Consumer Information for: ADVIL COLD & SINUS CONVENIENCE PACK

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Advil Cold & Sinus Daytime:

For effective temporary relief of the symptoms of colds including sore throat pain, sinus pain, nasal congestion, headache, fever, body aches and pains.

Advil Cold & Sinus Nighttime

Temporarily relieves the combined symptoms associated with colds including: runny nose, sneezing, itchy watery eyes, headache, fever, nasal congestion, minor aches and pains, sore throat, and sinus pain.

What it does

Ibuprofen reduces fever and pain. Pseudoephedrine hydrochloride is a nasal decongestant.
Chlorpheniramine maleate is an antihistamine.

When it should not be used

Do not use either Advil Cold & Sinus Daytime or Advil® Cold & Sinus Nighttime if you have or are:

  • allergic/hypersensitive to acetylsalicylic acid (ASA), ibuprofen, other salicylates, other non-steroidal antiinflammatory drugs (NSAIDs), pseudoephedrine or other sympathomimetic amines, chlorpheniramine maleate, or any of Advil Cold & Sinus Daytime or Advil Cold & Sinus Nighttime’s ingredients (Refer to the non-medicinal ingredients section of this insert),
  • active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis)
  • taking a monoamine oxidase inhibitor (MAOI) or for 14 days after stopping the MAOI drug, ASA, or other NSAIDs including any other ibuprofen product,
  • nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life threatening allergic reaction), urticarial/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergies symptoms,
  • dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake,
  • been diagnosed with severe high blood pressure or have heart disease,
  • right before or after heart surgery,
  • serious liver disease
  • severe kidney disease,
  • high potassium in the blood
  • thyroid disease,
  • Raynaud’s Syndrome (a disorder of the circulatory system),
  • Systemic Lupus Erythematosus,
  • or if you are in your third trimester of pregnancy.
What the medicinal ingredient is

Advil Cold & Sinus Daytime: Ibuprofen and pseudoephedrine hydrochloride
Advil Cold & Sinus Nighttime: Ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate.

What the non-medicinal ingredients are

Advil Cold & Sinus Daytime:
Acetylated monoglycerides, carnauba wax, corn starch, croscarmellose sodium, iron oxides, microcrystalline cellulose, parabens, pharmaceutical ink, povidone, pregelatinized starch, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, titanium dioxide.
Advil Cold & Sinus Nighttime:
Carnauba wax, corn starch, croscarmellose sodium, FD&C red no. 40, FD&C yellow no. 6, glyceryl behenate, hypromellose, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pre-gelatinized starch, silicon dioxide, titanium dioxide.

What dosage form it comes in

Advil Cold & Sinus Daytime:
Each caplet contains ibuprofen 200mg and pseudoephedrine hydrochloride 30mg
Advil Cold & Sinus Nighttime:
Each caplet contains ibuprofen 200mg, pseudoephedrine hydrochloride 30mg and chlorpheniramine maleate 2mg.

Warnings and precautions

Serious Warnings and Precautions

  • If you have diabetes, glaucoma or difficulty in urination due to an enlarged prostate, do not take this drug unless directed by a doctor.
  • Caution in those with heart failure, high blood pressure or other conditions predisposing to fluid retention.
  • Caution in those prone to gastrointestinal tract irritation, including those with a history of peptic ulcer, diverticulosis, or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis or Crohn’s disease. The chance of stomach bleeding is higher if you are: age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner or steroid drug, take with other drugs containing an NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or prescription antiinflammatory drugs, have 3 or more alcoholic drinks every day while using this product.
  • Caution in patients at risk of kidney or liver problems, those taking diuretics and the elderly.
  • Use during pregnancy or nursing should be avoided.
  • Stop use immediately if you have difficulty or pain when urinating.

BEFORE you use either Advil Cold & Sinus Daytime or Advil Cold & Sinus Nighttime talk to your doctor or pharmacist if you have or are:

  • previous or current stomach ulcers,
  • blood clotting disorder (such as hemophilia),
  • breathing problems or chronic lung disease (such as asthma, emphysema or chronic bronchitis),
  • difficulty in urination due to prostate enlargement or bladder neck obstruction,
  • diabetes,
  • high blood pressure,
  • mild to moderate kidney disease,
  • mild to moderate liver disease,
  • heart disease
  • glaucoma,
  • any other serious disease, are under doctor’s care for any serious condition,
  • you are trying to conceive, in your first or second trimester of pregnancy
  • or if you are breastfeeding
  • taking sedatives or tranquilizers (as they may increase drowsiness), or any other drug including over the counter drugs.
  • Use with caution in the elderly.
  • Long-term continuous use may increase the risk of heart attack or stroke.
Interactions with this medication

Do not use this product if you are taking:

  • a MAOI or if you have stopped taking one within the past 2 weeks.
  • ASA or other anti-inflammatory medication.

Drugs that may interact with either Advil Cold & Sinus Daytime or Advil Cold & Sinus Nighttime include:

  • Acetaminophen
  • Acetylsalicylic acid (ASA)
  • Allergy medications
  • Anticoagulants (blood thinning medications)
  • Anti-depressants
  • Anti-hypertensives (blood pressure medications)
  • Antibiotics (levofloxacin)
  • Benzodiazapines
  • Cold medications
  • Corticosteroids
  • Cyclosporine
  • Diabetes medication (including insulin and oral antidiabetic agents)
  • Digoxin
  • Diuretics (water pills)
  • Lithium
  • Methotrexate
  • Monoamine Oxidase Inhibitors
  • Nonsteroidal anti-inflammatory drugs (NSAIDs); including naproxen and ibuprofen
  • Phenytoin
  • Probenecid
  • Thyroxine
  • Tranquilizers or other sedating drugs

Tell your doctor or pharmacist what prescription or nonprescription drugs you are taking or plan to take.

Do not smoke or drink alcohol while using this product. Alcohol may increase drowsiness.

Proper use of this medication

Usual Dose

Adults and children 12 to 65 years: Daytime caplets: Take 1 to 2 beige caplets every 4-6 hours while symptoms persist. Nighttime caplets: Take 1 to 2 orange caplets at bedtime. Do not exceed a combined total of any 6 Advil Cold & Sinus Daytime or Nighttime caplets in 24 hours, unless directed by a doctor.

Do not give to children under 12 unless directed by a doctor. Do not use longer than 3 days for a fever or 5 days for pain relief or cold symptoms.

Overdose

In case of overdose, contact a doctor, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose. Do not take two doses at the same time.

Side effects and what to do about them

Take with food or milk if upset stomach occurs.

Advil Cold & Sinus Daytime and Advil Cold & Sinus Nighttime may occasionally produce unwanted side effects, such as heartburn, constipation, nausea, bloating, dry mouth, nervousness or sleeplessness.

Stop use and contact a doctor or pharmacist if these symptoms worsen or persist.

The risk of having side effects may be decreased by using the smallest dose for the shortest duration of time

Advil Cold & Sinus Nighttime may cause drowsiness. Be careful when driving motor vehicles or operating heavy machinery

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Uncommon
Symptoms of allergic reaction, including: rash, severe itching/ redness, blisters, swelling, or trouble breathing     ✔
Blood in vomit, bloody or black stools     ✔
Abdominal pain, vomiting, diarrhea   ✔  
Ringing or buzzing in the ears / dizziness   ✔  
Change in vision   ✔  
Fluid retention     ✔

This is not a complete list of side effects. For any unexpected effects while taking Advil Cold & Sinus Daytime or Advil Cold & Sinus Nighttime, contact your doctor or pharmacist.

How to store

Store at room temperature (15°C – 30°C).

Keep out of reach of children. This package contains enough medicine to seriously harm a child.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor GlaxoSmithKline Consumer Healthcare Inc.., Mississauga, Ontario L5N 6L4 at: 1-888-275-9938 or www.advil.ca.

This leaflet was prepared by GlaxoSmithKline Consumer Healthcare Inc..

Product monograph available to doctors and pharmacists upon request.

Last revised: 27 October 2020

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