Drug information for NICORETTE (MINT)

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
GUM, CHEWING; BUCCAL	EQ 2MG BASE	Over The Counter		NICOTINE POLACRILEX		GLAXOSMITHKLINE	18612 2012-03-28 Label 2012-03-27 Review 2012-02-17 Letter 2012-02-03 Letter 2011-09-29 Letter 2011-05-19 Letter 2009-05-08 Letter 2008-06-16 Letter 2007-07-06 Review 2007-07-05 Letter 2007-06-27 Label 2006-05-05 Letter 2005-12-13 Letter 2005-12-13 Label 2005-05-02 Review 2004-06-24 Letter 2004-06-23 Letter 2004-04-29 Letter 2002-08-09 Letter 1998-12-23 Review 1998-12-23 Label 1998-12-23 Letter
GUM, CHEWING; BUCCAL	EQ 4MG BASE	Over The Counter		NICOTINE POLACRILEX		GLAXOSMITHKLINE	20066 2012-03-28 Label 2012-03-27 Review 2012-02-17 Letter 2012-02-03 Letter 2011-09-29 Letter 2011-05-19 Letter 2009-05-08 Letter 2008-06-16 Letter 2007-07-05 Letter 2007-06-27 Label 2007-04-11 Review 2006-05-05 Letter 2005-12-13 Label 2005-12-13 Letter 2004-06-24 Letter 2004-06-23 Letter 2004-04-29 Letter 2002-08-09 Letter 2000-09-25 Review 2000-09-25 Label 2000-09-25 Letter 1998-12-23 Review 1998-12-23 Label 1998-12-13 Letter

Drug Adverse Effects information for NICORETTE (MINT)

Role code	Indications	Reaction	# Reports
PS	BIPOLAR DISORDER	DRUG ADMINISTRATION ERROR	3
PS	BIPOLAR DISORDER	DYSGRAPHIA	3
PS	BIPOLAR DISORDER	DYSKINESIA	1
PS	BIPOLAR DISORDER	EXTRAPYRAMIDAL DISORDER	1
PS	BIPOLAR DISORDER	MUSCULOSKELETAL DISORDER	3
PS	BIPOLAR DISORDER	NICOTINE DEPENDENCE	3
PS	BIPOLAR DISORDER	TREMOR	3
PS	EX-TOBACCO USER	ABDOMINAL DISCOMFORT	1
PS	EX-TOBACCO USER	ABDOMINAL PAIN UPPER	1
PS	EX-TOBACCO USER	AGEUSIA	1
PS	EX-TOBACCO USER	APHONIA	2
PS	EX-TOBACCO USER	ASTHENIA	1
PS	EX-TOBACCO USER	CHOKING SENSATION	1
PS	EX-TOBACCO USER	DIZZINESS	1
PS	EX-TOBACCO USER	DRUG ADMINISTRATION ERROR	6
PS	EX-TOBACCO USER	DRUG INEFFECTIVE	3
PS	EX-TOBACCO USER	DYSGEUSIA	1
PS	EX-TOBACCO USER	HEADACHE	1
PS	EX-TOBACCO USER	HICCUPS	1
PS	EX-TOBACCO USER	HYPERCHLORHYDRIA	2
PS	EX-TOBACCO USER	HYPOAESTHESIA ORAL	1
PS	EX-TOBACCO USER	INTENTIONAL DRUG MISUSE	2
PS	EX-TOBACCO USER	MALAISE	1
PS	EX-TOBACCO USER	NAUSEA	2
PS	EX-TOBACCO USER	NICOTINE DEPENDENCE	2
PS	EX-TOBACCO USER	ORAL DISCOMFORT	3
PS	EX-TOBACCO USER	OVERDOSE	1
PS	EX-TOBACCO USER	PHARYNGEAL OEDEMA	1
PS	EX-TOBACCO USER	PRODUCT QUALITY ISSUE	2
PS	EX-TOBACCO USER	SALIVARY HYPERSECRETION	1
PS	EX-TOBACCO USER	SENSATION OF FOREIGN BODY	2
PS	EX-TOBACCO USER	STOMATITIS	1
PS	EX-TOBACCO USER	THERMAL BURN	1
PS	EX-TOBACCO USER	THROAT IRRITATION	3
PS	EX-TOBACCO USER	VOMITING	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	ABDOMINAL DISCOMFORT	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	AGEUSIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DRUG ADMINISTRATION ERROR	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	INTENTIONAL DRUG MISUSE	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	NICOTINE DEPENDENCE	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	STOMATITIS	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	THERMAL BURN	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	VOMITING	1
PS	SMOKING CESSATION THERAPY	AGEUSIA	1
PS	SMOKING CESSATION THERAPY	DEPENDENCE	1
PS	SMOKING CESSATION THERAPY	DRUG ADMINISTRATION ERROR	6
PS	SMOKING CESSATION THERAPY	DRUG DEPENDENCE	1
PS	SMOKING CESSATION THERAPY	DYSGRAPHIA	3
PS	SMOKING CESSATION THERAPY	DYSKINESIA	1
PS	SMOKING CESSATION THERAPY	EXTRAPYRAMIDAL DISORDER	1
PS	SMOKING CESSATION THERAPY	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	SMOKING CESSATION THERAPY	INTENTIONAL DRUG MISUSE	4
PS	SMOKING CESSATION THERAPY	MUSCULOSKELETAL DISORDER	3
PS	SMOKING CESSATION THERAPY	NICOTINE DEPENDENCE	7
PS	SMOKING CESSATION THERAPY	THROAT IRRITATION	3
PS	SMOKING CESSATION THERAPY	TREMOR	3
SS	EX-TOBACCO USER	DIZZINESS	2
SS	EX-TOBACCO USER	DRUG ADMINISTRATION ERROR	2
SS	EX-TOBACCO USER	DRUG INEFFECTIVE	2
SS	EX-TOBACCO USER	NICOTINE DEPENDENCE	2
SS	EX-TOBACCO USER	ORAL PAIN	2
SS	EX-TOBACCO USER	PAIN IN JAW	2
SS	EX-TOBACCO USER	VOMITING	2
SS	SMOKING CESSATION THERAPY	DRUG ADMINISTRATION ERROR	1
SS	SMOKING CESSATION THERAPY	NICOTINE DEPENDENCE	1
SS	SMOKING CESSATION THERAPY	ORAL PAIN	1
SS	SMOKING CESSATION THERAPY	PAIN IN JAW	1

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