ADVIL PEDIATRIC DROPS FEVER FROM COLDS OR FLU

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IBUPROFEN

Disponibil de la:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

Codul ATC:

M01AE01

INN (nume internaţional):

IBUPROFEN

Dozare:

40MG

Forma farmaceutică:

DROPS

Compoziție:

IBUPROFEN 40MG

Calea de administrare:

ORAL

Unități în pachet:

15ML/24ML

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0108883007; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-07-09

Caracteristicilor produsului

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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
.....................