Drug information for NICOTINE POLACRILEX

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX WATSON LABS 74507
2004-06-10 Label

2003-04-30 Review

1999-03-15 Letter
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX WATSON LABS 74707
2004-06-10 Label

1999-03-19 Letter

1999-03-19 Review
GUM, CHEWING; BUCCAL EQ 2MG BASE Discontinued   NICOTINE POLACRILEX WATSON LABS 76568
2004-07-30 Letter
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX WATSON LABS   "
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX WATSON LABS 76569
2004-07-30 Letter
GUM, CHEWING; BUCCAL EQ 4MG BASE Discontinued   NICOTINE POLACRILEX WATSON LABS   "
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX PERRIGO 76775
2007-07-06 Review
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX PERRIGO 76776
2007-07-06 Review
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX PERRIGO 76777
2007-07-06 Review
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX PERRIGO 76778
2007-05-09 Review
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX PERRIGO 76779
2007-05-09 Review
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX PERRIGO 76789
2007-05-09 Review
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products IVAX SUB TEVA PHARMS 76880
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products IVAX SUB TEVA PHARMS 77850
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX PERRIGO R AND D 78325
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX PERRIGO R AND D 78326
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products PERRIGO R AND D 78546
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products PERRIGO R AND D 78547
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products WATSON LABS 78697
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products WATSON LABS 78699
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products PERRIGO R AND D 78967
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products PERRIGO R AND D 78968
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products WATSON LABS 79038
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products WATSON LABS 79044
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products WATSON LABS 79216
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products WATSON LABS 79219
GUM, CHEWING; BUCCAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products PERRIGO R AND D 91349
GUM, CHEWING; BUCCAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products PERRIGO R AND D 91354
TROCHE/LOZENGE; ORAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX PERRIGO R AND D 77007
2006-02-02 Letter
TROCHE/LOZENGE; ORAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX PERRIGO R AND D   "
TROCHE/LOZENGE; ORAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products PERRIGO R AND D 90711
TROCHE/LOZENGE; ORAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products PERRIGO R AND D   "
TROCHE/LOZENGE; ORAL EQ 2MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products PERRIGO R AND D 90821
TROCHE/LOZENGE; ORAL EQ 4MG BASE Over The Counter   NICOTINE POLACRILEX Tobacco Use Cessation Products PERRIGO R AND D   "

Drug Adverse Effects information for NICOTINE POLACRILEX

Role code Indications Reaction # Reports
PS EX-TOBACCO USER ABDOMINAL DISCOMFORT 3
PS EX-TOBACCO USER ABDOMINAL PAIN UPPER 2
PS EX-TOBACCO USER ACCIDENTAL EXPOSURE 6
PS EX-TOBACCO USER ADVERSE EVENT 1
PS EX-TOBACCO USER APPLICATION SITE BURN 2
PS EX-TOBACCO USER APPLICATION SITE PAIN 2
PS EX-TOBACCO USER APPLICATION SITE PRURITUS 2
PS EX-TOBACCO USER BLOOD GLUCOSE INCREASED 1
PS EX-TOBACCO USER CHEST DISCOMFORT 1
PS EX-TOBACCO USER CHEST PAIN 1
PS EX-TOBACCO USER CONDITION AGGRAVATED 1
PS EX-TOBACCO USER COUGH 1
PS EX-TOBACCO USER DECREASED APPETITE 2
PS EX-TOBACCO USER DENTAL CARIES 1
PS EX-TOBACCO USER DEPRESSION 1
PS EX-TOBACCO USER DERMATITIS CONTACT 2
PS EX-TOBACCO USER DEVICE COLOUR ISSUE 1
PS EX-TOBACCO USER DIARRHOEA 2
PS EX-TOBACCO USER DISCOMFORT 1
PS EX-TOBACCO USER DISORIENTATION 2
PS EX-TOBACCO USER DISSOCIATION 1
PS EX-TOBACCO USER DIZZINESS 5
PS EX-TOBACCO USER DRUG ADMINISTRATION ERROR 21
PS EX-TOBACCO USER DRUG INEFFECTIVE 10
PS EX-TOBACCO USER DRY MOUTH 1
PS EX-TOBACCO USER DRY SKIN 2
PS EX-TOBACCO USER DYSGEUSIA 1
PS EX-TOBACCO USER DYSPEPSIA 7
PS EX-TOBACCO USER DYSPHAGIA 1
PS EX-TOBACCO USER DYSPNOEA 2
PS EX-TOBACCO USER EXPIRED DRUG ADMINISTERED 7
PS EX-TOBACCO USER FACIAL PAIN 2
PS EX-TOBACCO USER FEELING ABNORMAL 3
PS EX-TOBACCO USER FOREIGN BODY 1
PS EX-TOBACCO USER GAIT DISTURBANCE 2
PS EX-TOBACCO USER GINGIVAL BLEEDING 1
PS EX-TOBACCO USER GINGIVAL INJURY 1
PS EX-TOBACCO USER GINGIVAL PAIN 3
PS EX-TOBACCO USER GINGIVITIS 1
PS EX-TOBACCO USER GLOSSODYNIA 2
PS EX-TOBACCO USER HEADACHE 2
PS EX-TOBACCO USER HEART RATE INCREASED 2
PS EX-TOBACCO USER HYPERHIDROSIS 1
PS EX-TOBACCO USER HYPERSENSITIVITY 5
PS EX-TOBACCO USER INSOMNIA 2
PS EX-TOBACCO USER INTENTIONAL DRUG MISUSE 19
PS EX-TOBACCO USER KIDNEY INFECTION 2
PS EX-TOBACCO USER LARYNX IRRITATION 1
PS EX-TOBACCO USER LEUKOPLAKIA ORAL 1
PS EX-TOBACCO USER LIP DISORDER 1
PS EX-TOBACCO USER MALAISE 10
PS EX-TOBACCO USER MOUTH ULCERATION 2
PS EX-TOBACCO USER MUSCLE SPASMS 1
PS EX-TOBACCO USER MUSCULAR WEAKNESS 2
PS EX-TOBACCO USER NASAL DISCOMFORT 1
PS EX-TOBACCO USER NAUSEA 9
PS EX-TOBACCO USER NICOTINE DEPENDENCE 25
PS EX-TOBACCO USER OCULAR HYPERAEMIA 2
PS EX-TOBACCO USER OESOPHAGEAL PAIN 3
PS EX-TOBACCO USER ORAL DISCOMFORT 2
PS EX-TOBACCO USER ORAL PAIN 3
PS EX-TOBACCO USER OROPHARYNGEAL DISCOMFORT 2
PS EX-TOBACCO USER OROPHARYNGEAL PAIN 3
PS EX-TOBACCO USER PAIN 1
PS EX-TOBACCO USER PALPITATIONS 2
PS EX-TOBACCO USER PRODUCT QUALITY ISSUE 18
PS EX-TOBACCO USER RETCHING 1
PS EX-TOBACCO USER SENSATION OF FOREIGN BODY 3
PS EX-TOBACCO USER SENSITIVITY OF TEETH 1
PS EX-TOBACCO USER STOMATITIS 2
PS EX-TOBACCO USER SUFFOCATION FEELING 1
PS EX-TOBACCO USER THROAT IRRITATION 2
PS EX-TOBACCO USER TONGUE DISORDER 1
PS EX-TOBACCO USER TOOTH DISORDER 2
PS EX-TOBACCO USER TOOTH INJURY 1
PS EX-TOBACCO USER TOOTH REPAIR 1
PS EX-TOBACCO USER URTICARIA 2
PS EX-TOBACCO USER VOMITING 2
PS EX-TOBACCO USER WITHDRAWAL SYNDROME 1
PS NICOTINE DEPENDENCE DENTAL CARIES 1
PS NICOTINE DEPENDENCE DEPRESSION 1
PS NICOTINE DEPENDENCE GINGIVITIS 1
PS NICOTINE DEPENDENCE INTENTIONAL DRUG MISUSE 1
PS NICOTINE DEPENDENCE NICOTINE DEPENDENCE 1
PS NICOTINE DEPENDENCE PAIN 1
PS NICOTINE DEPENDENCE TOOTH DISORDER 1
PS NICOTINE DEPENDENCE TOOTH INJURY 1
PS NICOTINE DEPENDENCE TOOTH REPAIR 1
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG ADMINISTRATION ERROR 1
PS PRODUCT USED FOR UNKNOWN INDICATION GINGIVAL PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION INTENTIONAL DRUG MISUSE 4
PS PRODUCT USED FOR UNKNOWN INDICATION NICOTINE DEPENDENCE 3
PS PRODUCT USED FOR UNKNOWN INDICATION PRODUCT QUALITY ISSUE 1
PS PRODUCT USED FOR UNKNOWN INDICATION RETCHING 1
PS PRODUCT USED FOR UNKNOWN INDICATION STOMATITIS 1
PS SMOKING CESSATION THERAPY DRUG ADMINISTRATION ERROR 5
PS SMOKING CESSATION THERAPY GINGIVAL BLEEDING 1
PS SMOKING CESSATION THERAPY GINGIVITIS 1
PS SMOKING CESSATION THERAPY HEART RATE INCREASED 1
PS SMOKING CESSATION THERAPY INCORRECT DRUG ADMINISTRATION DURATION 4
PS SMOKING CESSATION THERAPY INTENTIONAL DRUG MISUSE 5
PS SMOKING CESSATION THERAPY MENTAL IMPAIRMENT 1
PS SMOKING CESSATION THERAPY NAUSEA 2
PS SMOKING CESSATION THERAPY NICOTINE DEPENDENCE 11
PS SMOKING CESSATION THERAPY OVERDOSE 4
PS SMOKING CESSATION THERAPY PRURITUS GENERALISED 1
PS SMOKING CESSATION THERAPY RECTAL CANCER 4
PS SMOKING CESSATION THERAPY TOBACCO ABUSE 4
PS SMOKING CESSATION THERAPY TOOTH EXTRACTION 1
PS SMOKING CESSATION THERAPY URTICARIA 1
PS TOBACCO USER DRUG ADMINISTRATION ERROR 1
PS TOBACCO USER NICOTINE DEPENDENCE 1
SS ANTICOAGULANT THERAPY LACERATION 1
SS ANTICOAGULANT THERAPY LIPOATROPHY 1
SS ANTICOAGULANT THERAPY SKIN ATROPHY 1
SS ANTICOAGULANT THERAPY SKIN WRINKLING 1
SS BLOOD CHOLESTEROL INCREASED LACERATION 1
SS BLOOD CHOLESTEROL INCREASED LIPOATROPHY 1
SS BLOOD CHOLESTEROL INCREASED SKIN ATROPHY 1
SS BLOOD CHOLESTEROL INCREASED SKIN WRINKLING 1
SS CARDIAC DISORDER LACERATION 2
SS CARDIAC DISORDER LIPOATROPHY 2
SS CARDIAC DISORDER SKIN ATROPHY 2
SS CARDIAC DISORDER SKIN WRINKLING 2
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE LACERATION 4
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE LIPOATROPHY 4
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE SKIN ATROPHY 4
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE SKIN WRINKLING 4
SS COAGULOPATHY LACERATION 1
SS COAGULOPATHY LIPOATROPHY 1
SS COAGULOPATHY SKIN ATROPHY 1
SS COAGULOPATHY SKIN WRINKLING 1
SS EX-TOBACCO USER ABDOMINAL DISCOMFORT 2
SS EX-TOBACCO USER BURNING SENSATION 2
SS EX-TOBACCO USER DECREASED APPETITE 2
SS EX-TOBACCO USER DENTAL CARIES 2
SS EX-TOBACCO USER DIARRHOEA 2
SS EX-TOBACCO USER DISORIENTATION 2
SS EX-TOBACCO USER DIZZINESS 4
SS EX-TOBACCO USER DRUG ADMINISTRATION ERROR 28
SS EX-TOBACCO USER DRUG INEFFECTIVE 6
SS EX-TOBACCO USER DRY SKIN 2
SS EX-TOBACCO USER EXPIRED DRUG ADMINISTERED 2
SS EX-TOBACCO USER FACIAL PAIN 2
SS EX-TOBACCO USER FATIGUE 2
SS EX-TOBACCO USER FEELING ABNORMAL 2
SS EX-TOBACCO USER GAIT DISTURBANCE 2
SS EX-TOBACCO USER GINGIVAL PAIN 2
SS EX-TOBACCO USER HEART RATE INCREASED 2
SS EX-TOBACCO USER HYPERSENSITIVITY 2
SS EX-TOBACCO USER INTENTIONAL DRUG MISUSE 18
SS EX-TOBACCO USER KIDNEY INFECTION 2
SS EX-TOBACCO USER MUSCULAR WEAKNESS 2
SS EX-TOBACCO USER NAUSEA 6
SS EX-TOBACCO USER NICOTINE DEPENDENCE 20
SS EX-TOBACCO USER OCULAR HYPERAEMIA 2
SS EX-TOBACCO USER ORAL PAIN 2
SS EX-TOBACCO USER OROPHARYNGEAL PAIN 2
SS EX-TOBACCO USER PRODUCT QUALITY ISSUE 12
SS EX-TOBACCO USER PRODUCTIVE COUGH 2
SS EX-TOBACCO USER STOMATITIS 12
SS HYPERCHOLESTEROLAEMIA LACERATION 1
SS HYPERCHOLESTEROLAEMIA LIPOATROPHY 1
SS HYPERCHOLESTEROLAEMIA SKIN ATROPHY 1
SS HYPERCHOLESTEROLAEMIA SKIN WRINKLING 1
SS NICOTINE DEPENDENCE LACERATION 2
SS NICOTINE DEPENDENCE LIPOATROPHY 2
SS NICOTINE DEPENDENCE SKIN ATROPHY 2
SS NICOTINE DEPENDENCE SKIN WRINKLING 2
SS OFF LABEL USE DRUG ADMINISTRATION ERROR 1
SS OFF LABEL USE THERAPEUTIC RESPONSE UNEXPECTED 1
SS SMOKING CESSATION THERAPY DRUG ADMINISTRATION ERROR 3
SS SMOKING CESSATION THERAPY GINGIVAL BLEEDING 2
SS SMOKING CESSATION THERAPY GINGIVITIS 2
SS SMOKING CESSATION THERAPY INCORRECT DRUG ADMINISTRATION DURATION 4
SS SMOKING CESSATION THERAPY INTENTIONAL DRUG MISUSE 2
SS SMOKING CESSATION THERAPY NAUSEA 2
SS SMOKING CESSATION THERAPY NICOTINE DEPENDENCE 6
SS SMOKING CESSATION THERAPY OVERDOSE 4
SS SMOKING CESSATION THERAPY PRURITUS GENERALISED 1
SS SMOKING CESSATION THERAPY RECTAL CANCER 4
SS SMOKING CESSATION THERAPY THERAPEUTIC RESPONSE UNEXPECTED 1
SS SMOKING CESSATION THERAPY TOBACCO ABUSE 4
SS SMOKING CESSATION THERAPY TOOTH EXTRACTION 2
SS SMOKING CESSATION THERAPY URTICARIA 1
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