EXDOL-30 TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACETAMINOPHEN; CAFFEINE CITRATE; CODEINE PHOSPHATE

Available from:

PHARMASCIENCE INC

ATC code:

N02AJ06

INN (International Name):

CODEINE AND PARACETAMOL

Dosage:

300MG; 30MG; 30MG

Pharmaceutical form:

TABLET

Composition:

ACETAMINOPHEN 300MG; CAFFEINE CITRATE 30MG; CODEINE PHOSPHATE 30MG

Administration route:

ORAL

Units in package:

500

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0302037004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-07-14

Summary of Product characteristics

PRESCRIBING INFORMATION
N
EXDOL-8
®
ACETAMINOPHEN (300 MG), CAFFEINE CITRATE (30 MG), CODEINE PHOSPHATE (8
MG) TABLETS
N
EXDOL-15
®
ACETAMINOPHEN (300 MG), CAFFEINE CITRATE (30 MG), CODEINE PHOSPHATE
(15 MG) TABLETS
N
EXDOL-30
®
ACETAMINOPHEN (300 MG), CAFFEINE CITRATE (30 MG), CODEINE PHOSPHATE
(30 MG) TABLETS
ANALGESIC - ANTIPYRETIC
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite #100
Montréal, Québec
H4P 2T4
Date of Revision:
March 25, 2014
www.pharmascience.com
Submission Control: 172010
®
EXDOL-8, EXDOL-15 and EXDOL-30 are registered trademarks of
Pharmascience Inc.
_EXDOL-8, EXDOL-15 _

_ EXDOL-30 Prescribing Information _
_Page 2 of 9_
PRESCRIBING INFORMATION
N
EXDOL-8
ACETAMINOPHEN (300 MG), CAFFEINE CITRATE (30 MG), CODEINE PHOSPHATE (8
MG), TABLETS
N
EXDOL-15
ACETAMINOPHEN (300 MG), CAFFEINE CITRATE (30 MG), CODEINE PHOSPHATE
(15 MG), TABLETS
N
EXDOL-30
ACETAMINOPHEN (300 MG), CAFFEINE CITRATE (30 MG), CODEINE PHOSPHATE
(30 MG), TABLETS
ANALGESIC - ANTIPYRETIC
INDICATIONS
For the relief of mild to moderate pain and the reduction of fever in
adults 18 years and older.
CLINICAL USES
EXDOL is valuable as a non-salicylate analgesic for the relief of pain
in a wide variety of arthritic
and
rheumatic
conditions
involving
musculoskeletal
pain
as
well
as
in
myalgia,
neuralgia,
headache, toothache and dysmenorrhea; as an antipyretic for
symptomatic reduction of fever.
EXDOL is particularly useful for patients who must avoid the gastric
irritation caused by
acetylsalicylic acid (such as patients with peptic ulcer, gastritis,
hiatus hernia, reflux esophagitis
and patients on steroid therapy); for patients allergic to
acetylsalicylic acid; for patients with
bleeding disorders or on anticoagulant therapy.
PEDIATRICS
Regardless of clinical setting, the use of codeine, including EXDOL,
is not recommended in
patients below the age of 18 years due to increased safety concerns.
_EXDOL-8, EXDOL-15 _

_ EXDOL-30 Prescribing Information _
_Page 3 of 9_
CONTRAINDICATIONS
Sensitivity to any of the components.
Repea