	79977	99627	50425420
Mitral valve prolapse	12.17	9.83	16	80061	2134	50522913
Depressed level of consciousness	12.01	9.83	42	80035	51911	50473136
Somnambulism	11.94	9.83	25	80052	4899	50520148
Intentional product use issue	11.93	9.83	72	80005	76846	50448201
Acute hepatic failure	11.80	9.83	5	80072	15672	50509375
Infusion related reaction	11.76	9.83	193	79884	169364	50355683
Rash	11.74	9.83	823	79254	436648	50088399
Loss of personal independence in daily activities	11.71	9.83	64	80013	69986	50455061
Fracture	11.70	9.83	6	80071	16827	50508220
Cyclic vomiting syndrome	11.69	9.83	4	80073	47	50525000
Cytomegalovirus infection	11.62	9.83	7	80070	17955	50507092
Skin burning sensation	11.59	9.83	39	80038	10146	50514901
Autoimmune hepatitis	11.56	9.83	32	80045	7487	50517560
Pulmonary fibrosis	11.50	9.83	13	80064	24424	50500623
Ear congestion	11.49	9.83	15	80062	1988	50523059
Metastases to liver	11.45	9.83	9	80068	20095	50504952
Erythema	11.42	9.83	308	79769	146106	50378941
Biliary sepsis	11.41	9.83	10	80067	840	50524207
Chronic sinusitis	11.34	9.83	28	80049	6117	50518930
Presbyoesophagus	11.17	9.83	3	80074	14	50525033
Psoriasis	11.12	9.83	162	79915	68838	50456209
Red blood cell sedimentation rate abnormal	11.10	9.83	6	80071	16337	50508710
Dysgeusia	11.06	9.83	102	79975	38814	50486233
Palmar erythema	11.05	9.83	13	80064	1550	50523497
Acute sinusitis	10.98	9.83	20	80057	3540	50521507
Chronic spontaneous urticaria	10.96	9.83	8	80069	516	50524531
Hypoaesthesia	10.88	9.83	271	79806	126986	50398061
Bezoar	10.86	9.83	12	80065	1336	50523711
Cluster headache	10.82	9.83	8	80069	527	50524520
Premature delivery	10.70	9.83	13	80064	23650	50501397
Burns first degree	10.69	9.83	3	80074	17	50525030
Myelosuppression	10.69	9.83	4	80073	13513	50511534
Ear discomfort	10.67	9.83	29	80048	6715	50518332
Torsade de pointes	10.65	9.83	42	80035	11793	50513254
Sinus congestion	10.56	9.83	47	80030	13924	50511123
Full blood count decreased	10.56	9.83	66	80011	22280	50502767
Broad ligament tear	10.54	9.83	3	80074	18	50525029
Patellofemoral pain syndrome	10.49	9.83	8	80069	552	50524495
Myxoedema coma	10.47	9.83	7	80070	392	50524655
Pneumonia	10.34	9.83	713	79364	377688	50147359
Fatigue	10.33	9.83	1274	78803	706327	49818720
Multiple lentigines syndrome	10.23	9.83	5	80072	153	50524894
Restless legs syndrome	10.20	9.83	51	80026	15846	50509201
Chills	10.17	9.83	212	79865	96475	50428572
Incorrect dosage administered	10.09	9.83	13	80064	1701	50523346
Cerumen impaction	10.04	9.83	10	80067	988	50524059
Flushing	9.89	9.83	155	79922	66860	50458187

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Accidental exposure to product by child	289.93	10.69	96	38287	1258	29534886
Extra dose administered	222.95	10.69	99	38284	2978	29533166
Failure of child resistant product closure	76.99	10.69	16	38367	21	29536123
Drug abuse	68.11	10.69	11	38372	79872	29456272
Urticaria	59.63	10.69	181	38202	54479	29481665
General physical health deterioration	53.12	10.69	34	38349	102823	29433321
Infective pulmonary exacerbation of cystic fibrosis	51.00	10.69	51	38332	6185	29529959
Drug interaction	50.14	10.69	114	38269	197271	29338873
Rash	44.02	10.69	407	37976	189412	29346732
Fatigue	39.93	10.69	604	37779	316217	29219927
Off label use	39.58	10.69	229	38154	300571	29235573
Pruritus	39.34	10.69	273	38110	116576	29419568
Completed suicide	36.43	10.69	38	38345	90208	29445936
Toxicity to various agents	35.94	10.69	111	38272	173550	29362594
Asthma	35.88	10.69	111	38272	33738	29502406
Sinusitis	35.81	10.69	112	38271	34238	29501906
Drug ineffective	31.79	10.69	310	38073	362860	29173284
Acute kidney injury	30.21	10.69	211	38172	265056	29271088
Cough	28.95	10.69	271	38112	126456	29409688
Sinus disorder	28.68	10.69	37	38346	5918	29530226
Throat irritation	28.20	10.69	45	38338	8740	29527404
Chronic spontaneous urticaria	27.27	10.69	8	38375	68	29536076
Swelling face	26.65	10.69	72	38311	20278	29515866
Treatment failure	23.91	10.69	9	38374	36930	29499214
Gastrointestinal mucosal necrosis	21.04	10.69	8	38375	160	29535984
Bronchitis	19.43	10.69	97	38286	36771	29499373
Expired product administered	19.41	10.69	21	38362	2790	29533354
Infusion related reaction	19.39	10.69	110	38273	43776	29492368
CADASIL	18.99	10.69	6	38377	67	29536077
Magnetic resonance imaging spinal abnormal	18.67	10.69	6	38377	71	29536073
Dizziness	18.43	10.69	347	38036	189337	29346807
Visual evoked potentials abnormal	18.30	10.69	6	38377	76	29536068
Drug resistance	18.27	10.69	3	38380	21537	29514607
Eye pruritus	17.93	10.69	25	38358	4307	29531837
Oral pruritus	17.67	10.69	8	38375	252	29535892
Renal impairment	17.50	10.69	51	38332	81282	29454862
Glossodynia	16.97	10.69	21	38362	3222	29532922
Central nervous system inflammation	16.74	10.69	6	38377	101	29536043
Blood pH decreased	16.63	10.69	17	38366	2116	29534028
Wheezing	16.50	10.69	86	38297	33154	29502990
PO2 increased	16.40	10.69	10	38373	584	29535560
Tunnel vision	16.29	10.69	9	38374	436	29535708
Muscle spasms	16.28	10.69	142	38241	64940	29471204
Seasonal allergy	16.19	10.69	26	38357	5076	29531068
Hyperkalaemia	15.91	10.69	35	38348	61357	29474787
Interstitial lung disease	15.72	10.69	32	38351	57686	29478458
Pneumonitis	15.64	10.69	75	38308	27969	29508175
Saccadic eye movement	15.33	10.69	6	38377	130	29536014
Metamorphopsia	15.28	10.69	9	38374	493	29535651
Ejaculation delayed	15.18	10.69	7	38376	230	29535914
Lacrimation increased	14.99	10.69	30	38353	6950	29529194
Rheumatoid arthritis	14.78	10.69	12	38371	32140	29504004
Feeling abnormal	14.78	10.69	121	38262	54324	29481820
Tension headache	14.72	10.69	13	38370	1348	29534796
Rhabdomyolysis	14.69	10.69	36	38347	60772	29475372
Chills	14.55	10.69	149	38234	71151	29464993
Contraindicated product administered	14.51	10.69	3	38380	18263	29517881
Anxiety	14.49	10.69	172	38211	85193	29450951
Upper respiratory tract infection	14.44	10.69	72	38311	27277	29508867
Lip swelling	14.37	10.69	42	38341	12368	29523776
Chest pain	14.21	10.69	214	38169	111759	29424385
Vision blurred	14.16	10.69	95	38288	40081	29496063
Suicidal ideation	14.03	10.69	85	38298	34631	29501513
Leukopenia	13.87	10.69	32	38351	55171	29480973
Cerebral microangiopathy	13.81	10.69	6	38377	171	29535973
Heart rate increased	13.68	10.69	92	38291	38846	29497298
Muscle tightness	13.62	10.69	22	38361	4316	29531828
Double stranded DNA antibody positive	13.43	10.69	6	38377	183	29535961
Gastrooesophageal reflux disease	13.29	10.69	78	38305	31418	29504726
Intercepted medication error	13.17	10.69	8	38375	464	29535680
Conduction disorder	13.15	10.69	14	38369	1826	29534318
Burning sensation	13.10	10.69	48	38335	15890	29520254
Sleep apnoea syndrome	12.82	10.69	51	38332	17548	29518596
Forced expiratory volume decreased	12.80	10.69	17	38366	2796	29533348
Hyponatraemia	12.74	10.69	45	38338	67588	29468556
Acute respiratory distress syndrome	12.64	10.69	7	38376	22928	29513216
Chronic obstructive pulmonary disease	12.20	10.69	93	38290	40862	29495282
Testicular cyst	12.18	10.69	4	38379	51	29536093
Spinal osteoarthritis	12.10	10.69	26	38357	6330	29529814
Oropharyngeal pain	12.02	10.69	72	38311	29213	29506931
Blood cholesterol increased	12.01	10.69	46	38337	15549	29520595
Upper-airway cough syndrome	11.94	10.69	17	38366	2986	29533158
Metabolic acidosis	11.94	10.69	19	38364	37643	29498501
Lactic acidosis	11.90	10.69	13	38370	30234	29505910
Eosinophilia	11.88	10.69	7	38376	22154	29513990
Renal failure	11.72	10.69	98	38285	118501	29417643
Depression	11.69	10.69	165	38218	84982	29451162
C-reactive protein increased	11.66	10.69	25	38358	44238	29491906
Migraine	11.57	10.69	39	38344	12391	29523753
Cytomegalovirus infection	11.53	10.69	8	38375	23207	29512937
Intentional self-injury	11.51	10.69	39	38344	12422	29523722
Crying	11.49	10.69	23	38360	5328	29530816
Physical examination abnormal	11.29	10.69	6	38377	269	29535875
Insomnia	11.01	10.69	169	38214	88592	29447552
Convulsions local	10.99	10.69	3	38380	19	29536125
Pneumonia	10.97	10.69	514	37869	319658	29216486
Angioedema	10.96	10.69	75	38308	31840	29504304
Mucosal inflammation	10.93	10.69	15	38368	31580	29504564
Rhinorrhoea	10.90	10.69	56	38327	21463	29514681
Nasal congestion	10.90	10.69	51	38332	18828	29517316
Sneezing	10.74	10.69	20	38363	4394	29531750

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Extra dose administered	538.54	9.72	240	93048	6510	64398934
Accidental exposure to product by child	458.67	9.72	162	93126	2323	64403121
Failure of child resistant product closure	190.62	9.72	39	93249	36	64405408
Urticaria	160.22	9.72	523	92765	146794	64258650
Gastrooesophageal reflux disease	139.13	9.72	345	92943	82798	64322646
Drug ineffective	132.81	9.72	696	92592	839551	63565893
Drug abuse	124.20	9.72	21	93267	132353	64273091
Off label use	115.12	9.72	498	92790	632308	63773136
Infective pulmonary exacerbation of cystic fibrosis	97.49	9.72	102	93186	11694	64393750
Contraindicated product administered	97.06	9.72	19	93269	107810	64297634
General physical health deterioration	96.49	9.72	92	93196	204333	64201111
Toxicity to various agents	96.43	9.72	242	93046	363271	64042173
Synovitis	88.06	9.72	18	93270	99072	64306372
Drug intolerance	84.81	9.72	88	93200	187904	64217540
Asthma	82.67	9.72	314	92974	94911	64310533
Acute kidney injury	79.43	9.72	357	92931	448883	63956561
Pruritus	78.84	9.72	743	92545	311657	64093787
Swelling face	76.26	9.72	223	93065	58943	64346501
Treatment failure	75.86	9.72	37	93251	116779	64288665
Somnolence	68.68	9.72	517	92771	203128	64202316
Dizziness	68.56	9.72	935	92353	429228	63976216
Drug interaction	61.41	9.72	292	92996	361791	64043653
Joint swelling	61.32	9.72	138	93150	215244	64190200
Hand deformity	61.02	9.72	9	93279	62762	64342682
Pneumonia aspiration	59.53	9.72	205	93083	59066	64346378
Butterfly rash	57.66	9.72	30	93258	1152	64404292
Rheumatoid arthritis	52.93	9.72	98	93190	164196	64241248
C-reactive protein increased	49.25	9.72	39	93249	94870	64310574
Therapeutic product effect decreased	48.69	9.72	57	93231	115294	64290150
Cholecystitis chronic	47.81	9.72	63	93225	9224	64396220
Completed suicide	47.41	9.72	166	93122	224248	64181196
Muscle spasms	46.93	9.72	357	92931	140666	64264778
Throat irritation	45.75	9.72	127	93161	32584	64372860
Angioedema	44.20	9.72	192	93096	61629	64343815
Headache	43.89	9.72	1038	92250	528429	63877015
Feeling abnormal	43.78	9.72	337	92951	133265	64272179
Emotional distress	42.81	9.72	132	93156	35906	64369538
Lip swelling	42.78	9.72	122	93166	31785	64373659
Anxiety	41.94	9.72	463	92825	202186	64203258
Pericarditis	41.81	9.72	19	93269	62497	64342947
Cough	41.40	9.72	640	92648	301508	64103936
Glossodynia	41.22	9.72	21	93267	64675	64340769
Chest discomfort	40.36	9.72	297	92991	115809	64289635
Sinusitis	40.24	9.72	354	92934	145574	64259870
Palpitations	40.24	9.72	274	93014	104214	64301230
Wound	40.21	9.72	31	93257	76446	64328998
Systemic lupus erythematosus	40.13	9.72	32	93256	77580	64327864
Dyspnoea	40.01	9.72	1339	91949	717335	63688109
Expired product administered	39.49	9.72	46	93242	5941	64399503
Rash	39.21	9.72	903	92385	457646	63947798
Insomnia	39.12	9.72	448	92840	197388	64208056
Renal impairment	38.82	9.72	86	93202	134931	64270513
Chest pain	38.75	9.72	516	92772	235464	64169980
Fatigue	38.43	9.72	1382	91906	747348	63658096
Pancytopenia	38.23	9.72	95	93193	143214	64262230
Arthropathy	37.34	9.72	74	93214	120893	64284551
Rhabdomyolysis	36.94	9.72	47	93241	91679	64313765
Rhinitis allergic	34.38	9.72	50	93238	8028	64397416
Helicobacter infection	34.01	9.72	7	93281	38355	64367089
Maternal exposure during pregnancy	32.85	9.72	55	93233	95829	64309615
Hyperkalaemia	32.84	9.72	60	93228	101069	64304375
Bronchitis	32.71	9.72	269	93019	108474	64296970
Drug resistance	31.97	9.72	6	93282	35096	64370348
Tinnitus	31.64	9.72	115	93173	34018	64371426
Nasal congestion	31.61	9.72	170	93118	59488	64345956
Vision blurred	30.80	9.72	230	93058	90086	64315358
Injury	29.97	9.72	160	93128	55832	64349612
Thrombocytopenia	29.96	9.72	195	93093	223606	64181838
Hepatocellular injury	29.85	9.72	14	93274	45221	64360223
Wheezing	29.08	9.72	208	93080	80371	64325073
Gallbladder disorder	28.81	9.72	71	93217	16959	64388485
C-reactive protein abnormal	28.61	9.72	4	93284	29043	64376401
Eye pruritus	28.36	9.72	59	93229	12600	64392844
Dermatitis atopic	27.62	9.72	31	93257	3845	64401599
Head discomfort	27.50	9.72	56	93232	11778	64393666
Sopor	27.16	9.72	5	93283	29656	64375788
Allergy test positive	26.97	9.72	13	93275	423	64405021
Upper respiratory tract infection	26.91	9.72	189	93099	72596	64332848
Leukopenia	26.31	9.72	68	93220	101174	64304270
Product dose omission issue	25.68	9.72	410	92878	194337	64211107
Multiple organ dysfunction syndrome	25.68	9.72	69	93219	101344	64304100
Cytomegalovirus infection	25.35	9.72	11	93277	37188	64368256
Burning sensation	25.28	9.72	140	93148	49524	64355920
Chronic spontaneous urticaria	25.21	9.72	13	93275	490	64404954
Lactic acidosis	25.21	9.72	31	93257	61379	64344065
Sinus disorder	24.99	9.72	67	93221	16841	64388603
Status asthmaticus	24.38	9.72	16	93272	952	64404492
Oropharyngeal pain	24.18	9.72	215	93073	88652	64316792
Renal failure	23.96	9.72	159	93129	181529	64223915
Coma	23.85	9.72	212	93076	87403	64318041
Migraine	23.32	9.72	163	93125	62514	64342930
Depression	23.09	9.72	383	92905	182908	64222536
Photosensitivity reaction	22.93	9.72	68	93220	18105	64387339
Sleep disorder due to general medical condition, insomnia type	22.86	9.72	5	93283	26265	64379179
Malignant neoplasm progression	22.81	9.72	85	93203	112786	64292658
Infection	21.84	9.72	167	93121	184713	64220731
Deep vein thrombosis	21.59	9.72	240	93048	104942	64300502
Septic shock	21.57	9.72	79	93209	105358	64300086
Interstitial lung disease	21.49	9.72	71	93217	97661	64307783
Acute respiratory distress syndrome	21.48	9.72	15	93273	38920	64366524
Circulatory collapse	21.41	9.72	11	93277	33721	64371723
Chills	21.21	9.72	297	92991	136967	64268477
Therapeutic product effect incomplete	20.86	9.72	78	93210	103404	64302040
Periorbital oedema	20.80	9.72	38	93250	7376	64398068
Hepatic failure	20.66	9.72	30	93258	55364	64350080
Lower respiratory tract infection	20.62	9.72	69	93219	94545	64310899
Cardiac failure	20.53	9.72	110	93178	132263	64273181
Drug level increased	20.47	9.72	12	93276	34184	64371260
Overdose	20.36	9.72	141	93147	159425	64246019
Swollen tongue	20.16	9.72	102	93186	34852	64370592
Bone marrow failure	19.90	9.72	24	93264	47928	64357516
Myelosuppression	19.82	9.72	5	93283	23825	64381619
Gallbladder injury	19.68	9.72	15	93273	1133	64404311
Oral pruritus	19.37	9.72	18	93270	1787	64403657
Hypotension	19.05	9.72	413	92875	380561	64024883
Acquired haemophilia	19.03	9.72	17	93271	1603	64403841
Gastrointestinal mucosal necrosis	18.81	9.72	8	93280	193	64405251
Back pain	18.42	9.72	483	92805	249688	64155756
Nervousness	18.30	9.72	88	93200	29468	64375976
Agranulocytosis	18.25	9.72	17	93271	38212	64367232
Throat tightness	18.16	9.72	74	93214	23086	64382358
Incorrect dose administered	18.10	9.72	150	93138	60615	64344829
Incorrect dosage administered	17.95	9.72	19	93269	2207	64403237
Product quality issue	17.93	9.72	88	93200	29711	64375733
Sinus headache	17.85	9.72	26	93262	4181	64401263
Folliculitis	17.38	9.72	11	93277	30066	64375378
Feeling hot	17.13	9.72	119	93169	45544	64359900
Hypersomnia	17.08	9.72	65	93223	19652	64385792
Hyponatraemia	17.04	9.72	135	93153	148204	64257240
Biliary dyskinesia	16.95	9.72	19	93269	2353	64403091
Intentional product use issue	16.65	9.72	76	93212	95288	64310156
Allergic cystitis	16.62	9.72	3	93285	0	64405444
Hepatic enzyme increased	16.48	9.72	115	93173	129828	64275616
Mobility decreased	16.47	9.72	66	93222	85774	64319670
Osteonecrosis of jaw	16.45	9.72	20	93268	39805	64365639
Red blood cell sedimentation rate increased	15.99	9.72	13	93275	31222	64374222
Cerebral haemorrhage	15.98	9.72	31	93257	51059	64354385
Seasonal allergy	15.88	9.72	45	93243	11681	64393763
Cystitis noninfective	15.84	9.72	13	93275	1093	64404351
Transplant rejection	15.79	9.72	3	93285	17398	64388046
Victim of chemical submission	15.75	9.72	8	93280	292	64405152
Altered state of consciousness	15.69	9.72	19	93269	37883	64367561
Hepatotoxicity	15.55	9.72	21	93267	39941	64365503
Melaena	15.47	9.72	34	93254	53514	64351930
Paraesthesia	15.45	9.72	277	93011	134245	64271199
Knee arthroplasty	15.43	9.72	10	93278	26989	64378455
Initial insomnia	15.35	9.72	29	93259	5775	64399669
Transient ischaemic attack	15.33	9.72	113	93175	44069	64361375
Nausea	15.18	9.72	1326	91962	784474	63620970
Discomfort	15.01	9.72	63	93225	80815	64324629
Impaired healing	14.67	9.72	42	93246	60431	64345013
Administration site inflammation	14.55	9.72	3	93285	3	64405441
Chronic obstructive pulmonary disease	14.52	9.72	162	93126	70886	64334558
Urinary tract infection	14.49	9.72	438	92850	231158	64174286
Condition aggravated	14.48	9.72	419	92869	372007	64033437
Upper-airway cough syndrome	14.24	9.72	36	93252	8734	64396710
Anaphylactic reaction	14.23	9.72	157	93131	68507	64336937
Crying	14.05	9.72	62	93226	20028	64385416
Hyperlipidaemia	13.93	9.72	68	93220	22908	64382536
Status epilepticus	13.84	9.72	7	93281	21656	64383788
Reversible cerebral vasoconstriction syndrome	13.81	9.72	17	93271	2325	64403119
Posterior reversible encephalopathy syndrome	13.81	9.72	8	93280	22938	64382506
Burns first degree	13.53	9.72	4	93284	31	64405413
Polyneuropathy	13.37	9.72	6	93282	19888	64385556
Blood pressure fluctuation	13.35	9.72	35	93253	51836	64353608
Carotid artery disease	13.24	9.72	16	93272	2147	64403297
Panic disorder	13.12	9.72	18	93270	2739	64402705
Oesophageal adenocarcinoma recurrent	13.00	9.72	4	93284	36	64405408
Autoimmune hepatitis	12.98	9.72	38	93250	10046	64395398
Dry mouth	12.92	9.72	139	93149	60279	64345165
Dyspepsia	12.90	9.72	175	93113	80137	64325307
Bronchial hyperreactivity	12.87	9.72	17	93271	2495	64402949
Musculoskeletal stiffness	12.85	9.72	115	93173	123091	64282353
Eye swelling	12.84	9.72	65	93223	22216	64383228
Hypoaesthesia	12.79	9.72	277	93011	138831	64266613
Patellofemoral pain syndrome	12.67	9.72	8	93280	445	64404999
Pneumonia	12.67	9.72	956	92332	558620	63846824
Cardiogenic shock	12.65	9.72	17	93271	32410	64373034
Erythema	12.57	9.72	357	92931	186713	64218731
Breast pain	12.54	9.72	30	93258	7031	64398413
Red blood cell sedimentation rate abnormal	12.49	9.72	4	93284	16302	64389142
Multiple lentigines syndrome	12.48	9.72	6	93282	194	64405250
Flushing	12.48	9.72	171	93117	78477	64326967
Neutropenia	12.47	9.72	258	93030	239366	64166078
Full blood count decreased	12.40	9.72	65	93223	22517	64382927
Pulmonary fibrosis	12.35	9.72	15	93273	29863	64375581
Tinea pedis	12.22	9.72	15	93273	2046	64403398
Respiratory failure	12.19	9.72	162	93126	161021	64244423
Basophil count decreased	12.15	9.72	6	93282	206	64405238
Heart rate decreased	12.11	9.72	40	93248	55027	64350417
Eczema	12.07	9.72	79	93209	29641	64375803
Syncope	12.07	9.72	306	92982	157329	64248115
Neuroleptic malignant syndrome	12.07	9.72	11	93277	24985	64380459
Heart rate increased	11.98	9.72	205	93083	98470	64306974
Neurological examination abnormal	11.72	9.72	8	93280	508	64404936
Ear congestion	11.71	9.72	15	93273	2135	64403309
Cardio-respiratory arrest	11.55	9.72	89	93199	98304	64307140
Coronary artery disease	11.54	9.72	136	93152	60297	64345147
Pulmonary embolism	11.47	9.72	285	93003	146071	64259373
Cystic fibrosis	11.46	9.72	19	93269	3415	64402029
Face oedema	11.42	9.72	68	93220	24693	64380751
Essential hypertension	11.39	9.72	24	93264	5170	64400274
Mitral valve prolapse	11.38	9.72	14	93274	1913	64403531
Cholelithiasis	11.31	9.72	108	93180	45398	64360046
Pneumocystis jirovecii pneumonia	11.29	9.72	14	93274	27620	64377824
Death	11.26	9.72	577	92711	482128	63923316
Blood creatinine increased	11.19	9.72	134	93154	135648	64269796
Intervertebral disc degeneration	11.15	9.72	43	93245	13077	64392367
Intercepted medication error	11.08	9.72	9	93279	746	64404698
Laryngeal pain	11.07	9.72	25	93263	5643	64399801
Neurotoxicity	11.07	9.72	14	93274	27390	64378054
Sinus congestion	11.07	9.72	48	93240	15391	64390053
Palmar erythema	11.05	9.72	13	93275	1697	64403747
Cholestasis	11.00	9.72	31	93257	44841	64360603
Skin burning sensation	10.97	9.72	37	93251	10546	64394898
Bronchospasm	10.95	9.72	61	93227	21621	64383823
Visual impairment	10.92	9.72	159	93129	73918	64331526
Aspergillus infection	10.91	9.72	5	93283	16374	64389070
Bone pain	10.90	9.72	111	93177	47461	64357983
Rash pruritic	10.88	9.72	129	93159	57275	64348169
Anuria	10.87	9.72	7	93281	18957	64386487
Depressed level of consciousness	10.86	9.72	71	93217	81365	64324079
Ventricular hypertrophy	10.84	9.72	27	93261	6489	64398955
Haemophagocytic lymphohistiocytosis	10.80	9.72	6	93282	17603	64387841
Exposure to toxic agent	10.76	9.72	26	93262	6133	64399311
Nasal oedema	10.71	9.72	10	93278	998	64404446
Nephropathy toxic	10.69	9.72	6	93282	17508	64387936
Suicidal ideation	10.69	9.72	145	93143	66397	64339047
Therapy non-responder	10.64	9.72	54	93234	65845	64339599
Ear infection	10.62	9.72	64	93224	23340	64382104
Allergy to animal	10.61	9.72	10	93278	1011	64404433
Rotator cuff syndrome	10.56	9.72	40	93248	12067	64393377
Non-cardiac chest pain	10.50	9.72	32	93256	8648	64396796
Lymphopenia	10.48	9.72	13	93275	25644	64379800
Emotional disorder	10.46	9.72	41	93247	12566	64392878
Carpal tunnel syndrome	10.43	9.72	48	93240	15780	64389664
Metabolic acidosis	10.43	9.72	60	93228	70898	64334546
Chronic sinusitis	10.40	9.72	26	93262	6266	64399178
Bradycardia	10.39	9.72	115	93173	118104	64287340
Pneumonitis	10.36	9.72	115	93173	50250	64355194
Paraesthesia oral	10.33	9.72	42	93246	13089	64392355
Accident at home	10.25	9.72	5	93283	167	64405277
Tunnel vision	10.25	9.72	10	93278	1055	64404389
Mood altered	10.20	9.72	48	93240	15931	64389513
Aphthous ulcer	10.18	9.72	3	93285	12903	64392541
Hypertensive crisis	10.11	9.72	7	93281	18241	64387203
Uterine cyst	10.07	9.72	6	93282	301	64405143
Lethargy	10.00	9.72	154	93134	72440	64333004
Abdominal pain upper	9.88	9.72	327	92961	174703	64230741
Cataract subcapsular	9.80	9.72	9	93279	880	64404564
Disseminated intravascular coagulation	9.79	9.72	20	93268	32328	64373116
Serotonin syndrome	9.73	9.72	27	93261	39255	64366189

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	R06AX13	RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Other antihistamines for systemic use
CHEBI has role	CHEBI:37955	H1 receptor antagonists
CHEBI has role	CHEBI:48873	acetylcholine receptor antagonist
CHEBI has role	CHEBI:50857	anti-allergic drugs
CHEBI has role	CHEBI:176497	geroprotectors
MeSH PA	D018926	Anti-Allergic Agents
MeSH PA	D000982	Antipruritics
MeSH PA	D003879	Dermatologic Agents
MeSH PA	D018494	Histamine Agents
MeSH PA	D006633	Histamine Antagonists
MeSH PA	D006634	Histamine H1 Antagonists
MeSH PA	D039563	Histamine H1 Antagonists, Non-Sedating
MeSH PA	D018377	Neurotransmitter Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Vasomotor rhinitis	indication	8229003	DOID:4730
Allergic rhinitis	indication	61582004
Nasal discharge	indication	64531003
Nasal congestion	indication	68235000
Sneezing	indication	76067001
Common cold	indication	82272006	DOID:10459
Chronic idiopathic urticaria	indication	302162004
Seasonal allergic rhinitis	indication	367498001
Allergic conjunctivitis	indication	473460002	DOID:11204
Bone pain after neupogen	off-label use	12584003
Urticaria	off-label use	126485001
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763
Coronary arteriosclerosis	contraindication	53741008	DOID:3393
Hepatic failure	contraindication	59927004
Diabetes mellitus	contraindication	73211009	DOID:9351
Kidney disease	contraindication	90708001	DOID:557
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409
Benign prostatic hyperplasia	contraindication	266569009
Retention of urine	contraindication	267064002
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Hypertensive urgency	contraindication	443482000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.43	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN	ANTAGONIST	Ki	6.97	WOMBAT-PK	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		Ki	4.94	WOMBAT-PK
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	6.81	DRUG MATRIX
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN		EC50	5.52	CHEMBL
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	7.80	DRUG MATRIX
Potassium channel subfamily K member 9	Ion channel	Q9NPC2	KCNK9_HUMAN		IC50	4.20	CHEMBL
Bile acid receptor	Nuclear hormone receptor	Q96RI1	NR1H4_HUMAN		IC50	5.51	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	6.77	WOMBAT-PK
Sodium-dependent neutral amino acid transporter B(0)AT2	Transporter	Q9H2J7	S6A15_HUMAN		IC50	5.40	CHEMBL
Histamine H1 receptor	GPCR		HRH1_CAVPO		Kd	7.14	CHEMBL
Histamine H1 receptor	GPCR		HRH1_RAT		Ki	6.46	CHEMBL

External reference:

ID	Source
4020716	VUID
N0000148306	NUI
D00364	KEGG_DRUG
4020716	VANDF
C0065180	UMLSCUI
CHEBI:6538	CHEBI
CHEMBL998	ChEMBL_ID
DB00455	DRUGBANK_ID
D017336	MESH_DESCRIPTOR_UI
3957	PUBCHEM_CID
7216	IUPHAR_LIGAND_ID
5864	INN_ID
7AJO3BO7QN	UNII
203576	RXNORM
191	MMSL
45829	MMSL
4994	MMSL
d03050	MMSL
003909	NDDF
015760	NDDF
108652002	SNOMEDCT_US
386884002	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
allergy relief	HUMAN OTC DRUG LABEL	1	0067-6066	TABLET	10 mg	ORAL	NDA	15 sections
allergy relief	HUMAN OTC DRUG LABEL	1	0067-6122	TABLET	10 mg	ORAL	NDA	15 sections
good sense allergy relief	HUMAN OTC DRUG LABEL	1	0113-0612	TABLET	10 mg	ORAL	ANDA	15 sections
Good Sense childrens allergy relief	HUMAN OTC DRUG LABEL	1	0113-0671	SOLUTION	5 mg	ORAL	ANDA	14 sections
good sense childrens allergy relief	HUMAN OTC DRUG LABEL	1	0113-1019	TABLET, CHEWABLE	5 mg	ORAL	ANDA	15 sections
good sense allergy relief	HUMAN OTC DRUG LABEL	1	0113-1191	TABLET, ORALLY DISINTEGRATING	10 mg	ORAL	ANDA	15 sections
good sense allergy relief	HUMAN OTC DRUG LABEL	1	0113-1612	TABLET	10 mg	ORAL	ANDA	15 sections
good sense childrens allergy relief	HUMAN OTC DRUG LABEL	1	0113-1719	SOLUTION	5 mg	ORAL	ANDA	14 sections
Allergy and Congestion Relief	HUMAN OTC DRUG LABEL	2	0113-2007	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	ANDA	14 sections
basic care childrens allergy relief	HUMAN OTC DRUG LABEL	1	0113-7500	TABLET, CHEWABLE	5 mg	ORAL	ANDA	15 sections
Basic Care allergy relief	HUMAN OTC DRUG LABEL	1	0113-7612	TABLET	10 mg	ORAL	ANDA	15 sections
Basic Care Childrens Allergy Relief	HUMAN OTC DRUG LABEL	1	0113-7671	SOLUTION	5 mg	ORAL	ANDA	14 sections
perrigo allergy d	HUMAN OTC DRUG LABEL	2	0113-7777	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	ANDA	15 sections
good sense allergy relief	HUMAN OTC DRUG LABEL	1	0113-9755	TABLET, ORALLY DISINTEGRATING	10 mg	ORAL	ANDA	15 sections
Childrens Loratadine	HUMAN OTC DRUG LABEL	1	0121-0849	SOLUTION	5 mg	ORAL	ANDA	16 sections
Loratadine	HUMAN OTC DRUG LABEL	1	0363-0522	TABLET	10 mg	ORAL	ANDA	15 sections
Loratadine	HUMAN OTC DRUG LABEL	1	0363-0527	TABLET, ORALLY DISINTEGRATING	10 mg	ORAL	ANDA	15 sections
Wal itin	HUMAN OTC DRUG LABEL	1	0363-0699	TABLET	10 mg	ORAL	ANDA	15 sections
Loratadine and Pseudoephedrine	HUMAN OTC DRUG LABEL	2	0363-0725	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	ANDA	16 sections
Loratadine	HUMAN OTC DRUG LABEL	1	0363-0752	TABLET, CHEWABLE	5 mg	ORAL	ANDA	16 sections
Wal-itin	HUMAN OTC DRUG LABEL	1	0363-0754	TABLET, CHEWABLE	5 mg	ORAL	ANDA	16 sections
Indoor Outdoor Allergy Relief	HUMAN OTC DRUG LABEL	1	0363-0858	TABLET	10 mg	ORAL	ANDA	14 sections
12 hour allergy and congestion	HUMAN OTC DRUG LABEL	2	0363-1133	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	ANDA	14 sections
allergy relief	HUMAN OTC DRUG LABEL	1	0363-1612	TABLET	10 mg	ORAL	ANDA	15 sections
allergy relief	HUMAN OTC DRUG LABEL	1	0363-1612	TABLET	10 mg	ORAL	ANDA	15 sections
WAL-ITIN	HUMAN OTC DRUG LABEL	1	0363-1686	CAPSULE, LIQUID FILLED	10 mg	ORAL	ANDA	16 sections
Wal-itin Allergy Relief	HUMAN OTC DRUG LABEL	1	0363-2085	SOLUTION	5 mg	ORAL	ANDA	15 sections
Childrens Wal-itin	HUMAN OTC DRUG LABEL	1	0363-2092	SOLUTION	5 mg	ORAL	ANDA	16 sections
Childrens Walitin	HUMAN OTC DRUG LABEL	1	0363-2108	SOLUTION	5 mg	ORAL	ANDA	16 sections
Childrens Loratadine Sugar Free	HUMAN OTC DRUG LABEL	1	0363-2131	SOLUTION	5 mg	ORAL	ANDA	16 sections