TRIATEC-30 TABLET

Country: Canada

Language: English

Source: Health Canada

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Active ingredient:

ACETAMINOPHEN; CODEINE PHOSPHATE

Available from:

LABORATOIRE RIVA INC.

ATC code:

N02AJ06

INN (International Name):

CODEINE AND PARACETAMOL

Dosage:

300MG; 30MG

Pharmaceutical form:

TABLET

Composition:

ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 30MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0211376003; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-10-14

Summary of Product characteristics

                                _TRIATEC-30_
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_Page 1 of 39_
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PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N TRIATEC-30
Acetaminophen and Codeine Phosphate Tablets USP
300 mg/30 mg
Analgesic – Antipyretic – Antitussive
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Canada
J7C 3V4
www.labriva.com
Control No: 236196
Date of Revision:
February 26, 2020
_TRIATEC-30_
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_Page 2 of 39_
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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
................................................................................................
17
DRUG INTERACTIONS
................................................................................................
18
DOSAGE AND ADMINISTRATION
............................................................................
21
OVERDOSAGE
..............................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 25
STORAGE AND STABILITY
........................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 27
PART II: SCIENTIFIC INFORMATION
..............................................................................
28
PHARMACEUTICAL INFORMATION
........................................................................
28
REFERENCES
.............................................................................................
                                
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