Patient Medication Information: uses, side effects, how to take - Motrin Cold & Sinus Caplets
ABOUT THIS MEDICATION
What the medication is used for:
MOTRIN COLD & SINUS (ibuprofen/pseudoephedrine hydrochloride) acts quickly to provide effective relief of symptoms associated with sinusitis (inflammation of the sinuses), the common cold or flu including:
- Nasal Congestion
- Sinus Pressure
- Sinus Pain
- Fever
- Body Aches & Pains
- Headache
What it does:
MOTRIN COLD & SINUS caplets have a combination of two medicinal ingredients – ibuprofen and pseudoephedrine hydrochloride. Ibuprofen is an analgesic and antipyretic that acts quickly to relieve pain and fever. Pseudoephedrine hydrochloride is a decongestant which helps relieve nasal congestion.
When it should not be used:
MOTRIN* COLD & SINUS should not be used by children under 12 years of age, except as directed by a doctor.
Do not take this product while taking acetylsalicylic acid (ASA), other non-steroidal anti-inflammatory medication (NSAIDs), other ibuprofen-containing products or any other pain or fever medicine.
Do not take this product if you are allergic to ibuprofen, to any MOTRIN* Cold & Sinus nonmedicinal ingredients (see list on carton) or to products containing ASA, other salicylates or other anti-inflammatory drugs or if you have ASA-sensitive asthma. Ibuprofen may cause a severe allergic reaction that could include facial swelling, hives, wheezing, shortness of breath, shock or a fast, irregular heartbeat. Any of these reactions could be serious. Stop using this product and get emergency medical help immediately.
Do not use MOTRIN* Cold & Sinus if you have liver, heart or kidney disease, high blood pressure, hyperkalemia (excess potassium in your blood), systemic Lupus Erythematosus, a
stomach or intestinal ulcer, an inflammatory disease of the gastrointestinal tract or if you have suffered significant fluid loss (i.e. diarrhea, dehydration).
Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease) or for 2 weeks after stopping an MAOI drug. If you are uncertain if your prescription drug contains an MAOI, talk to a doctor before taking this product.
What the medicinal ingredient is:
MOTRIN* COLD & SINUS caplets contain two medicinal ingredients, ibuprofen and pseudoephedrine hydrochloride.
What the important nonmedicinal ingredients are: carnauba wax, cellulose, colloidal silicon dioxide, corn starch, FD&C red no. 40, hypromellose, propylene glycol, sodium lauryl sulphate, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.
What dosage forms it comes in:
MOTRIN* COLD & SINUS are available in caplets which contain 200 mg ibuprofen, and 30 mg pseudoephedrine hydrochloride.
WARNINGS AND PRECAUTIONS
Talk to a doctor before use if you have:
- peptic ulcers or a history of peptic ulcers, a history of stomach bleeding or other bleeding problems or gastrointestinal tract irritation or if you are prone to gastrointestinal tract irritation.
diabetes, glaucoma, asthma, thyroid disease, difficulty in urination due to prostate gland enlargement, alcoholism, any other serious disease or condition or if you are pregnant, nursing or on any other medication.
- blood problems (low white or red blood cell count) or bladder problems (pain, frequent urination, infection).
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with MOTRIN* COLD & SINUS include: coumarin-type anticoagulants, acetylsalicylic acid, other anti-inflammatory agents (NSAIDs), diuretics, acetaminophen, diabetes medications (hypoglycemics), decongestant or stimulant products (sympathomimetic agents), MAO inhibitors, digoxin, methotrexate, phenytoin, blood pressure medication (antihypertensives), oral glucocorticoids and lithium salts. IMPORTANT: PLEASE READ
MOTRIN* COLD & SINUS (ibuprofen/pseudoephedrine hydrochloride) Product Monograph Page 47 of 47
PROPER USE OF THIS MEDICATION
DOSAGE: Adults and children over 12 years of age:
1 or 2 caplets every 4 to 6 hours as needed. Do not exceed 6 caplets in 24 hours, unless directed by a doctor. Reduce dose if you feel nervous or cannot sleep.
Take with food or milk if mild upset stomach occurs with use.
Talk to a doctor if fever persists more than 3 days or if symptoms do not improve or new ones occur within 5 days.
Do not use in children under 12 years of age.
Overdose:
In case of accidental overdose, even if there are no symptoms, call a doctor or Poison Control Centre at once.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately: nausea, vomiting, abdominal pain or diarrhea; heartburn; bloating; constipation; fluid retention; skin rash, itching or high fever; dizziness; any change in vision; ringing or buzzing in the ears; restlessness or nervousness; sleeplessness or drowsiness. Always tell any other doctor or pharmacist you talk to that you are using this product.
This is not a complete list of side effects. For any unexpected effects while taking MOTRIN* COLD & SINUS, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature, 15°C - 25°C (59°F to 77°F). Avoid excessive heat and humidity.
Do not keep medicine that is outdated (after the expiry date).
Keep out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at: http://www.motrin.ca or by contacting the sponsor, McNeil Consumer Healthcare, at: 1-888-6MOTRIN or 1-888-666-8746.