Cold & Sinus Relief Capsules: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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 ingredients are:

Ibuprofen and pseudoephedrine hydrochloride.

What the nonmedicinal 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 forms it comes in:

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

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

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 non-prescription 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:

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.

This is not a complete list of side effects. For any unexpected effects while taking COLD & SINUS RELIEF CAPSULES, contact your doctor or pharmacist.

Reporting Side Effects

HOW TO STORE IT

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.

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://w w w.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: May 18, 2021