NX 12 HOUR TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

NAPROXEN SODIUM

MAH:

PERRIGO INTERNATIONAL

ATC_code:

M01AE02

INN:

NAPROXEN

dosage:

220MG

pharmaceutical_form:

TABLET

composition:

NAPROXEN SODIUM 220MG

administration_route:

ORAL

units_in_package:

24/50/100/120/200/300 FOR BOTH TABS & CAPL./400(CAPLETS ONLY)

prescription_type:

OTC

therapeutic_area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0113934003; AHFS:

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2021-07-22

SPC

_ _
_NX 12 Hour (naproxen sodium) Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
NX 12 HOUR
Naproxen Sodium Tablets USP
220 mg Tablets and Caplets
Non-steroidal anti-inflammatory drug
Analgesic, Antipyretic
Perrigo
®
International
515 Eastern Ave.
Allegan, MI 49010
USA
Date of Preparation:
January 17, 2012
Submission Control No: 133444
_ _
_NX 12 Hour (naproxen sodium) Product Monograph _
_Page 2 of 32_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 12
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
........................................................................