Drug information for ADVIL CONGESTION RELIEF

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET; ORAL	200MG;10MG	Over The Counter	(Reference Drug)	IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	Ibuprofen	WYETH CONS	22565 2010-09-23 Review 2010-09-23 Summary Review 2010-06-03 Letter

Drug Adverse Effects information for ADVIL CONGESTION RELIEF

Role code	Indications	Reaction	# Reports
PS	ABDOMINAL DISCOMFORT	DRUG INEFFECTIVE	1
PS	ARTHRITIS	DRUG INEFFECTIVE	1
PS	BACK DISORDER	ABDOMINAL PAIN UPPER	4
PS	BACK PAIN	DRUG INEFFECTIVE	1
PS	BLOOD CHOLESTEROL INCREASED	DRUG INEFFECTIVE	1
PS	BLOOD CHOLESTEROL INCREASED	INSOMNIA	1
PS	BLOOD CHOLESTEROL INCREASED	NAUSEA	1
PS	COUGH	ACTIVITIES OF DAILY LIVING IMPAIRED	1
PS	COUGH	CHEST PAIN	1
PS	COUGH	DRUG INEFFECTIVE	1
PS	COUGH	DYSPNOEA	1
PS	COUGH	EYE PRURITUS	1
PS	COUGH	FEELING ABNORMAL	1
PS	COUGH	PRURITUS	1
PS	COUGH	RASH ERYTHEMATOUS	1
PS	COUGH	RASH MACULAR	1
PS	COUGH	TREMOR	1
PS	COUGH	WHEEZING	1
PS	HEADACHE	ABDOMINAL PAIN UPPER	2
PS	HEADACHE	ACTIVITIES OF DAILY LIVING IMPAIRED	1
PS	HEADACHE	CHEST PAIN	1
PS	HEADACHE	DRUG INEFFECTIVE	3
PS	HEADACHE	DYSPNOEA	1
PS	HEADACHE	EYE PRURITUS	1
PS	HEADACHE	FEELING ABNORMAL	1
PS	HEADACHE	INSOMNIA	2
PS	HEADACHE	NAUSEA	2
PS	HEADACHE	PRURITUS	1
PS	HEADACHE	RASH ERYTHEMATOUS	1
PS	HEADACHE	RASH MACULAR	1
PS	HEADACHE	TREMOR	1
PS	HEADACHE	WHEEZING	1
PS	HYPERTENSION	DRUG INEFFECTIVE	1
PS	INFLUENZA	DRUG INEFFECTIVE	1
PS	MALAISE	DRUG INEFFECTIVE	1
PS	MUSCLE RELAXANT THERAPY	ABDOMINAL PAIN UPPER	2
PS	NASAL CONGESTION	ACTIVITIES OF DAILY LIVING IMPAIRED	1
PS	NASAL CONGESTION	CHEST PAIN	1
PS	NASAL CONGESTION	COUGH	1
PS	NASAL CONGESTION	DIZZINESS	1
PS	NASAL CONGESTION	DRUG INEFFECTIVE	4
PS	NASAL CONGESTION	DYSPNOEA	1
PS	NASAL CONGESTION	EYE PRURITUS	1
PS	NASAL CONGESTION	FEELING ABNORMAL	1
PS	NASAL CONGESTION	LOSS OF CONSCIOUSNESS	1
PS	NASAL CONGESTION	NASAL CONGESTION	1
PS	NASAL CONGESTION	PRURITUS	1
PS	NASAL CONGESTION	RASH ERYTHEMATOUS	1
PS	NASAL CONGESTION	RASH MACULAR	1
PS	NASAL CONGESTION	RESPIRATION ABNORMAL	1
PS	NASAL CONGESTION	SINUS DISORDER	1
PS	NASAL CONGESTION	SOMNOLENCE	2
PS	NASAL CONGESTION	TREMOR	1
PS	NASAL CONGESTION	WHEEZING	1
PS	NASAL DISORDER	LOSS OF CONSCIOUSNESS	1
PS	NASAL DISORDER	SINUS DISORDER	1
PS	NASAL DISORDER	SOMNOLENCE	1
PS	NASOPHARYNGITIS	DRUG INEFFECTIVE	5
PS	RESPIRATORY TRACT CONGESTION	CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR	3
PS	RESPIRATORY TRACT CONGESTION	DECREASED APPETITE	3
PS	RESPIRATORY TRACT CONGESTION	DRUG INEFFECTIVE	1
PS	RESPIRATORY TRACT CONGESTION	DYSPNOEA	2
PS	RESPIRATORY TRACT CONGESTION	HYPERSENSITIVITY	1
PS	RESPIRATORY TRACT CONGESTION	MALAISE	3
PS	RESPIRATORY TRACT CONGESTION	NAUSEA	3
PS	RESPIRATORY TRACT CONGESTION	RESPIRATORY TRACT CONGESTION	1
PS	RESPIRATORY TRACT CONGESTION	THROAT TIGHTNESS	1
PS	RESPIRATORY TRACT CONGESTION	VOMITING	3
PS	SINUS CONGESTION	DRUG INEFFECTIVE	3
PS	SINUS CONGESTION	HEADACHE	1
PS	SINUS CONGESTION	INSOMNIA	2
PS	SINUS CONGESTION	NAUSEA	2
PS	SINUS CONGESTION	UPPER RESPIRATORY TRACT CONGESTION	1
PS	SINUS DISORDER	BLOOD PRESSURE INCREASED	2
PS	SINUS DISORDER	DRUG INEFFECTIVE	1
PS	SINUS DISORDER	LOSS OF CONSCIOUSNESS	1
PS	SINUS DISORDER	SINUS DISORDER	1
PS	SINUS DISORDER	SOMNOLENCE	1
PS	SINUS HEADACHE	DRUG INEFFECTIVE	3
PS	SINUS HEADACHE	INSOMNIA	2
PS	SINUS HEADACHE	NAUSEA	2
PS	SWELLING	DRUG INEFFECTIVE	1
PS	THYROID DISORDER	DRUG INEFFECTIVE	1
SS	BLOOD CHOLESTEROL INCREASED	DRUG INEFFECTIVE	2
SS	BLOOD CHOLESTEROL INCREASED	INSOMNIA	2
SS	BLOOD CHOLESTEROL INCREASED	NAUSEA	2
SS	COUGH	ACTIVITIES OF DAILY LIVING IMPAIRED	2
SS	COUGH	CHEST PAIN	2
SS	COUGH	DRUG INEFFECTIVE	1
SS	COUGH	DYSPNOEA	2
SS	COUGH	EYE PRURITUS	2
SS	COUGH	FEELING ABNORMAL	2
SS	COUGH	PRURITUS	2
SS	COUGH	RASH ERYTHEMATOUS	2
SS	COUGH	RASH MACULAR	2
SS	COUGH	TREMOR	2
SS	COUGH	WHEEZING	2
SS	HEADACHE	ACTIVITIES OF DAILY LIVING IMPAIRED	2
SS	HEADACHE	CHEST PAIN	2
SS	HEADACHE	DRUG INEFFECTIVE	6
SS	HEADACHE	DYSPNOEA	2
SS	HEADACHE	EYE PRURITUS	2
SS	HEADACHE	FATIGUE	2
SS	HEADACHE	FEELING ABNORMAL	2
SS	HEADACHE	HEADACHE	2
SS	HEADACHE	INSOMNIA	4
SS	HEADACHE	MUSCULOSKELETAL DISCOMFORT	2
SS	HEADACHE	NASAL CONGESTION	2
SS	HEADACHE	NASOPHARYNGITIS	2
SS	HEADACHE	NAUSEA	4
SS	HEADACHE	PRURITUS	2
SS	HEADACHE	RASH ERYTHEMATOUS	2
SS	HEADACHE	RASH MACULAR	2
SS	HEADACHE	TREMOR	2
SS	HEADACHE	WHEEZING	2
SS	MALAISE	DRUG INEFFECTIVE	2
SS	NASAL CONGESTION	ACTIVITIES OF DAILY LIVING IMPAIRED	2
SS	NASAL CONGESTION	CHEST PAIN	2
SS	NASAL CONGESTION	DRUG INEFFECTIVE	3
SS	NASAL CONGESTION	DYSPNOEA	2
SS	NASAL CONGESTION	EYE PRURITUS	2
SS	NASAL CONGESTION	FATIGUE	2
SS	NASAL CONGESTION	FEELING ABNORMAL	2
SS	NASAL CONGESTION	HEADACHE	2
SS	NASAL CONGESTION	LOSS OF CONSCIOUSNESS	2
SS	NASAL CONGESTION	MUSCULOSKELETAL DISCOMFORT	2
SS	NASAL CONGESTION	NASAL CONGESTION	2
SS	NASAL CONGESTION	NASOPHARYNGITIS	2
SS	NASAL CONGESTION	PRURITUS	2
SS	NASAL CONGESTION	RASH ERYTHEMATOUS	2
SS	NASAL CONGESTION	RASH MACULAR	2
SS	NASAL CONGESTION	SINUS DISORDER	2
SS	NASAL CONGESTION	SOMNOLENCE	2
SS	NASAL CONGESTION	TREMOR	2
SS	NASAL CONGESTION	WHEEZING	2
SS	NASAL DISORDER	LOSS OF CONSCIOUSNESS	2
SS	NASAL DISORDER	SINUS DISORDER	2
SS	NASAL DISORDER	SOMNOLENCE	2
SS	NASOPHARYNGITIS	FATIGUE	4
SS	NASOPHARYNGITIS	HEADACHE	4
SS	NASOPHARYNGITIS	MUSCULOSKELETAL DISCOMFORT	4
SS	NASOPHARYNGITIS	NASAL CONGESTION	4
SS	NASOPHARYNGITIS	NASOPHARYNGITIS	4
SS	PAIN	FATIGUE	2
SS	PAIN	HEADACHE	2
SS	PAIN	MUSCULOSKELETAL DISCOMFORT	2
SS	PAIN	NASAL CONGESTION	2
SS	PAIN	NASOPHARYNGITIS	2
SS	SINUS CONGESTION	DRUG INEFFECTIVE	4
SS	SINUS CONGESTION	INSOMNIA	4
SS	SINUS CONGESTION	NAUSEA	4
SS	SINUS DISORDER	LOSS OF CONSCIOUSNESS	2
SS	SINUS DISORDER	SINUS DISORDER	2
SS	SINUS DISORDER	SOMNOLENCE	2
SS	SINUS HEADACHE	DRUG INEFFECTIVE	4
SS	SINUS HEADACHE	INSOMNIA	4
SS	SINUS HEADACHE	NAUSEA	4
SS	SWELLING	DRUG INEFFECTIVE	1

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