TEVA-LENOLTEC NO. 4 TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACETAMINOPHEN; CODEINE PHOSPHATE

Available from:

TEVA CANADA LIMITED

ATC code:

N02AJ06

INN (International Name):

CODEINE AND PARACETAMOL

Dosage:

300MG; 60MG

Pharmaceutical form:

TABLET

Composition:

ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 60MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0211376001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-10-05

Summary of Product characteristics

_TEVA-LENOLTEC No. 4 _
_–_
_ Product Monograph_
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
TEVA-LENOLTEC NO. 4
Acetaminophen and codeine phosphate tablets
300 mg acetaminophen and 60 mg codeine phosphate
USP
Analgesic-Antipyretic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9, Canada
www.tevacanada.com
Submission
Control No.:263585
Date of Revision:
May 25, 2022
_TEVA-LENOLTEC No. 4 _
_–_
_ Product Monograph_
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY
PRODUCT
INFORMATION
...........................................................................3
INDICATIONS
AND
CLINICAL
USE.................................................................................3
CONTRAINDICATIONS
....................................................................................................3
WARNINGS
AND
PRECAUTIONS
....................................................................................4
ADVERSE
REACTIONS...................................................................................................
14
DRUG
INTERACTIONS
...................................................................................................
16
DOSAGE
AND
ADMINISTRATION
................................................................................
17
OVERDOSAGE
................................................................................................................
20
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................ 23
STORAGE
AND
STABILITY
...........................................................................................
25
SPECIAL
HANDLING
INSTRUCTIONS
..........................................................................
25
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING .................................................. 25
PART II: SCIENTIFIC INFORMATION
......................................................................