Consumer Information for: COLD & SINUS RELIEF CAPSULES

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

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

What it does

Ibuprofen reduces pain and fever. Pseudoephedrine hydrochloride is a nasal decongestant.

When it should not be used

Do not use COLD & SINUS RELIEF CAPSULES if you have or are:

  • allergic/hypersensitive to acetylsalicylic acid (ASA), ibuprofen, other salicylates, other NSAIDs, pseudoephedrine or other sympathomimetic amines or any of COLD & SINUS RELIEF CAPSULES ingredients (Refer to the nonmedicinal ingredients section of this insert),
  • active or recurrent stomach ulcer or gastrointestinal bleeding or active inflammatory bow el disease (e.g. Crohn’s, colitis),
  • taking a monoamine oxidase inhibitor (MAOI; e.g. drugs for depression or Parkinson’s disease) or for 14 days after stopping the MAOI drug, ASA or other NSAIDs including any other ibuprofen product,
  • nasal polyps (sw elling of the inside of the nose),
  • asthma,
  • allergic manifestations such as anaphylaxis (sudden severe life threatening allergic reaction), urticaria/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 w ith severe high blood pressure or have heart disease,
  • right before or after heart surgery,
  • serious liver disease,
  • severe kidney disease,
  • 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

Ibuprofen and pseudoephedrine hydrochloride

What the non-medicinal ingredients are

D&C Yellow no.10, FD&C Red no.40, gelatin, polyethylene glycol, potassium hydroxide, propylene glycol, and sorbitol sorbitan solution.

The sorbitol sorbitan solution contains sorbitan, sorbitol, mannitol and high polychains.

The capsule shells imprinted w ith black edible ink contains hypromellose, iron oxide black and propylene glycol.

What dosage form it comes in

Each capsule contains ibuprofen 200 mg and pseudoephedrine hydrochloride 30 mg.

Warnings and precautions

Serious Warnings and Precautions

  • If you have glaucoma or difficulty in urination due to an enlarged prostate, do not take this drug unless directed by a doctor.
  • Caution in those w ith heart failure, high blood pressure or other conditions that may cause excess fluid collecting in tissues.
  • Caution in patients at risk of gastrointestinal tract irritation, including those w ith a history of a peptic ulcer. 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 w ith other drugs containing an NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or prescription anti-inflammatory drugs, have 3 or more alcoholic drinks every day w hile using this product.
  • Caution in patients at risk of kidney problems, including the elderly or those using diuretics.
  • Use during pregnancy or nursing should be avoided.
  • Stop use immediately if you have difficulty or pain w hen urinating.

BEFORE you use COLD & SINUS RELIEF CAPSULES talk to your doctor or pharmacist if you have:

  • blood clotting disorder (such as hemophilia),
  • breathing problems or chronic lung disease (such as chronic bronchitis),
  • diabetes,
  • difficulty in urination due to prostate enlargement,
  • glaucoma,
  • high blood pressure,
  • mild to moderate kidney disease,
  • mild to moderate liver disease,
  • 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 or are taking any other drug including over the counter drugs.
Interactions with this medication

Do not use this product if you are taking:

  • a MAOI or if you have stopped taking one w ithin the past tw o w eeks.
  • ASA or other anti-inflammatory or pain medication.

Drugs that may interact w ith COLD & SINUS RELIEF CAPSULES include:

  • Acetaminophen
  • acetylsalicylic acid (ASA),
  • allergy medications,
  • anticoagulants (blood thinning medications),
  • antidepressants,
  • anti-hypertensives (blood pressure medications),
  • antibiotics (levofloxacin),
  • benzodiazapines,
  • cold medications,
  • corticosteroids,
  • cyclosporine,
  • diabetes medication (including insulin and oral antidiabetic agents),
  • digoxin,
  • diuretics (w ater pills),
  • lithium,
  • methotrexate,
  • monoamine Oxidase Inhibitors,
  • nonsteroidal anti-inflammatory drugs (NSAIDs); including naproxen and ibuprofen,
  • phenytoin
  • probenecid
  • thyroxine

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

Do not smoke or drink alcohol w hile using this product.

Proper use of this medication

Usual Dose

Adults and children 12 to 65 years: Take 1 or 2 capsules every 4 to 6 hours as needed. Do not exceed 6 capsules in 24 hours, unless directed by a doctor.

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

Overdose

If you think you have taken too much COLD & SINUS RELIEF CAPSULES, contact your healthcare professional, hospital emergency department or regional poison control center immediately, even if there are no symptoms.

Missed Dose

Continue to take 1 or 2 capsules every 4 to 6 hours as needed after a missed dose. Do not take tw ice the recommended dose follow ing a missed dose.

Side effects and what to do about them

Take w ith food or milk if upset stomach occurs. COLD & SINUS RELIEF CAPSULES may occasionally produce unw anted side effects, such as heartburn, constipation, nausea, bloating, nervousness or sleeplessness.

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

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

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN 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, sw elling, 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 COLD & SINUS RELIEF CAPSULES, contact your doctor or pharmacist.

How to store

Store at room temperature 15°C to 30°C.

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

Reporting side effects

Reporting Side Effects

You can report any suspected side effects associated w ith 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

If you want more information about COLD & SINUS RELIEF CAPSULES:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada w ebsite (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s w ebsite http://www.apotex.ca/products, or by calling 1-800-667-4708.

This leaflet w as prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Report a problem or mistake on this page
Please select all that apply:
Date modified: