Cold + Sinus Nighttime: Uses, Side Effects and Dosage

What the medication is used for:

Temporarily relieves the combined symptoms associated with colds including: stuffy nose, fever, minor body aches, sore throat, headache, runny nose, sneezing, itchy, watery eyes 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 Cold + Sinus Nighttime if you have or are:

• active or recurrent stomach ulcer or

  gastrointestinal (GI) bleeding or active inflammatory bowel disease (e.g. Crohn's, colitis),

• taking a monoamine oxidase inhibitor

  (MAOI; e.g. drug for depression or Parkinson's disease) or for 14 days after stopping the MAOI drug, acetylsalicylic acid (ASA), or other non-steroidal anti-inflammatory drugs (NSAIDs) including any other ibuprofen product,

• allergic/hypersensitive to ASA, ibuprofen,

  other salicylates, other NSAIDs, pseudoephedrine or other sympathomimetic amines, chlorpheniramine maleate, or any of Cold + Sinus Nighttime ingredients (Refer to the nonmedicinal ingredients section of this insert),

• nasal polyps (swelling 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 with severe high blood pressure or have heart disease,
  • about to have or just had heart surgery,
  • serious liver disease,
  • severe kidney disease,
  • thyroid disease,
  • Raynaud’s Syndrome (a disorder of the circulatory system),
  • Systemic Lupus Erythematosus,

  • Pregnant or nursing.

What the medicinal ingredients are:

Ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate.

What the important nonmedicinal ingredients are:

Corn starch, colloidal silicon dioxide, croscarmellose sodium, FD&C yellow no. 6, FD&C red no. 40, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide.

What dosage forms it comes in:

Each Tablet contains ibuprofen 200 mg, pseudoephedrine hydrochloride 30 mg and chlorpheniramine maleate 2 mg.

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.
• Use during pregnancy or nursing should be avoided.
• Stop use immediately if you have difficulty or pain when urinating.

BEFORE you use Cold + Sinus Nighttime talk to your doctor or pharmacist if you have or are:

• 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

• taking sedatives or tranquilizers (as they may

  increase drowsiness), or any other drug including over the counter drugs.

Do not use this product if you are taking:

• a MAOI or if you have stopped taking one within

  the past 2 weeks.

• Daily low dose ASA (81 - 325 mg), without

  talking to a doctor or pharmacist. Ibuprofen may interfere with the preventative benefits of ASA.

• other anti-inflammatory medication.

Drugs that may interact with Cold + Sinus Nighttime include:

• Acetaminophen
• Acetylsalicylic Acid (ASA)
• Allergy medications
• Anticoagulants (blood thinning medications)
• Anti-depressants
• Anti-hypertensives (blood pressure medications)
• Antibiotics (levofloxacin)
• Benzodiazepines
• Cold medications
• Corticosteroids
• Cyclosporine

• Diabetes medications (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 non-prescription drugs you are taking or plan to take.

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

Usual dose:

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

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

Overdose:

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

Missed Dose:

Continue to take 1 or 2 tablets every 4-6 hours as needed after a missed dose. Do not take twice the recommended dose following a missed dose.

Cold + Sinus Nighttime may cause drowsiness. Do not drive or engage in activities requiring alertness.

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.

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

Store in tightly closed containers at room temperature (15°-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:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-

  products/medeffect-canada.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Vita Health Products Inc., 150 Beghin Avenue, Winnipeg, MB R2J 3W2 1-800-665-8820

Product monograph available to physicians and pharmacists upon request.

Last revised: July 12, 2018