Drug information for ADVIL COLD AND SINUS

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL EQ 200MG FREE ACID AND POTASSIUM SALT;30MG Over The Counter  (Reference Drug) IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE Ibuprofen WYETH CONS 21374
2011-03-16 Letter

2009-05-27 Letter

2008-06-24 Letter

2006-04-20 Letter

2005-12-15 Letter

2004-05-26 Review

2003-10-22 Letter

2003-10-22 Label

2002-05-30 Letter

2002-05-30 Label
TABLET; ORAL 200MG;30MG Over The Counter  (Reference Drug) IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE Ibuprofen WYETH CONS 19771
2010-09-07 Letter

2009-05-26 Letter

2008-06-23 Letter

2006-04-20 Letter

2006-03-01 Letter

2003-10-22 Letter

2003-06-10 Label

Drug Adverse Effects information for ADVIL COLD AND SINUS

Role code Indications Reaction # Reports
PS COUGH DRUG INEFFECTIVE 1
PS EYE DISCHARGE ABDOMINAL DISCOMFORT 2
PS EYE DISCHARGE DRUG INEFFECTIVE 2
PS EYE DISCHARGE INCORRECT DOSE ADMINISTERED 2
PS EYE DISCHARGE TREMOR 2
PS HEADACHE DRUG INEFFECTIVE 1
PS HEADACHE FEELING JITTERY 1
PS HEADACHE SOMNOLENCE 1
PS NASAL CONGESTION ANXIETY 1
PS NASAL CONGESTION DIZZINESS 1
PS NASAL CONGESTION DYSPNOEA 1
PS NASAL CONGESTION HEADACHE 1
PS NASAL CONGESTION HYPERSENSITIVITY 1
PS NASAL CONGESTION INFLUENZA 1
PS NASAL CONGESTION NASOPHARYNGITIS 1
PS NASAL CONGESTION NERVOUSNESS 1
PS NASAL CONGESTION SKIN DISORDER 1
PS NASOPHARYNGITIS DRUG INEFFECTIVE 3
PS NASOPHARYNGITIS DYSPNOEA 1
PS NASOPHARYNGITIS HYPERSENSITIVITY 1
PS NASOPHARYNGITIS INSOMNIA 1
PS NASOPHARYNGITIS PALPITATIONS 1
PS NASOPHARYNGITIS SENSITIVITY OF TEETH 1
PS NASOPHARYNGITIS SKIN DISORDER 1
PS NASOPHARYNGITIS URTICARIA 1
PS PYREXIA ABDOMINAL DISCOMFORT 2
PS PYREXIA DRUG INEFFECTIVE 2
PS PYREXIA INCORRECT DOSE ADMINISTERED 2
PS PYREXIA TREMOR 2
PS RHINORRHOEA ABDOMINAL DISCOMFORT 2
PS RHINORRHOEA DRUG INEFFECTIVE 3
PS RHINORRHOEA INCORRECT DOSE ADMINISTERED 2
PS RHINORRHOEA TREMOR 2
PS SINUS CONGESTION DRUG INEFFECTIVE 1
PS SINUS DISORDER DRUG INEFFECTIVE 1
PS SINUS DISORDER URTICARIA 1
PS SINUSITIS ANXIETY 1
PS SINUSITIS DIZZINESS 1
PS SINUSITIS DYSPNOEA 1
PS SINUSITIS HEADACHE 1
PS SINUSITIS INFLUENZA 1
PS SINUSITIS NASOPHARYNGITIS 1
PS SINUSITIS NERVOUSNESS 1
PS SNEEZING DRUG INEFFECTIVE 1
SS BACK PAIN BLOOD CHOLESTEROL INCREASED 1
SS BACK PAIN HYPERSENSITIVITY 1
SS BACK PAIN RASH GENERALISED 1
SS BACK PAIN RASH MORBILLIFORM 1
SS BACK PAIN SINUSITIS 1
SS BACK PAIN URTICARIA 1
SS BLOOD CHOLESTEROL INCREASED BLOOD CHOLESTEROL INCREASED 1
SS BLOOD CHOLESTEROL INCREASED HYPERSENSITIVITY 1
SS BLOOD CHOLESTEROL INCREASED RASH GENERALISED 1
SS BLOOD CHOLESTEROL INCREASED RASH MORBILLIFORM 1
SS BLOOD CHOLESTEROL INCREASED SINUSITIS 1
SS BLOOD CHOLESTEROL INCREASED URTICARIA 1
SS COUGH DRUG INEFFECTIVE 5
SS EYE DISCHARGE ABDOMINAL DISCOMFORT 4
SS EYE DISCHARGE DRUG INEFFECTIVE 4
SS EYE DISCHARGE INCORRECT DOSE ADMINISTERED 4
SS EYE DISCHARGE TREMOR 4
SS HEADACHE DRUG INEFFECTIVE 5
SS NASAL CONGESTION ANXIETY 1
SS NASAL CONGESTION DIZZINESS 1
SS NASAL CONGESTION DYSPNOEA 1
SS NASAL CONGESTION HEADACHE 1
SS NASAL CONGESTION HYPERSENSITIVITY 1
SS NASAL CONGESTION INFLUENZA 1
SS NASAL CONGESTION NASOPHARYNGITIS 1
SS NASAL CONGESTION NERVOUSNESS 1
SS NASAL CONGESTION SKIN DISORDER 1
SS NASOPHARYNGITIS DRUG INEFFECTIVE 6
SS NASOPHARYNGITIS HYPERSENSITIVITY 1
SS NASOPHARYNGITIS SENSITIVITY OF TEETH 1
SS NASOPHARYNGITIS SKIN DISORDER 1
SS NASOPHARYNGITIS URTICARIA 1
SS PYREXIA ABDOMINAL DISCOMFORT 4
SS PYREXIA DRUG INEFFECTIVE 4
SS PYREXIA INCORRECT DOSE ADMINISTERED 4
SS PYREXIA TREMOR 4
SS RHINORRHOEA ABDOMINAL DISCOMFORT 4
SS RHINORRHOEA DRUG INEFFECTIVE 9
SS RHINORRHOEA INCORRECT DOSE ADMINISTERED 4
SS RHINORRHOEA TREMOR 4
SS SINUS CONGESTION DRUG INEFFECTIVE 5
SS SINUS DISORDER DRUG INEFFECTIVE 1
SS SINUS DISORDER URTICARIA 1
SS SINUSITIS ANXIETY 1
SS SINUSITIS BLOOD CHOLESTEROL INCREASED 3
SS SINUSITIS DIZZINESS 1
SS SINUSITIS DYSPNOEA 1
SS SINUSITIS HEADACHE 1
SS SINUSITIS HYPERSENSITIVITY 3
SS SINUSITIS INFLUENZA 1
SS SINUSITIS NASOPHARYNGITIS 1
SS SINUSITIS NERVOUSNESS 1
SS SINUSITIS RASH GENERALISED 3
SS SINUSITIS RASH MORBILLIFORM 3
SS SINUSITIS SINUSITIS 3
SS SINUSITIS URTICARIA 3
SS SNEEZING DRUG INEFFECTIVE 5
C CONTRACEPTION CHEST PAIN 2
C CONTRACEPTION DEEP VEIN THROMBOSIS 2
C CONTRACEPTION DYSPNOEA 2
C CONTRACEPTION PULMONARY EMBOLISM 2
C CONTRACEPTION PULMONARY INFARCTION 2
C MENSTRUAL CYCLE MANAGEMENT CHEST PAIN 2
C MENSTRUAL CYCLE MANAGEMENT DEEP VEIN THROMBOSIS 2
C MENSTRUAL CYCLE MANAGEMENT DYSPNOEA 2
C MENSTRUAL CYCLE MANAGEMENT PULMONARY EMBOLISM 2
C MENSTRUAL CYCLE MANAGEMENT PULMONARY INFARCTION 2
C NASAL CONGESTION CHEST PAIN 2
C NASAL CONGESTION DEEP VEIN THROMBOSIS 2
C NASAL CONGESTION DYSPNOEA 2
C NASAL CONGESTION PULMONARY EMBOLISM 2
C NASAL CONGESTION PULMONARY INFARCTION 2
C NASOPHARYNGITIS CHEST PAIN 2
C NASOPHARYNGITIS DEEP VEIN THROMBOSIS 2
C NASOPHARYNGITIS DYSPNOEA 2
C NASOPHARYNGITIS PULMONARY EMBOLISM 2
C NASOPHARYNGITIS PULMONARY INFARCTION 2
C ORAL CONTRACEPTION CHEST PAIN 2
C ORAL CONTRACEPTION DEEP VEIN THROMBOSIS 2
C ORAL CONTRACEPTION DYSPNOEA 2
C ORAL CONTRACEPTION PULMONARY EMBOLISM 2
C ORAL CONTRACEPTION PULMONARY INFARCTION 2
C RHEUMATOID ARTHRITIS PARAESTHESIA 1
C SINUSITIS CHEST PAIN 2
C SINUSITIS DEEP VEIN THROMBOSIS 2
C SINUSITIS DYSPNOEA 2
C SINUSITIS PULMONARY EMBOLISM 2
C SINUSITIS PULMONARY INFARCTION 2
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