PRODUCT MONOGRAPH

PRODUCT MONOGRAPH

ADVIL COLD & FLU

ADVIL PAIN & HEAD COLD NIGHT

Ibuprofen and Diphenhydramine Citrate Caplets

200 mg/38 mg

Analgesic/Antipyretic and Antihistamine

Pfizer Consumer Healthcare, a division of Pfizer Canada

ULC

450-55 Standish Court

Mississauga, Ontario

Canada L5R 4B2

Date of Revision:

October 16, 2019

Submission Control No.: 231035

Pfizer Consumer Healthcare, a division of Pfizer Canada ULC

Page 1 of 54

Table of Contents

PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3

SUMMARY PRODUCT INFORMATION ........................................................................3

INDICATIONS AND CLINICAL USE ..............................................................................3

CONTRAINDICATIONS ...................................................................................................3

ADVERSE REACTIONS ..................................................................................................12

DOSAGE AND ADMINISTRATION ..............................................................................22

OVERDOSAGE ................................................................................................................23

ACTION AND CLINICAL PHARMACOLOGY ............................................................24

STORAGE AND STABILITY ..........................................................................................28

SPECIAL HANDLING INSTRUCTIONS .......................................................................28

DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................28

PART II: SCIENTIFIC INFORMATION ...............................................................................29

PHARMACEUTICAL INFORMATION ..........................................................................29

CLINICAL TRIALS ..........................................................................................................31

DETAILED PHARMACOLOGY .....................................................................................34

MICROBIOLOGY ............................................................................................................35

TOXICOLOGY .................................................................................................................36

REFERENCES ..................................................................................................................39

PART III: CONSUMER INFORMATION..............................................................................49

Pfizer Consumer Healthcare, a division of Pfizer Canada ULC

Page 2 of 54

ADVIL COLD & FLU

ADVIL PAIN & HEAD COLD NIGHT

Ibuprofen and Diphenhydramine Citrate Caplets

PART I: HEALTH PROFESSIONAL INFORMATION

SUMMARY PRODUCT INFORMATION

Route of Administration

Dosage Form / Strength

Oral

Caplet:

ibuprofen 200 mg,

diphenhydramine citrate 38

mg

Clinically Relevant

Nonmedicinal Ingredients

None.

For a complete listing see

Dosage Forms, Composition

and Packaging section.

INDICATIONS AND CLINICAL USE

Advil? Cold & Flu and Advil? Pain & Head Cold Night (ibuprofen and diphenhydramine citrate

caplets) are indicated for the relief of cold and influenza symptoms including: Body aches and

pains, sore throat pain, fever, headache, runny nose, sneezing and itchy watery eyes.

Geriatrics (>65 years of age):

Evidence from clinical studies and experience suggests that use in the geriatric population is

associated with differences in safety or effectiveness. Therefore the use of Advil? Cold & Flu or

Advil? Pain & Head Cold Night in this population is not recommended. (See Warnings and

Precautions, Special Populations, Geriatrics) [138].

Pediatrics ( ................
................

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