Drug information for ZYRTEC-D 12 HOUR

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET, EXTENDED RELEASE; ORAL	5MG;120MG	Over The Counter	(Reference Drug)	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	Cetirizine	MCNEIL	21150 2008-05-21 Review 2007-11-13 Letter 2004-04-05 Label 2004-03-24 Letter 2003-05-29 Letter 2003-04-17 Label 2001-08-10 Letter 2001-08-10 Label 2001-08-10 Review

Drug Adverse Effects information for ZYRTEC-D 12 HOUR

Role code	Indications	Reaction	# Reports
PS	HYPERSENSITIVITY	BLOOD GLUCOSE INCREASED	2
PS	HYPERSENSITIVITY	DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE	2
PS	HYPERSENSITIVITY	EXPIRED DRUG ADMINISTERED	2
PS	MULTIPLE ALLERGIES	ABDOMINAL DISCOMFORT	2
PS	MULTIPLE ALLERGIES	ABDOMINAL PAIN UPPER	2
PS	MULTIPLE ALLERGIES	ANXIETY	2
PS	MULTIPLE ALLERGIES	DIARRHOEA	2
PS	MULTIPLE ALLERGIES	MALAISE	2
PS	MULTIPLE ALLERGIES	NAUSEA	2
PS	MULTIPLE ALLERGIES	OFF LABEL USE	2
PS	MULTIPLE ALLERGIES	OVERDOSE	2
PS	MULTIPLE ALLERGIES	THYROID DISORDER	2
PS	NASOPHARYNGITIS	BLOOD GLUCOSE INCREASED	2
PS	NASOPHARYNGITIS	DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE	2
PS	NASOPHARYNGITIS	EXPIRED DRUG ADMINISTERED	2
PS	SINUS CONGESTION	ABDOMINAL DISCOMFORT	2
PS	SINUS CONGESTION	ABDOMINAL PAIN UPPER	2
PS	SINUS CONGESTION	ANXIETY	2
PS	SINUS CONGESTION	DIARRHOEA	2
PS	SINUS CONGESTION	MALAISE	2
PS	SINUS CONGESTION	NAUSEA	2
PS	SINUS CONGESTION	OFF LABEL USE	2
PS	SINUS CONGESTION	OVERDOSE	2
PS	SINUS CONGESTION	THYROID DISORDER	2
PS	SINUSITIS	ABDOMINAL DISCOMFORT	4
PS	SINUSITIS	ABDOMINAL PAIN UPPER	4
PS	SINUSITIS	ANXIETY	4
PS	SINUSITIS	DIARRHOEA	4
PS	SINUSITIS	MALAISE	4
PS	SINUSITIS	NAUSEA	4
PS	SINUSITIS	OFF LABEL USE	4
PS	SINUSITIS	OVERDOSE	4
PS	SINUSITIS	THYROID DISORDER	4
SS	HYPERSENSITIVITY	BLOOD GLUCOSE INCREASED	2
SS	HYPERSENSITIVITY	DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE	2
SS	HYPERSENSITIVITY	EXPIRED DRUG ADMINISTERED	2
SS	MULTIPLE ALLERGIES	ABDOMINAL DISCOMFORT	10
SS	MULTIPLE ALLERGIES	ABDOMINAL PAIN UPPER	10
SS	MULTIPLE ALLERGIES	ANXIETY	10
SS	MULTIPLE ALLERGIES	BLOOD PRESSURE INCREASED	2
SS	MULTIPLE ALLERGIES	DIARRHOEA	10
SS	MULTIPLE ALLERGIES	DRY MOUTH	2
SS	MULTIPLE ALLERGIES	HYPERSENSITIVITY	2
SS	MULTIPLE ALLERGIES	INSOMNIA	2
SS	MULTIPLE ALLERGIES	MALAISE	10
SS	MULTIPLE ALLERGIES	NAUSEA	10
SS	MULTIPLE ALLERGIES	OFF LABEL USE	10
SS	MULTIPLE ALLERGIES	OVERDOSE	10
SS	MULTIPLE ALLERGIES	THYROID DISORDER	10
SS	MULTIPLE ALLERGIES	VAGINAL HAEMORRHAGE	2
SS	NASOPHARYNGITIS	BLOOD GLUCOSE INCREASED	2
SS	NASOPHARYNGITIS	DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE	2
SS	NASOPHARYNGITIS	EXPIRED DRUG ADMINISTERED	2
SS	SINUS CONGESTION	ABDOMINAL DISCOMFORT	10
SS	SINUS CONGESTION	ABDOMINAL PAIN UPPER	10
SS	SINUS CONGESTION	ANXIETY	10
SS	SINUS CONGESTION	DIARRHOEA	10
SS	SINUS CONGESTION	MALAISE	10
SS	SINUS CONGESTION	NAUSEA	10
SS	SINUS CONGESTION	OFF LABEL USE	10
SS	SINUS CONGESTION	OVERDOSE	10
SS	SINUS CONGESTION	THYROID DISORDER	10
SS	SINUSITIS	ABDOMINAL DISCOMFORT	20
SS	SINUSITIS	ABDOMINAL PAIN UPPER	20
SS	SINUSITIS	ANXIETY	20
SS	SINUSITIS	DIARRHOEA	20
SS	SINUSITIS	MALAISE	20
SS	SINUSITIS	NAUSEA	20
SS	SINUSITIS	OFF LABEL USE	20
SS	SINUSITIS	OVERDOSE	20
SS	SINUSITIS	THYROID DISORDER	20
C	ARTHRITIS	CATARACT	1
C	ASTHMA	ANXIETY	1
C	ASTHMA	BRONCHOSPASM	6
C	ASTHMA	COLITIS ISCHAEMIC	1
C	ASTHMA	DYSPEPSIA	6
C	ASTHMA	EMOTIONAL DISTRESS	1
C	ASTHMA	FEAR	1
C	ASTHMA	FLUSHING	6
C	ASTHMA	HOT FLUSH	6
C	ASTHMA	INJURY	1
C	ASTHMA	NASAL CONGESTION	6
C	ASTHMA	PAIN	2
C	ASTHMA	PRURITUS	6
C	ASTHMA	PSYCHOLOGICAL TRAUMA	1
C	ASTHMA	SPLENIC INFARCTION	1
C	ASTHMA	THROMBOSIS	2
C	BLOOD OESTROGEN ABNORMAL	CATARACT	1
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	CATARACT	1
C	COLITIS ULCERATIVE	ABDOMINAL PAIN UPPER	2
C	COLITIS ULCERATIVE	COLITIS ULCERATIVE	2
C	COLITIS ULCERATIVE	DRUG INEFFECTIVE	2
C	COLITIS ULCERATIVE	EAR PAIN	2
C	COLITIS ULCERATIVE	EATING DISORDER	2
C	COLITIS ULCERATIVE	HEADACHE	2
C	COLITIS ULCERATIVE	MALAISE	2
C	COLITIS ULCERATIVE	NAUSEA	2
C	COLITIS ULCERATIVE	OTITIS MEDIA	2
C	COLITIS ULCERATIVE	PAIN IN JAW	2
C	COLITIS ULCERATIVE	SWELLING	2
C	COLITIS ULCERATIVE	URTICARIA	2
C	CONSTIPATION	CATARACT	1
C	CONTRACEPTION	ANXIETY	1
C	CONTRACEPTION	BACK PAIN	1
C	CONTRACEPTION	CHOLECYSTITIS ACUTE	1
C	CONTRACEPTION	CHOLELITHIASIS	1
C	CONTRACEPTION	COLITIS ISCHAEMIC	1
C	CONTRACEPTION	DEEP VEIN THROMBOSIS	1
C	CONTRACEPTION	EFFUSION	1
C	CONTRACEPTION	EMOTIONAL DISTRESS	1
C	CONTRACEPTION	FEAR	1
C	CONTRACEPTION	INJURY	1
C	CONTRACEPTION	LEUKOCYTOSIS	1
C	CONTRACEPTION	MUSCULOSKELETAL CHEST PAIN	1
C	CONTRACEPTION	PAIN	1
C	CONTRACEPTION	PAIN IN EXTREMITY	1
C	CONTRACEPTION	PNEUMONIA	1
C	CONTRACEPTION	PSYCHOLOGICAL TRAUMA	1
C	CONTRACEPTION	PULMONARY EMBOLISM	2
C	CONTRACEPTION	PULMONARY FIBROSIS	1
C	CONTRACEPTION	THROMBOSIS	1
C	DEPRESSION	CATARACT	1
C	DEPRESSION	CHOLECYSTITIS ACUTE	1
C	DEPRESSION	CHOLELITHIASIS	1
C	DEPRESSION	EFFUSION	1
C	DEPRESSION	LEUKOCYTOSIS	1
C	DEPRESSION	PNEUMONIA	1
C	DEPRESSION	PULMONARY EMBOLISM	1
C	DYSMENORRHOEA	BACK PAIN	1
C	DYSMENORRHOEA	DEEP VEIN THROMBOSIS	1
C	DYSMENORRHOEA	MUSCULOSKELETAL CHEST PAIN	1
C	DYSMENORRHOEA	PAIN IN EXTREMITY	1
C	DYSMENORRHOEA	PULMONARY EMBOLISM	1
C	DYSMENORRHOEA	PULMONARY FIBROSIS	1
C	DYSPEPSIA	CATARACT	1
C	HEART RATE IRREGULAR	ABDOMINAL DISCOMFORT	1
C	HEART RATE IRREGULAR	ABDOMINAL PAIN UPPER	1
C	HEART RATE IRREGULAR	ADDISON'S DISEASE	1
C	HEART RATE IRREGULAR	ANAEMIA	1
C	HEART RATE IRREGULAR	ANHEDONIA	1
C	HEART RATE IRREGULAR	ANXIETY	1
C	HEART RATE IRREGULAR	APHAGIA	1
C	HEART RATE IRREGULAR	ASTHENIA	1
C	HEART RATE IRREGULAR	BALANCE DISORDER	1
C	HEART RATE IRREGULAR	BLOOD BILIRUBIN INCREASED	1
C	HEART RATE IRREGULAR	BLOOD GLUCOSE FLUCTUATION	1
C	HEART RATE IRREGULAR	BLOOD GLUCOSE INCREASED	1
C	HEART RATE IRREGULAR	BLOOD PRESSURE INCREASED	1
C	HEART RATE IRREGULAR	CHEST DISCOMFORT	1
C	HEART RATE IRREGULAR	CHOLELITHIASIS	1
C	HEART RATE IRREGULAR	DECREASED APPETITE	1
C	HEART RATE IRREGULAR	DEHYDRATION	1
C	HEART RATE IRREGULAR	DIARRHOEA	1
C	HEART RATE IRREGULAR	ECONOMIC PROBLEM	1
C	HEART RATE IRREGULAR	EJECTION FRACTION DECREASED	1
C	HEART RATE IRREGULAR	ELECTROCARDIOGRAM ST SEGMENT ABNORMAL	1
C	HEART RATE IRREGULAR	ELECTROCARDIOGRAM ST-T CHANGE	1
C	HEART RATE IRREGULAR	EMOTIONAL DISORDER	1
C	HEART RATE IRREGULAR	ERUCTATION	1
C	HEART RATE IRREGULAR	FATIGUE	1
C	HEART RATE IRREGULAR	GASTRODUODENITIS	1
C	HEART RATE IRREGULAR	GLOMERULAR FILTRATION RATE DECREASED	1
C	HEART RATE IRREGULAR	HEART RATE INCREASED	1
C	HEART RATE IRREGULAR	HYPERKALAEMIA	1
C	HEART RATE IRREGULAR	HYPOMAGNESAEMIA	1
C	HEART RATE IRREGULAR	HYPONATRAEMIA	1
C	HEART RATE IRREGULAR	LARYNGITIS	1
C	HEART RATE IRREGULAR	MENTAL DISORDER	1
C	HEART RATE IRREGULAR	MITRAL VALVE INCOMPETENCE	1
C	HEART RATE IRREGULAR	MULTIPLE INJURIES	1
C	HEART RATE IRREGULAR	MYOCARDIAL ISCHAEMIA	1
C	HEART RATE IRREGULAR	NAUSEA	1
C	HEART RATE IRREGULAR	NOCTURIA	1
C	HEART RATE IRREGULAR	OROPHARYNGEAL PAIN	1
C	HEART RATE IRREGULAR	PAIN	1
C	HEART RATE IRREGULAR	PALPITATIONS	1
C	HEART RATE IRREGULAR	PULMONARY HYPERTENSION	1
C	HEART RATE IRREGULAR	PULMONARY VALVE INCOMPETENCE	1
C	HEART RATE IRREGULAR	RENAL CYST	1
C	HEART RATE IRREGULAR	SINUS TACHYCARDIA	1
C	HEART RATE IRREGULAR	TOXICITY TO VARIOUS AGENTS	1
C	HEART RATE IRREGULAR	TRICUSPID VALVE INCOMPETENCE	1
C	HEART RATE IRREGULAR	URINARY TRACT INFECTION	1
C	HEART RATE IRREGULAR	VERTIGO	1
C	HEART RATE IRREGULAR	VIRAL INFECTION	1
C	HEART RATE IRREGULAR	WEIGHT DECREASED	1
C	MENSTRUATION IRREGULAR	ABDOMINAL PAIN	6
C	MENSTRUATION IRREGULAR	ANXIETY	6
C	MENSTRUATION IRREGULAR	BILIARY DYSKINESIA	6
C	MENSTRUATION IRREGULAR	CHOLECYSTITIS CHRONIC	6
C	MENSTRUATION IRREGULAR	CHOLELITHIASIS	6
C	MENSTRUATION IRREGULAR	DISCOMFORT	6
C	MENSTRUATION IRREGULAR	EMOTIONAL DISTRESS	6
C	MENSTRUATION IRREGULAR	FEAR	6
C	MENSTRUATION IRREGULAR	GALLBLADDER DISORDER	6
C	MENSTRUATION IRREGULAR	INJURY	6
C	MENSTRUATION IRREGULAR	PAIN	6
C	MULTIPLE ALLERGIES	CHOLECYSTITIS ACUTE	1
C	MULTIPLE ALLERGIES	CHOLELITHIASIS	1
C	MULTIPLE ALLERGIES	EFFUSION	1
C	MULTIPLE ALLERGIES	LEUKOCYTOSIS	1
C	MULTIPLE ALLERGIES	PNEUMONIA	1
C	MULTIPLE ALLERGIES	PULMONARY EMBOLISM	1
C	MULTIPLE MYELOMA	SOFT TISSUE INFECTION	3
C	MULTIPLE SCLEROSIS	CHOLECYSTITIS ACUTE	2
C	MULTIPLE SCLEROSIS	CHOLELITHIASIS	2
C	MULTIPLE SCLEROSIS	EFFUSION	2
C	MULTIPLE SCLEROSIS	LEUKOCYTOSIS	2
C	MULTIPLE SCLEROSIS	PNEUMONIA	2
C	MULTIPLE SCLEROSIS	PULMONARY EMBOLISM	2
C	MUSCLE RELAXANT THERAPY	BACK PAIN	1
C	MUSCLE RELAXANT THERAPY	DEEP VEIN THROMBOSIS	1
C	MUSCLE RELAXANT THERAPY	MUSCULOSKELETAL CHEST PAIN	1
C	MUSCLE RELAXANT THERAPY	PAIN IN EXTREMITY	1
C	MUSCLE RELAXANT THERAPY	PULMONARY EMBOLISM	1
C	MUSCLE RELAXANT THERAPY	PULMONARY FIBROSIS	1
C	ORAL CONTRACEPTION	CHOLECYSTITIS CHRONIC	1
C	ORAL CONTRACEPTION	GALLBLADDER NON-FUNCTIONING	1
C	PAIN	CATARACT	2
C	PRODUCT USED FOR UNKNOWN INDICATION	ABDOMINAL PAIN UPPER	1
C	PRODUCT USED FOR UNKNOWN INDICATION	CHOLECYSTITIS ACUTE	9
C	PRODUCT USED FOR UNKNOWN INDICATION	CHOLELITHIASIS	9
C	PRODUCT USED FOR UNKNOWN INDICATION	COLITIS ULCERATIVE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	DRUG INEFFECTIVE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	EAR PAIN	1
C	PRODUCT USED FOR UNKNOWN INDICATION	EATING DISORDER	1
C	PRODUCT USED FOR UNKNOWN INDICATION	EFFUSION	9
C	PRODUCT USED FOR UNKNOWN INDICATION	HEADACHE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	LEUKOCYTOSIS	9
C	PRODUCT USED FOR UNKNOWN INDICATION	MALAISE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	NAUSEA	1
C	PRODUCT USED FOR UNKNOWN INDICATION	OTITIS MEDIA	1
C	PRODUCT USED FOR UNKNOWN INDICATION	PAIN IN JAW	1
C	PRODUCT USED FOR UNKNOWN INDICATION	PNEUMONIA	9
C	PRODUCT USED FOR UNKNOWN INDICATION	PULMONARY EMBOLISM	9
C	PRODUCT USED FOR UNKNOWN INDICATION	SOFT TISSUE INFECTION	19
C	PRODUCT USED FOR UNKNOWN INDICATION	SWELLING	1
C	PRODUCT USED FOR UNKNOWN INDICATION	URTICARIA	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	ARTHRALGIA	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	CHILLS	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	DIARRHOEA	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	URINARY TRACT INFECTION	1
C	RELAPSING-REMITTING MULTIPLE SCLEROSIS	VOMITING	1
C	RHEUMATOID ARTHRITIS	ABDOMINAL DISCOMFORT	1
C	RHEUMATOID ARTHRITIS	DIZZINESS	1
C	RHEUMATOID ARTHRITIS	ERYTHEMA	1
C	RHEUMATOID ARTHRITIS	FATIGUE	1
C	RHEUMATOID ARTHRITIS	INSOMNIA	1
C	RHEUMATOID ARTHRITIS	NAUSEA	1
C	RHEUMATOID ARTHRITIS	PRURITUS	1
C	RHEUMATOID ARTHRITIS	RHEUMATOID ARTHRITIS	1
C	RHEUMATOID ARTHRITIS	URTICARIA	1
C	RHINITIS ALLERGIC	BRONCHOSPASM	1
C	RHINITIS ALLERGIC	DYSPEPSIA	1
C	RHINITIS ALLERGIC	FLUSHING	1
C	RHINITIS ALLERGIC	HOT FLUSH	1
C	RHINITIS ALLERGIC	NASAL CONGESTION	1
C	RHINITIS ALLERGIC	PRURITUS	1
C	SEASONAL ALLERGY	ABDOMINAL PAIN UPPER	1
C	SEASONAL ALLERGY	CATARACT	1
C	SEASONAL ALLERGY	COLITIS ULCERATIVE	1
C	SEASONAL ALLERGY	DRUG INEFFECTIVE	1
C	SEASONAL ALLERGY	EAR PAIN	1
C	SEASONAL ALLERGY	EATING DISORDER	1
C	SEASONAL ALLERGY	HEADACHE	1
C	SEASONAL ALLERGY	MALAISE	1
C	SEASONAL ALLERGY	NAUSEA	1
C	SEASONAL ALLERGY	OTITIS MEDIA	1
C	SEASONAL ALLERGY	PAIN IN JAW	1
C	SEASONAL ALLERGY	SWELLING	1
C	SEASONAL ALLERGY	URTICARIA	1
C	SINUS DISORDER	ANXIETY	1
C	SINUS DISORDER	COLITIS ISCHAEMIC	1
C	SINUS DISORDER	EMOTIONAL DISTRESS	1
C	SINUS DISORDER	FEAR	1
C	SINUS DISORDER	INJURY	1
C	SINUS DISORDER	PAIN	1
C	SINUS DISORDER	PSYCHOLOGICAL TRAUMA	1
C	SINUS DISORDER	THROMBOSIS	1
C	SUPPLEMENTATION THERAPY	CATARACT	1

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