Drug information for NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL EQ 200MG BASE;120MG Over The Counter   NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE Naproxen PERRIGO 76518
2004-03-19 Letter
TABLET, EXTENDED RELEASE; ORAL EQ 220MG BASE;120MG Over The Counter   NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE Naproxen DR REDDYS LABS INC 77381
2006-10-10 Other Important Information from FDA
2006-10-10 Healthcare Professional Sheet

Drug Adverse Effects information for NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

Role code Indications Reaction # Reports
C ACNE ABDOMINAL DISTENSION 1
C ACNE ABDOMINAL PAIN 3
C ACNE ABDOMINAL PAIN UPPER 1
C ACNE ANXIETY 1
C ACNE BILIARY DYSKINESIA 3
C ACNE CEREBROVASCULAR ACCIDENT 2
C ACNE CHOLECYSTECTOMY 3
C ACNE CHOLECYSTITIS 3
C ACNE CHOLECYSTITIS CHRONIC 10
C ACNE CONSTIPATION 1
C ACNE DEEP VEIN THROMBOSIS 2
C ACNE DEPRESSION 1
C ACNE DIARRHOEA 1
C ACNE DYSPEPSIA 1
C ACNE FLATULENCE 1
C ACNE GALLBLADDER DISORDER 9
C ACNE GASTROOESOPHAGEAL REFLUX DISEASE 3
C ACNE HEADACHE 2
C ACNE INJURY 5
C ACNE MYOCARDIAL INFARCTION 2
C ACNE PAIN 5
C ACNE PULMONARY EMBOLISM 2
C ACNE SCAR 1
C ACNE SLEEP DISORDER 2
C BACK PAIN ABDOMINAL PAIN 3
C BACK PAIN CHOLECYSTITIS CHRONIC 3
C BACK PAIN CONTUSION 1
C BACK PAIN GALLBLADDER DISORDER 3
C BACK PAIN GASTROOESOPHAGEAL REFLUX DISEASE 3
C BACK PAIN HEART RATE DECREASED 1
C BACK PAIN HEART RATE INCREASED 1
C BACK PAIN PALPITATIONS 1
C CHEST PAIN ABDOMINAL PAIN 3
C CHEST PAIN CHOLECYSTITIS CHRONIC 3
C CHEST PAIN GALLBLADDER DISORDER 3
C CHEST PAIN GASTROOESOPHAGEAL REFLUX DISEASE 3
C CONSTIPATION PULMONARY EMBOLISM 2
C CONTRACEPTION ABDOMINAL PAIN 3
C CONTRACEPTION ABDOMINAL PAIN UPPER 1
C CONTRACEPTION ANXIETY 1
C CONTRACEPTION BACK PAIN 1
C CONTRACEPTION BILIARY DYSKINESIA 1
C CONTRACEPTION BLOOD PRESSURE INCREASED 1
C CONTRACEPTION CEREBROVASCULAR ACCIDENT 1
C CONTRACEPTION CHOLECYSTECTOMY 3
C CONTRACEPTION CHOLECYSTITIS 1
C CONTRACEPTION CHOLECYSTITIS CHRONIC 7
C CONTRACEPTION CONTUSION 1
C CONTRACEPTION DEEP VEIN THROMBOSIS 1
C CONTRACEPTION DEPRESSION 1
C CONTRACEPTION DYSPNOEA 1
C CONTRACEPTION EPISTAXIS 1
C CONTRACEPTION GALLBLADDER DISORDER 4
C CONTRACEPTION GASTROOESOPHAGEAL REFLUX DISEASE 3
C CONTRACEPTION HEART RATE INCREASED 1
C CONTRACEPTION LETHARGY 1
C CONTRACEPTION MYOCARDIAL INFARCTION 1
C CONTRACEPTION PAIN 1
C CONTRACEPTION PULMONARY EMBOLISM 1
C HEADACHE ABDOMINAL DISTENSION 2
C HEADACHE ABDOMINAL PAIN 3
C HEADACHE ANXIETY 4
C HEADACHE BILIARY DYSKINESIA 12
C HEADACHE CEREBROVASCULAR ACCIDENT 12
C HEADACHE CHOLECYSTECTOMY 2
C HEADACHE CHOLECYSTITIS CHRONIC 17
C HEADACHE CONSTIPATION 2
C HEADACHE DEEP VEIN THROMBOSIS 12
C HEADACHE DEPRESSION 2
C HEADACHE DIARRHOEA 2
C HEADACHE DYSPEPSIA 2
C HEADACHE EMOTIONAL DISTRESS 2
C HEADACHE FLATULENCE 2
C HEADACHE GALLBLADDER DISORDER 15
C HEADACHE GASTROOESOPHAGEAL REFLUX DISEASE 3
C HEADACHE HEADACHE 12
C HEADACHE INJURY 14
C HEADACHE MYOCARDIAL INFARCTION 12
C HEADACHE PAIN 14
C HEADACHE PULMONARY EMBOLISM 12
C HEADACHE SCAR 2
C HEADACHE SLEEP DISORDER 12
C HEADACHE THROMBOSIS 2
C HEART RATE INCREASED PULMONARY EMBOLISM 1
C HYPERTENSION BACK PAIN 1
C HYPERTENSION BLOOD PRESSURE INCREASED 1
C HYPERTENSION CONTUSION 1
C HYPERTENSION DYSPNOEA 1
C HYPERTENSION EPISTAXIS 1
C HYPERTENSION HEART RATE INCREASED 1
C HYPERTENSION LETHARGY 1
C HYPERTENSION PULMONARY EMBOLISM 1
C HYPOTHYROIDISM BACK PAIN 1
C HYPOTHYROIDISM BLOOD PRESSURE INCREASED 1
C HYPOTHYROIDISM CONTUSION 1
C HYPOTHYROIDISM DYSPNOEA 1
C HYPOTHYROIDISM EPISTAXIS 1
C HYPOTHYROIDISM HEART RATE INCREASED 1
C HYPOTHYROIDISM LETHARGY 1
C HYPOTHYROIDISM PULMONARY EMBOLISM 1
C INSOMNIA PULMONARY EMBOLISM 1
C MENSTRUAL CYCLE MANAGEMENT ABDOMINAL PAIN 1
C MENSTRUAL CYCLE MANAGEMENT ASPARTATE AMINOTRANSFERASE INCREASED 1
C MENSTRUAL CYCLE MANAGEMENT BACK PAIN 1
C MENSTRUAL CYCLE MANAGEMENT BLOOD ALKALINE PHOSPHATASE INCREASED 1
C MENSTRUAL CYCLE MANAGEMENT BLOOD BILIRUBIN INCREASED 1
C MENSTRUAL CYCLE MANAGEMENT CHOLECYSTITIS CHRONIC 1
C MENSTRUAL CYCLE MANAGEMENT CHOLELITHIASIS 1
C MENSTRUAL CYCLE MANAGEMENT DRUG DOSE OMISSION 1
C MENSTRUAL CYCLE MANAGEMENT DUODENITIS 1
C MENSTRUAL CYCLE MANAGEMENT GALLBLADDER DISORDER 1
C MENSTRUAL CYCLE MANAGEMENT GALLBLADDER INJURY 1
C MENSTRUAL CYCLE MANAGEMENT GALLBLADDER OBSTRUCTION 1
C MENSTRUAL CYCLE MANAGEMENT GASTRIC ULCER 1
C MENSTRUAL CYCLE MANAGEMENT METRORRHAGIA 1
C MENSTRUAL CYCLE MANAGEMENT PANCREATITIS 1
C MENSTRUAL CYCLE MANAGEMENT PEPTIC ULCER 1
C MENSTRUAL DISORDER CHOLECYSTECTOMY 2
C MENSTRUAL DISORDER CHOLECYSTITIS 2
C MENSTRUAL DISORDER INJURY 2
C MENSTRUAL DISORDER PAIN 2
C MENSTRUATION IRREGULAR INJURY 1
C MENSTRUATION IRREGULAR PLEURAL EFFUSION 1
C MENSTRUATION IRREGULAR PULMONARY EMBOLISM 1
C MENSTRUATION IRREGULAR THROMBOSIS 1
C MIGRAINE DEHYDRATION 1
C MIGRAINE GALLBLADDER INJURY 1
C MIGRAINE INJURY 1
C MIGRAINE PAIN 1
C MOOD SWINGS INJURY 1
C MOOD SWINGS PLEURAL EFFUSION 1
C MOOD SWINGS PULMONARY EMBOLISM 1
C MOOD SWINGS THROMBOSIS 1
C NECK PAIN BACK PAIN 1
C NECK PAIN BLOOD PRESSURE INCREASED 1
C NECK PAIN CONTUSION 1
C NECK PAIN DYSPNOEA 1
C NECK PAIN EPISTAXIS 1
C NECK PAIN HEART RATE INCREASED 1
C NECK PAIN LETHARGY 1
C NECK PAIN PULMONARY EMBOLISM 1
C ORAL CONTRACEPTION ALOPECIA 2
C ORAL CONTRACEPTION BILIARY DYSKINESIA 2
C ORAL CONTRACEPTION CARDIAC DISORDER 2
C ORAL CONTRACEPTION CEREBROVASCULAR ACCIDENT 2
C ORAL CONTRACEPTION CHOLECYSTECTOMY 2
C ORAL CONTRACEPTION CHOLECYSTITIS CHRONIC 4
C ORAL CONTRACEPTION DEEP VEIN THROMBOSIS 2
C ORAL CONTRACEPTION DYSPNOEA 2
C ORAL CONTRACEPTION FEAR 2
C ORAL CONTRACEPTION GALLBLADDER DISORDER 2
C ORAL CONTRACEPTION HEADACHE 2
C ORAL CONTRACEPTION INJURY 4
C ORAL CONTRACEPTION MYOCARDIAL INFARCTION 2
C ORAL CONTRACEPTION PAIN 6
C ORAL CONTRACEPTION PULMONARY EMBOLISM 4
C ORAL CONTRACEPTION SLEEP DISORDER 2
C ORAL CONTRACEPTION WEIGHT INCREASED 2
C PAIN ANXIETY 1
C PAIN BACK PAIN 1
C PAIN BLOOD PRESSURE INCREASED 1
C PAIN CHOLECYSTECTOMY 1
C PAIN CHOLECYSTITIS CHRONIC 1
C PAIN CONTUSION 1
C PAIN DYSPNOEA 1
C PAIN EMOTIONAL DISTRESS 1
C PAIN EPISTAXIS 1
C PAIN HEART RATE INCREASED 1
C PAIN LETHARGY 1
C PAIN PAIN 2
C PAIN PULMONARY EMBOLISM 2
C PAIN THROMBOSIS 1
C PREMENSTRUAL SYNDROME ABDOMINAL PAIN 1
C PREMENSTRUAL SYNDROME ASPARTATE AMINOTRANSFERASE INCREASED 1
C PREMENSTRUAL SYNDROME BACK PAIN 1
C PREMENSTRUAL SYNDROME BLOOD ALKALINE PHOSPHATASE INCREASED 1
C PREMENSTRUAL SYNDROME BLOOD BILIRUBIN INCREASED 1
C PREMENSTRUAL SYNDROME CHOLECYSTECTOMY 2
C PREMENSTRUAL SYNDROME CHOLECYSTITIS 2
C PREMENSTRUAL SYNDROME CHOLECYSTITIS CHRONIC 4
C PREMENSTRUAL SYNDROME CHOLELITHIASIS 1
C PREMENSTRUAL SYNDROME DEHYDRATION 1
C PREMENSTRUAL SYNDROME DRUG DOSE OMISSION 1
C PREMENSTRUAL SYNDROME DUODENITIS 1
C PREMENSTRUAL SYNDROME GALLBLADDER DISORDER 4
C PREMENSTRUAL SYNDROME GALLBLADDER INJURY 2
C PREMENSTRUAL SYNDROME GALLBLADDER OBSTRUCTION 1
C PREMENSTRUAL SYNDROME GASTRIC ULCER 1
C PREMENSTRUAL SYNDROME INJURY 3
C PREMENSTRUAL SYNDROME METRORRHAGIA 1
C PREMENSTRUAL SYNDROME PAIN 3
C PREMENSTRUAL SYNDROME PANCREATITIS 1
C PREMENSTRUAL SYNDROME PEPTIC ULCER 1
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN 4
C PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 5
C PRODUCT USED FOR UNKNOWN INDICATION ARRHYTHMIA 4
C PRODUCT USED FOR UNKNOWN INDICATION BILIARY DYSKINESIA 4
C PRODUCT USED FOR UNKNOWN INDICATION CHEST PAIN 4
C PRODUCT USED FOR UNKNOWN INDICATION EMOTIONAL DISTRESS 5
C PRODUCT USED FOR UNKNOWN INDICATION MENTAL DISORDER 4
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 1
C PRODUCT USED FOR UNKNOWN INDICATION THROMBOSIS 1
C SLEEP DISORDER BILIARY DYSKINESIA 12
C SLEEP DISORDER CEREBROVASCULAR ACCIDENT 12
C SLEEP DISORDER CHOLECYSTITIS CHRONIC 12
C SLEEP DISORDER DEEP VEIN THROMBOSIS 12
C SLEEP DISORDER GALLBLADDER DISORDER 12
C SLEEP DISORDER HEADACHE 12
C SLEEP DISORDER INJURY 12
C SLEEP DISORDER MYOCARDIAL INFARCTION 12
C SLEEP DISORDER PAIN 12
C SLEEP DISORDER PULMONARY EMBOLISM 12
C SLEEP DISORDER SLEEP DISORDER 12
C THROMBOSIS PULMONARY EMBOLISM 1
C THYROID DISORDER DEHYDRATION 1
C THYROID DISORDER GALLBLADDER INJURY 1
C THYROID DISORDER INJURY 1
C THYROID DISORDER PAIN 1
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