NIGHTTIME PAIN RELIEF CAPSULE
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
11-02-2021
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Werkstoffen:
IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM); DIPHENHYDRAMINE HYDROCHLORIDE
Beschikbaar vanaf:
APOTEX INC
ATC-code:
M01AE51
INN (Algemene Internationale Benaming):
IBUPROFEN, COMBINATIONS
Dosering:
200MG; 25MG
farmaceutische vorm:
CAPSULE
Samenstelling:
IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM) 200MG; DIPHENHYDRAMINE HYDROCHLORIDE 25MG
Toedieningsweg:
ORAL
Eenheden in pakket:
10/20/40/400
Prescription-type:
OTC
Therapeutisch gebied:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0252788001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2014-05-01
Productkenmerken
Page 1 of 46
PRODUCT MONOGRAPH
NIGHTTIME PAIN RELIEF
Ibuprofen and Diphenhydramine Hydrochloride Liquid Gel Capsules
200 mg/25 mg
Manufacturer Standard
ANALGESIC/SLEEP AID
APOTEX INC.
150 SIGNET DRIVE
TORONTO ONTARIO
M9L 1T9
DATE OF INITIAL AUTHORIZATION:
MAY 2, 2014
DATE OF REVISION:
FEBRUARY 11, 2021
SUBMISSION CONTROL NO: 245027
Page 2 of 46
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................
3
CONTRAINDICATIONS
............................................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................................
4
ADVERSE REACTIONS
..........................................................................................................
11
DRUG INTERACTIONS
..........................................................................................................
16
DOSAGE AND ADMINISTRATION
.........................................................................................
20
OVERDOSAGE…………………………………………………………………………………………20
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
22
STORAGE AND STABILITY
....................................................................................................
24
SPECIAL HANDLING
INSTRUCTIONS...................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 25
PART II: SCIENTIFIC INFORMATION
....................................................................................
26
PHARMACEUTICAL INFORMATION
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