Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
M01AE51
IBUPROFEN, COMBINATIONS
200MG; 30MG; 2MG
TABLET
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; CHLORPHENIRAMINE MALEATE 2MG
ORAL
15G/50G
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0349765001; AHFS:
APPROVED
2010-12-08
_GlaxoSmithKline Consumer Healthcare Inc. _ _ _ _Page 1_ _ of 86_ PRODUCT MONOGRAPH ADVIL COLD & SINUS PLUS Ibuprofen, Pseudoephedrine Hydrochloride and Chlorpheniramine Maleate Caplets 200 mg/30 mg/2 mg ADVIL COLD, SINUS & FLU EXTRA STRENGTH Ibuprofen, Pseudoephedrine Hydrochloride and Chlorpheniramine Maleate Caplets 400 mg/60 mg/4 mg CHILDREN’S ADVIL COLD & FLU MULTI-SYMPTOM Ibuprofen, Pseudoephedrine Hydrochloride and Chlorpheniramine Maleate Suspension 100 mg/15 mg/1 mg per 5 mL Analgesic/Antipyretic/Nasal Decongestant/Antihistamine GlaxoSmithKline Consumer Healthcare Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Date of Preparation: April 3, 2020 Submission Control No.:237125 _GlaxoSmithKline Consumer Healthcare Inc. _ _ _ _Page 2_ _ of 86_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................6 ADVERSE REACTIONS ..................................................................................................14 DRUG INTERACTIONS ..................................................................................................26 DOSAGE AND ADMINISTRATION ..............................................................................31 OVERDOSAGE ................................................................................................................32 ACTION AND CLINICAL PHARMACOLOGY ............................................................35 STORAGE AND STABILITY ..........................................................................................40 SPECIAL HANDLING INSTRUCTIONS ........... Izlasiet visu dokumentu