Consumer Information for: COLD + SINUS DAYTIME COLD + SINUS NIGHTTIME

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

Cold + Sinus Nighttime

Temporarily relieves the combined symptoms associated with colds including: stuffy nose, fever, minor body aches, sore throat, headache, runny nose, sneezing, itchy, water eyes and sinus pain.

Cold + Sinus Daytime

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

What it does

Cold + Sinus Nighttime

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

Cold + Sinus Daytime

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

When it should not be used

Cold + Sinus Nighttime

Do not use Cold + Sinus Nighttime if you have or are:

  • allergic/hypersensitive to acetylsalicylic acid (ASA), ibuprofen, other salicylates, other non-steroidal anti-inflammatory drugs (NSAIDs), pseudoephedrine or other sympathomimetic amines, chlorpheniramine maleate, or any of Cold + Sinus Nighttime ingredients (Refer to the nonmedicinal ingredients section of this insert),
  • peptic ulcer disease or 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,
  • thyroid disease,
  • Raynaud’s Syndrome (a disorder of the circulatory system),
  • Systemic Lupus Erythematosus,
  • Pregnant or nursing.

Cold + Sinus Daytime

Do not use Cold + Sinus Daytime if you have or are:

  • allergic/hypersensitive to acetylsalicylic acid (ASA), ibuprofen, other salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs), pseudoephedrine or other sympathomimetic aminesor any of Cold + Sinus Daytime ingredients (Refer to the nonmedicinal ingredients section of this insert),
  • peptic ulcer disease or 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,
  • thyroid disease,
  • Raynaud’s Syndrome (a disorder of the circulatory system),
  • Systemic Lupus Erythematosus,
  • pregnant or nursing.
What the medicinal ingredient is

Cold + Sinus Nighttime

Ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate.

Cold + Sinus Daytime

Ibuprofen and pseudoephedrine hydrochloride.

What the non-medicinal ingredients are

Cold + Sinus Nighttime

Corn starch, colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6, FD&C red#40, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide.

Cold + Sinus Daytime

Colloidal silicon dioxide, croscarmellose sodium, iron oxide red, iron oxide yellow, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, talc, titanium dioxide, xanthan gum.

What dosage form it comes in

Cold + Sinus Nighttime

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

Cold + Sinus Daytime

Each caplet contains ibuprofen 200 mg, pseudoephedrine hydrochloride 30 mg.

Warnings and precautions

Cold + Sinus Nighttime

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.

Cold + Sinus Daytime

Serious Warnings and Precautions

  • Cation 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 Daytime 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, or are taking any other drug including over the counter drugs.
Interactions with this medication

Cold + Sinus Nighttime

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 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 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.

Cold + Sinus Daytime

Do not use this product if you are taking:

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

Drugs that may interact with Cold + Sinus Daytime 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 (water pills)
  • 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 nonprescription drugs you are taking or plan to take.

Do not smoke or drink alcohol while using this product.

Proper use of this medication

Cold + Sinus Nighttime

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 Daytime

Usual Dose

Adults under 65 years and children over 12: Take 1 or 2 caplets every 4 to 6 hours as needed. Do not exceed six caplets in 24 hours, unless directed by a physician.
Do not give to children under 12 unless directed by physician. Do not use longer than 3 days for a fever or 5 days for pain or cold symptoms.

Overdose

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

Missed Dose

Continue to take 1 or 2 caplets every 4 hours 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

Cold + Sinus Nighttime

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.

The risk of having side effect 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 with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Seek immediate emergency medical assistance
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 product may cause drowsiness. Be careful when driving motor vehicles or operating heavy machinery.

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

Cold + Sinus Daytime

Cold + Sinus Daytime 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.

The risk of having side effect 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 with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Seek immediate emergency medical assistance
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 Cold + Sinus Daytime, contact your doctor or pharmacist.

Reporting 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:

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

How to store

Cold + Sinus Nighttime

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.

Cold + Sinus Daytime

Store in tightly closed containers at room temperature (15-30°C). Keep out of the reach of children. This package contains enough medicine 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, Vita Health Products Inc., 150 Beghin Avenue, Winnipeg, MB R2J 3W2, at: 1-800-665-8820.

This leaflet was prepared by Vita Health Products Inc.
Product monograph available to physicians and pharmacists upon request.

Date of Revision: October 31, 2011

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