IBUPROFEN DAYTIME, IBUPROFEN NIGHTTIME CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM); IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM)

Dostopno od:

VITA HEALTH PRODUCTS INC

Koda artikla:

M01AE51

INN (mednarodno ime):

IBUPROFEN, COMBINATIONS

Odmerek:

25MG; 200MG; 200MG

Farmacevtska oblika:

CAPSULE

Sestava:

DIPHENHYDRAMINE HYDROCHLORIDE 25MG; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM) 200MG; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM) 200MG

Pot uporabe:

ORAL

Enote v paketu:

DAYTIME 12/24 - NIGHTTIME 6/12

Tip zastaranja:

OTC

Terapevtsko območje:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0354570001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2015-02-16

Lastnosti izdelka

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_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
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_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
..............................