Advil Cold & Sinus Pe: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Advil® Cold & Sinus PE provides fast, effective, temporary relief of symptoms associated with the common cold including nasal congestion, headache, fever, sinus pain, and minor body aches and pains.

What it does:

Advil® (ibuprofen) reduces pain and fever.

Phenylephrine hydrochloride is a nasal decongestant.

When it should not be used:

Do not take Advil® Cold & Sinus PE if you have or are:

• allergic/hypersensitive to acetylsalicylic acid

  (ASA), ibuprofen, other salicylates, other non-steroidal anti-inflammatory drugs (NSAIDs), phenylephrine hydrochloride or other sympathomimetic amines or any ingredient in the formulation or component of the container (Refer to the nonmedicinal ingredients section of this insert),

• active peptic ulcer, a history of recurrent

  ulceration or active gastrointestinal bleeding,

• 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),
• asthma,

• allergic manifestations such as anaphylaxis

  (sudden severe life threatening allergic reaction), uticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic 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,

• about to have or just had heart surgery,

• serious liver disease,

  • severe kidney disease,
  • inflammatory bowel disease such as ulcerative colitis or Crohn’s disease,
  • Raynaud’s Syndrome (a disorder of the circulatory system),
  • Sytemic Lupus Erythematosus,

  • pregnant or nursing.

What the medicinal ingredients are:

Ibuprofen and phenylephrine hydrochloride.

What the important non medicinal ingredients are: acesulfame potassium, carboxymethylcellulose sodium, corn starch, croscarmellose sodium, dextrose monohydrate, flavour, hypromellose, iron oxides, lecithin, maltodextrin, medium chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, stearic acid, sucralose, talc, titanium dioxide and xanthan gum.

What dosage forms it comes in:

Advil® Cold & Sinus PE caplets contain 200 mg ibuprofen and phenylephrine hydrochloride 5 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Caution in patients at risk of gastrointestinal tract irritation,
• Patients at risk of kidney problems, including the elderly or those using diuretics.
• Stop use immediately if you have difficulty or pain when urinating.

BEFORE you use Advil® Cold & Sinus PE, talk to your doctor or pharmacist if you have or have had any of the following:

• blood clotting disorder (such as hemophilia)
• breathing problems or chronic lung disease (such as chronic bronchitis)
• diabetes,
• depression,
• itchy skin or hives
• high blood pressure
• history of gastrointestinal illness
• difficulty in urination due to enlargement of the prostate gland,
• glaucoma
• mild to moderate kidney disease
• mild to moderate liver disease
• thyroid disease,
• any other serious disease, are under doctor’s care for

any serious condition, or are taking any other drug including nonprescription (over the counter) drugs. Do not use for longer than 3 days for a fever or for 5 days for pain/cold symptoms.

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 two weeks.
• ASA or other anti-inflammatory medication.

Before you use Advil® Cold & Sinus PE, talk to your doctor or pharmacist if you are taking any other drug, especially:

• Acetaminophen
• Acetylsalicylic acid (ASA)
• Allergy medications
• Anticoagulants (blood thinning medications)
• Antidepressants
• Anti-hypertensives (blood pressure medications)
• Antibiotics (levofloxacin)
• Asthma medications (sympathomimetic agents)
• Benzodiazapenes
• Cold medications
• Cyclosporine

• Diabetes medication (including insulin and oral

  antidiabetic agents)

• Digoxin
• Diuretics (water pills)
• Epinephrine or norepinephrine
• Glucocorticoids (oral steroids)
• Lithium
• Methotrexate
• Monoamine Oxidase Inhibitors

• Nonsteroidal anti-inflammatory drugs

  (NSAIDs); including naproxen and ibuprofen

• Phenytoin
• Probenecid
• Thyroxine

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

Do not smoke or drink alcohol while using this product.

PROPER USE OF THIS MEDICATION

Usual dose:

Adults 65 and under and Children over 12 years: Take 2 caplets every 4 hours as needed. Do not exceed six caplets in 24 hours, unless directed by a physician.

Children 12 years and under: Do not use.

Take with food or milk if stomach upset occurs.

Stop use and call your doctor if fever persists for more than 3 days or pain/cold symptoms last for more than 5 days.

Overdose:

Missed Dose:

Continue to take this product according to the directions as needed, after a missed dose. Do not take twice the recommended dose following a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Advil® Cold & Sinus PE may occasionally produce unwanted side effects, such as heartburn, constipation, nausea, bloating, nervousness or sleeplessness.

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

In case of accidental overdose, call a Poison Control Centre or a doctor immediately, even if there are no symptoms.

Ibuprofen may cause a severe allergic reaction that could include wheezing, facial swelling, hives, shortness of breath, shock, or a fast irregular heartbeat. Any of these reactions could be serious. Stop using the product and get emergency medical help immediately.

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

HOW TO STORE IT

Store at room temperature (15°-30°C). Protect from moisture and excessive heat.

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

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor,

, Mississauga, ON L5N 6L4at: 1-888-275-9938 or www.advil.ca.

Product monograph available to physicians and pharmacists upon request.

Last revised: 06-July-2020

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

$ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701D

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.