CHILDREN'S ADVIL SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IBUPROFEN

Available from:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC code:

M01AE01

INN (International Name):

IBUPROFEN

Dosage:

100MG

Pharmaceutical form:

SUSPENSION

Composition:

IBUPROFEN 100MG

Administration route:

ORAL

Units in package:

60ML/100ML

Prescription type:

OTC

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0108883005; AHFS:

Authorization status:

APPROVED

Authorization date:

2004-12-01

Summary of Product characteristics

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_GlaxoSmithKline Consumer Healthcare ULC. _
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_Page 1 of 56_
PRODUCT MONOGRAPH
CHILDREN’S ADVIL
 CHEWABLE TABLETS
Ibuprofen Tablets USP, 50 mg
CHILDREN’S ADVIL

CHILDREN’S ADVIL
 FEVER FROM COLDS OR FLU
Ibuprofen 100 mg/5 mL
Ibuprofen Oral Suspension, USP
JUNIOR STRENGTH ADVIL

JUNIOR STRENGTH ADVIL
 FEVER FROM COLDS OR FLU
Ibuprofen Tablets USP, 100 mg
ADVIL
 PEDIATRIC DROPS
ADVIL
 PEDIATRIC DROPS FEVER FROM COLDS OR FLU
Ibuprofen 40 mg/mL
Ibuprofen Oral Suspension, USP
Analgesic/Antipyretic
GlaxoSmithKline Consumer Healthcare ULC
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
July 20, 2006
Date of Revision:
March 12, 2021
Submission Control No: 244560
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_GlaxoSmithKline Consumer Healthcare ULC _
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_Page 2 of 56_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
4
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
6
ADVERSE REACTIONS
..............................................................................................
13
DRUG INTERACTIONS
..............................................................................................
17
DOSAGE AND ADMINISTRATION
...........................................................................
20
OVERDOSAGE
............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 24
STORAGE AND STABILITY
......................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
.....................