Drug information for LORATADINE AND PSEUDOEPHEDRINE SULFATE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 10MG;240MG Over The Counter   LORATADINE; PSEUDOEPHEDRINE SULFATE Sch 434 WATSON LABS FLORIDA 75706
2003-12-24 Letter

2003-12-24 Label

2003-12-24 Review
TABLET, EXTENDED RELEASE; ORAL 10MG;240MG Over The Counter   LORATADINE; PSEUDOEPHEDRINE SULFATE Sch 434 IMPAX LABS 75989
2004-03-04 Review
TABLET, EXTENDED RELEASE; ORAL 5MG;120MG Over The Counter   LORATADINE; PSEUDOEPHEDRINE SULFATE Sch 434 IMPAX LABS 76050
2012-03-28 Review

2004-06-08 Letter
TABLET, EXTENDED RELEASE; ORAL 5MG;120MG Over The Counter   LORATADINE; PSEUDOEPHEDRINE SULFATE Sch 434 WATSON LABS FLORIDA 76208
2004-01-29 Letter
TABLET, EXTENDED RELEASE; ORAL 10MG;240MG Over The Counter   LORATADINE; PSEUDOEPHEDRINE SULFATE Sch 434 RANBAXY 76557
2011-02-15 Review

Drug Adverse Effects information for LORATADINE AND PSEUDOEPHEDRINE SULFATE

Role code Indications Reaction # Reports
PS HYPERSENSITIVITY DRUG INEFFECTIVE 2
PS PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 1
PS PRODUCT USED FOR UNKNOWN INDICATION COGNITIVE DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 1
PS PRODUCT USED FOR UNKNOWN INDICATION INSOMNIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME 1
PS PRODUCT USED FOR UNKNOWN INDICATION SLEEP DISORDER 1
PS SINUS DISORDER DRUG INEFFECTIVE 1
PS SINUSITIS DRUG INEFFECTIVE 1
SS HYPERSENSITIVITY DRUG INEFFECTIVE 2
SS SINUS DISORDER DRUG INEFFECTIVE 1
SS SINUSITIS DRUG INEFFECTIVE 1
C ACNE CHOLECYSTITIS 2
C ACNE CHOLECYSTITIS CHRONIC 2
C ACNE DYSPEPSIA 2
C ACNE EMOTIONAL DISTRESS 2
C ACNE GALLBLADDER DISORDER 1
C ACNE INJURY 2
C ACNE PAIN 2
C ACNE WEIGHT DECREASED 2
C ANALGESIC THERAPY CHOLECYSTITIS 6
C ANALGESIC THERAPY CHOLECYSTITIS CHRONIC 6
C ANALGESIC THERAPY DYSPEPSIA 6
C ANALGESIC THERAPY EMOTIONAL DISTRESS 6
C ANALGESIC THERAPY GALLBLADDER DISORDER 3
C ANALGESIC THERAPY INJURY 6
C ANALGESIC THERAPY PAIN 6
C ANALGESIC THERAPY WEIGHT DECREASED 6
C CELLULITIS ANAPHYLACTIC REACTION 1
C CONTRACEPTION CHOLECYSTITIS 2
C CONTRACEPTION CHOLECYSTITIS CHRONIC 2
C CONTRACEPTION DYSPEPSIA 2
C CONTRACEPTION EMOTIONAL DISTRESS 2
C CONTRACEPTION GALLBLADDER DISORDER 1
C CONTRACEPTION INJURY 2
C CONTRACEPTION PAIN 2
C CONTRACEPTION WEIGHT DECREASED 2
C HEADACHE ABDOMINAL PAIN UPPER 4
C HEADACHE ANAEMIA 4
C HEADACHE AORTIC CALCIFICATION 4
C HEADACHE ARTHRALGIA 4
C HEADACHE ARTHROPATHY 4
C HEADACHE ATRIAL FIBRILLATION 4
C HEADACHE BACTERIAL SEPSIS 4
C HEADACHE BONE LESION 4
C HEADACHE BURSITIS 4
C HEADACHE CARDIOMEGALY 4
C HEADACHE CEREBRAL INFARCTION 4
C HEADACHE COMA 4
C HEADACHE COMPRESSION FRACTURE 4
C HEADACHE CONSTIPATION 4
C HEADACHE COUGH 4
C HEADACHE DIABETES MELLITUS INADEQUATE CONTROL 4
C HEADACHE DISCOMFORT 4
C HEADACHE EXOSTOSIS 4
C HEADACHE HEADACHE 4
C HEADACHE HYPERTENSION 4
C HEADACHE HYPOGLYCAEMIA 4
C HEADACHE INFLUENZA 4
C HEADACHE LUNG INFILTRATION 4
C HEADACHE MITRAL VALVE INCOMPETENCE 4
C HEADACHE NEPHROLITHIASIS 4
C HEADACHE NEURODEGENERATIVE DISORDER 4
C HEADACHE OSTEOPOROSIS 4
C HEADACHE PULMONARY HYPERTENSION 4
C HEADACHE PYREXIA 4
C HEADACHE RHEUMATOID ARTHRITIS 4
C HEADACHE RHINORRHOEA 4
C HEADACHE SCOLIOSIS 4
C HEADACHE SPINAL OSTEOARTHRITIS 4
C HEADACHE TEMPORAL ARTERITIS 4
C HEADACHE TENDONITIS 4
C HEADACHE TRICUSPID VALVE INCOMPETENCE 4
C HEADACHE WEIGHT DECREASED 4
C HYPERSENSITIVITY CHOLECYSTITIS 2
C HYPERSENSITIVITY CHOLECYSTITIS CHRONIC 2
C HYPERSENSITIVITY DYSPEPSIA 2
C HYPERSENSITIVITY EMOTIONAL DISTRESS 2
C HYPERSENSITIVITY GALLBLADDER DISORDER 1
C HYPERSENSITIVITY INJURY 2
C HYPERSENSITIVITY PAIN 2
C HYPERSENSITIVITY WEIGHT DECREASED 2
C MOUTH ULCERATION ABDOMINAL PAIN UPPER 2
C MOUTH ULCERATION ANAEMIA 2
C MOUTH ULCERATION AORTIC CALCIFICATION 2
C MOUTH ULCERATION ARTHRALGIA 2
C MOUTH ULCERATION ARTHROPATHY 2
C MOUTH ULCERATION ATRIAL FIBRILLATION 2
C MOUTH ULCERATION BACTERIAL SEPSIS 2
C MOUTH ULCERATION BONE LESION 2
C MOUTH ULCERATION BURSITIS 2
C MOUTH ULCERATION CARDIOMEGALY 2
C MOUTH ULCERATION CEREBRAL INFARCTION 2
C MOUTH ULCERATION COMA 2
C MOUTH ULCERATION COMPRESSION FRACTURE 2
C MOUTH ULCERATION CONSTIPATION 2
C MOUTH ULCERATION COUGH 2
C MOUTH ULCERATION DIABETES MELLITUS INADEQUATE CONTROL 2
C MOUTH ULCERATION DISCOMFORT 2
C MOUTH ULCERATION EXOSTOSIS 2
C MOUTH ULCERATION HEADACHE 2
C MOUTH ULCERATION HYPERTENSION 2
C MOUTH ULCERATION HYPOGLYCAEMIA 2
C MOUTH ULCERATION INFLUENZA 2
C MOUTH ULCERATION LUNG INFILTRATION 2
C MOUTH ULCERATION MITRAL VALVE INCOMPETENCE 2
C MOUTH ULCERATION NEPHROLITHIASIS 2
C MOUTH ULCERATION NEURODEGENERATIVE DISORDER 2
C MOUTH ULCERATION OSTEOPOROSIS 2
C MOUTH ULCERATION PULMONARY HYPERTENSION 2
C MOUTH ULCERATION PYREXIA 2
C MOUTH ULCERATION RHEUMATOID ARTHRITIS 2
C MOUTH ULCERATION RHINORRHOEA 2
C MOUTH ULCERATION SCOLIOSIS 2
C MOUTH ULCERATION SPINAL OSTEOARTHRITIS 2
C MOUTH ULCERATION TEMPORAL ARTERITIS 2
C MOUTH ULCERATION TENDONITIS 2
C MOUTH ULCERATION TRICUSPID VALVE INCOMPETENCE 2
C MOUTH ULCERATION WEIGHT DECREASED 2
C PREMENSTRUAL SYNDROME CHOLECYSTITIS 2
C PREMENSTRUAL SYNDROME CHOLECYSTITIS CHRONIC 2
C PREMENSTRUAL SYNDROME DYSPEPSIA 2
C PREMENSTRUAL SYNDROME EMOTIONAL DISTRESS 2
C PREMENSTRUAL SYNDROME GALLBLADDER DISORDER 1
C PREMENSTRUAL SYNDROME INJURY 2
C PREMENSTRUAL SYNDROME PAIN 2
C PREMENSTRUAL SYNDROME WEIGHT DECREASED 2
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN UPPER 66
C PRODUCT USED FOR UNKNOWN INDICATION ANAEMIA 66
C PRODUCT USED FOR UNKNOWN INDICATION AORTIC CALCIFICATION 66
C PRODUCT USED FOR UNKNOWN INDICATION ARTHRALGIA 66
C PRODUCT USED FOR UNKNOWN INDICATION ARTHROPATHY 66
C PRODUCT USED FOR UNKNOWN INDICATION ATRIAL FIBRILLATION 66
C PRODUCT USED FOR UNKNOWN INDICATION BACTERIAL SEPSIS 66
C PRODUCT USED FOR UNKNOWN INDICATION BONE LESION 66
C PRODUCT USED FOR UNKNOWN INDICATION BURNING SENSATION 1
C PRODUCT USED FOR UNKNOWN INDICATION BURSITIS 66
C PRODUCT USED FOR UNKNOWN INDICATION CARDIOMEGALY 66
C PRODUCT USED FOR UNKNOWN INDICATION CEREBRAL INFARCTION 66
C PRODUCT USED FOR UNKNOWN INDICATION COMA 66
C PRODUCT USED FOR UNKNOWN INDICATION COMPRESSION FRACTURE 66
C PRODUCT USED FOR UNKNOWN INDICATION CONSTIPATION 66
C PRODUCT USED FOR UNKNOWN INDICATION COUGH 66
C PRODUCT USED FOR UNKNOWN INDICATION DIABETES MELLITUS INADEQUATE CONTROL 66
C PRODUCT USED FOR UNKNOWN INDICATION DISCOMFORT 66
C PRODUCT USED FOR UNKNOWN INDICATION EXOSTOSIS 66
C PRODUCT USED FOR UNKNOWN INDICATION FEELING HOT 1
C PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 66
C PRODUCT USED FOR UNKNOWN INDICATION HYPERTENSION 66
C PRODUCT USED FOR UNKNOWN INDICATION HYPOGLYCAEMIA 66
C PRODUCT USED FOR UNKNOWN INDICATION INFLUENZA 66
C PRODUCT USED FOR UNKNOWN INDICATION LUNG INFILTRATION 66
C PRODUCT USED FOR UNKNOWN INDICATION MITRAL VALVE INCOMPETENCE 66
C PRODUCT USED FOR UNKNOWN INDICATION NEPHROLITHIASIS 66
C PRODUCT USED FOR UNKNOWN INDICATION NEURODEGENERATIVE DISORDER 66
C PRODUCT USED FOR UNKNOWN INDICATION OSTEOPOROSIS 66
C PRODUCT USED FOR UNKNOWN INDICATION PULMONARY HYPERTENSION 66
C PRODUCT USED FOR UNKNOWN INDICATION PYREXIA 66
C PRODUCT USED FOR UNKNOWN INDICATION RHEUMATOID ARTHRITIS 66
C PRODUCT USED FOR UNKNOWN INDICATION RHINORRHOEA 66
C PRODUCT USED FOR UNKNOWN INDICATION SCOLIOSIS 66
C PRODUCT USED FOR UNKNOWN INDICATION SPINAL OSTEOARTHRITIS 66
C PRODUCT USED FOR UNKNOWN INDICATION TEMPORAL ARTERITIS 66
C PRODUCT USED FOR UNKNOWN INDICATION TENDONITIS 66
C PRODUCT USED FOR UNKNOWN INDICATION TRICUSPID VALVE INCOMPETENCE 66
C PRODUCT USED FOR UNKNOWN INDICATION WEIGHT DECREASED 66
C PYREXIA ABDOMINAL PAIN UPPER 2
C PYREXIA ANAEMIA 2
C PYREXIA AORTIC CALCIFICATION 2
C PYREXIA ARTHRALGIA 2
C PYREXIA ARTHROPATHY 2
C PYREXIA ATRIAL FIBRILLATION 2
C PYREXIA BACTERIAL SEPSIS 2
C PYREXIA BONE LESION 2
C PYREXIA BURSITIS 2
C PYREXIA CARDIOMEGALY 2
C PYREXIA CEREBRAL INFARCTION 2
C PYREXIA COMA 2
C PYREXIA COMPRESSION FRACTURE 2
C PYREXIA CONSTIPATION 2
C PYREXIA COUGH 2
C PYREXIA DIABETES MELLITUS INADEQUATE CONTROL 2
C PYREXIA DISCOMFORT 2
C PYREXIA EXOSTOSIS 2
C PYREXIA HEADACHE 2
C PYREXIA HYPERTENSION 2
C PYREXIA HYPOGLYCAEMIA 2
C PYREXIA INFLUENZA 2
C PYREXIA LUNG INFILTRATION 2
C PYREXIA MITRAL VALVE INCOMPETENCE 2
C PYREXIA NEPHROLITHIASIS 2
C PYREXIA NEURODEGENERATIVE DISORDER 2
C PYREXIA OSTEOPOROSIS 2
C PYREXIA PULMONARY HYPERTENSION 2
C PYREXIA PYREXIA 2
C PYREXIA RHEUMATOID ARTHRITIS 2
C PYREXIA RHINORRHOEA 2
C PYREXIA SCOLIOSIS 2
C PYREXIA SPINAL OSTEOARTHRITIS 2
C PYREXIA TEMPORAL ARTERITIS 2
C PYREXIA TENDONITIS 2
C PYREXIA TRICUSPID VALVE INCOMPETENCE 2
C PYREXIA WEIGHT DECREASED 2
C RHEUMATOID ARTHRITIS ABDOMINAL PAIN UPPER 2
C RHEUMATOID ARTHRITIS ANAEMIA 2
C RHEUMATOID ARTHRITIS AORTIC CALCIFICATION 2
C RHEUMATOID ARTHRITIS ARTHRALGIA 2
C RHEUMATOID ARTHRITIS ARTHROPATHY 2
C RHEUMATOID ARTHRITIS ATRIAL FIBRILLATION 2
C RHEUMATOID ARTHRITIS BACTERIAL SEPSIS 2
C RHEUMATOID ARTHRITIS BONE LESION 2
C RHEUMATOID ARTHRITIS BURSITIS 2
C RHEUMATOID ARTHRITIS CARDIOMEGALY 2
C RHEUMATOID ARTHRITIS CEREBRAL INFARCTION 2
C RHEUMATOID ARTHRITIS COMA 2
C RHEUMATOID ARTHRITIS COMPRESSION FRACTURE 2
C RHEUMATOID ARTHRITIS CONSTIPATION 2
C RHEUMATOID ARTHRITIS COUGH 2
C RHEUMATOID ARTHRITIS DIABETES MELLITUS INADEQUATE CONTROL 2
C RHEUMATOID ARTHRITIS DISCOMFORT 2
C RHEUMATOID ARTHRITIS EXOSTOSIS 2
C RHEUMATOID ARTHRITIS HEADACHE 2
C RHEUMATOID ARTHRITIS HYPERTENSION 2
C RHEUMATOID ARTHRITIS HYPOGLYCAEMIA 2
C RHEUMATOID ARTHRITIS INFLUENZA 2
C RHEUMATOID ARTHRITIS LUNG INFILTRATION 2
C RHEUMATOID ARTHRITIS MITRAL VALVE INCOMPETENCE 2
C RHEUMATOID ARTHRITIS NEPHROLITHIASIS 2
C RHEUMATOID ARTHRITIS NEURODEGENERATIVE DISORDER 2
C RHEUMATOID ARTHRITIS OSTEOPOROSIS 2
C RHEUMATOID ARTHRITIS PULMONARY HYPERTENSION 2
C RHEUMATOID ARTHRITIS PYREXIA 2
C RHEUMATOID ARTHRITIS RHEUMATOID ARTHRITIS 2
C RHEUMATOID ARTHRITIS RHINORRHOEA 2
C RHEUMATOID ARTHRITIS SCOLIOSIS 2
C RHEUMATOID ARTHRITIS SPINAL OSTEOARTHRITIS 2
C RHEUMATOID ARTHRITIS TEMPORAL ARTERITIS 2
C RHEUMATOID ARTHRITIS TENDONITIS 2
C RHEUMATOID ARTHRITIS TRICUSPID VALVE INCOMPETENCE 2
C RHEUMATOID ARTHRITIS WEIGHT DECREASED 2
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