PAIN RELIEVER & SLEEP AID TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-09-2020
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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Available from:
APOTEX INC
ATC code:
M01AE57
INN (International Name):
NAPROXEN AND DIPHENHYDRAMINE
Dosage:
25MG; 220MG
Pharmaceutical form:
TABLET
Composition:
DIPHENHYDRAMINE HYDROCHLORIDE 25MG; NAPROXEN SODIUM 220MG
Administration route:
ORAL
Units in package:
100
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0257270001; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-10-08
Summary of Product characteristics
Page 1 of 47
PRODUCT MONOGRAPH
PAIN RELIEVER & SLEEP AID
Naproxen Sodium 220 mg and Diphenhydramine Hydrochloride 25mg Tablets
Apotex Inc.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Preparation:
September 30, 2020
Control No. 230683
Page 2 of 47
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
.................................................................................................
3
CONTRAINDICATIONS
............................................................................................................................
3
WARNINGS AND PRECAUTIONS
...........................................................................................................
4
ADVERSE REACTIONS
.............................................................................................................................
7
DRUG INTERACTIONS
...........................................................................................................................
12
DOSAGE AND ADMINISTRATION
.......................................................................................................
14
OVERDOSAGE...........................................................................................................................................
15
ACTION AND CLINICAL
PHARMACOLOGY......................................................................................
15
STORAGE AND STABILITY
...................................................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
18
PART II: SCIENTIFIC INFORMATION
.............................................................................................
20
PHARMACEUTICAL INFORMATION
........
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