Drug information for SUDAFED 24 HOUR

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET, EXTENDED RELEASE; ORAL	240MG	Over The Counter	(Reference Drug)	PSEUDOEPHEDRINE HYDROCHLORIDE	Ephedrine	MCNEIL CONS	20021 2007-07-06 Review 2007-07-06 Review 2007-07-06 Review 2007-05-09 Review 2007-05-09 Review 2007-05-09 Review

Drug Adverse Effects information for SUDAFED 24 HOUR

Role code	Indications	Reaction	# Reports
PS	ACCIDENTAL OVERDOSE	ACCIDENTAL OVERDOSE	1
PS	ACCIDENTAL OVERDOSE	MEDICATION ERROR	1
PS	ACCIDENTAL OVERDOSE	SOMNOLENCE	1
PS	ILL-DEFINED DISORDER	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	1
PS	ILL-DEFINED DISORDER	OVERDOSE	1
PS	NASAL CONGESTION	ARRHYTHMIA SUPRAVENTRICULAR	1
PS	NASAL CONGESTION	ASTHENIA	3
PS	NASAL CONGESTION	BLOOD PRESSURE DECREASED	1
PS	NASAL CONGESTION	DEHYDRATION	1
PS	NASAL CONGESTION	DIZZINESS	4
PS	NASAL CONGESTION	DYSGEUSIA	1
PS	NASAL CONGESTION	HEART RATE INCREASED	1
PS	NASAL CONGESTION	LOSS OF CONSCIOUSNESS	1
PS	NASAL CONGESTION	NAUSEA	2
PS	NASAL CONGESTION	OVERDOSE	3
PS	NASAL CONGESTION	SOMNOLENCE	1
PS	NASOPHARYNGITIS	CHEST PAIN	2
PS	NASOPHARYNGITIS	FEELING ABNORMAL	2
PS	NASOPHARYNGITIS	HEART RATE INCREASED	2
PS	NASOPHARYNGITIS	INCORRECT DOSE ADMINISTERED	1
PS	NASOPHARYNGITIS	INSOMNIA	2
PS	NASOPHARYNGITIS	NO ADVERSE EVENT	1
PS	NASOPHARYNGITIS	OVERDOSE	1
PS	PRENATAL CARE	FOETAL EXPOSURE DURING PREGNANCY	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	APNOEA	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	BRAIN DEATH	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	BRAIN OEDEMA	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	CARDIAC ARREST	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	CHEST PAIN	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	COMPLETED SUICIDE	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	FEELING ABNORMAL	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	FOETAL EXPOSURE DURING PREGNANCY	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	HEART RATE INCREASED	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	INSOMNIA	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	LETHARGY	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	MYDRIASIS	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	OVERDOSE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PUPIL FIXED	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	RESPIRATORY DISORDER	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	VOMITING	3
PS	RESPIRATORY DISORDER	ARRHYTHMIA SUPRAVENTRICULAR	1
PS	RESPIRATORY DISORDER	ASTHENIA	1
PS	RESPIRATORY DISORDER	BLOOD PRESSURE DECREASED	1
PS	RESPIRATORY DISORDER	DEHYDRATION	1
PS	RESPIRATORY DISORDER	DIZZINESS	1
PS	RESPIRATORY DISORDER	HEART RATE INCREASED	1
PS	RESPIRATORY DISORDER	LOSS OF CONSCIOUSNESS	1
PS	RESPIRATORY DISORDER	NAUSEA	1
PS	RESPIRATORY DISORDER	SOMNOLENCE	1
SS	ACCIDENTAL OVERDOSE	ACCIDENTAL OVERDOSE	1
SS	ACCIDENTAL OVERDOSE	MEDICATION ERROR	1
SS	ACCIDENTAL OVERDOSE	SOMNOLENCE	1
SS	ILL-DEFINED DISORDER	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	1
SS	ILL-DEFINED DISORDER	OVERDOSE	1
SS	NASAL CONGESTION	ARRHYTHMIA SUPRAVENTRICULAR	1
SS	NASAL CONGESTION	ASTHENIA	3
SS	NASAL CONGESTION	BLOOD PRESSURE DECREASED	1
SS	NASAL CONGESTION	DEHYDRATION	1
SS	NASAL CONGESTION	DIZZINESS	4
SS	NASAL CONGESTION	DYSGEUSIA	1
SS	NASAL CONGESTION	HEART RATE INCREASED	1
SS	NASAL CONGESTION	LOSS OF CONSCIOUSNESS	1
SS	NASAL CONGESTION	NAUSEA	2
SS	NASAL CONGESTION	OVERDOSE	3
SS	NASAL CONGESTION	SOMNOLENCE	1
SS	NASOPHARYNGITIS	CHEST PAIN	2
SS	NASOPHARYNGITIS	FEELING ABNORMAL	2
SS	NASOPHARYNGITIS	HEART RATE INCREASED	2
SS	NASOPHARYNGITIS	INCORRECT DOSE ADMINISTERED	1
SS	NASOPHARYNGITIS	INSOMNIA	2
SS	NASOPHARYNGITIS	NO ADVERSE EVENT	1
SS	NASOPHARYNGITIS	OVERDOSE	1
SS	PRENATAL CARE	FOETAL EXPOSURE DURING PREGNANCY	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	APNOEA	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	BRAIN DEATH	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	BRAIN OEDEMA	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	CARDIAC ARREST	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	CHEST PAIN	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	COMPLETED SUICIDE	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	FEELING ABNORMAL	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	FOETAL EXPOSURE DURING PREGNANCY	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	HEART RATE INCREASED	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	INCORRECT DRUG ADMINISTRATION DURATION	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	INSOMNIA	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	LETHARGY	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	MYDRIASIS	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	OVERDOSE	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	PUPIL FIXED	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	RESPIRATORY DISORDER	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	VOMITING	3
SS	RESPIRATORY DISORDER	ARRHYTHMIA SUPRAVENTRICULAR	1
SS	RESPIRATORY DISORDER	ASTHENIA	1
SS	RESPIRATORY DISORDER	BLOOD PRESSURE DECREASED	1
SS	RESPIRATORY DISORDER	DEHYDRATION	1
SS	RESPIRATORY DISORDER	DIZZINESS	1
SS	RESPIRATORY DISORDER	HEART RATE INCREASED	1
SS	RESPIRATORY DISORDER	LOSS OF CONSCIOUSNESS	1
SS	RESPIRATORY DISORDER	NAUSEA	1
SS	RESPIRATORY DISORDER	SOMNOLENCE	1

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