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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