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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