Land: Canada
Sprog: engelsk
Kilde: Health Canada
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM); IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM)
VITA HEALTH PRODUCTS INC
M01AE51
IBUPROFEN, COMBINATIONS
25MG; 200MG; 200MG
CAPSULE
DIPHENHYDRAMINE HYDROCHLORIDE 25MG; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM) 200MG; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM) 200MG
ORAL
DAYTIME 12/24 - NIGHTTIME 6/12
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0354570001; AHFS:
APPROVED
2015-02-16
_ _ _ _ _Page 1 of 61_ PRODUCT MONOGRAPH IBUPROFEN DAYTIME, IBUPROFEN NIGHTTIME (DAY/NIGHT CONVENIENCE PACK) IBUPROFEN DAYTIME Ibuprofen Liquid Capsules 200 mg (free acid and potassium salt) Analgesic IBUPROFEN NIGHTTIME Ibuprofen and Diphenhydramine Hydrochloride Liquid Gel Capsules Ibuprofen 200 mg (free acid and potassium salt) and Diphenhydramine Hydrochloride 25 mg Analgesic/Sleep Aid Vita Health Products Inc. 150 Beghin Avenue Winnipeg Manitoba Canada, R2J 3W2 Submission Control No. 180118 Date of Preparation: January 30, 2015 _ _ _ _ _Page 2 of 61_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................. 12 DRUG INTERACTIONS ................................................................................................. 19 DOSAGE AND ADMINISTRATION ............................................................................. 23 OVERDOSAGE ............................................................................................................... 25 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 26 STORAGE AND STABILITY ......................................................................................... 29 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 29 PART II: SCIENTIFIC INFORMATION .............................................................................. 31 CLINICAL TRIALS .............................. Læs hele dokumentet