Patient Medication Information: uses, side effects, how to take - Children's Motrin Cold
ABOUT THIS MEDICATION
What the medication is used for:
Relief of symptoms associated with sinusitis, the common cold or flu including:
- Stuffy Nose
- Sinus Pressure
- Sinus Pain
- Fever
- Body Aches & Pains
- Sore Throat Pain
- Headache
What it does:
Ibuprofen is a pain reliever and fever reducer and pseudoephedrine hydrochloride is a nasal decongestant.
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs block the production of prostaglandins that are involved in pain and fever development.
Pseudoephedrine hydrochloride acts on receptors in the respiratory mucosa. This helps to shrink swollen nasal membranes and to relieve congestion.
When it should not be used:
Do not use Children’s MOTRIN® Cold in patients who:
- are taking acetylsalicylic acid (ASA), other NSAIDs, other ibuprofen- or pseudoephedrine-containing products or any other pain or fever medicine.
are allergic to ibuprofen, pseudoephedrine hydrochloride, products containing ASA, other NSAIDs or
salicylates or any ingredient in the formulation (see What the nonmedicinal ingredients are).
- have ASA-sensitive asthma, active or recurrent stomach or intestinal ulcer, gastrointestinal (GI) bleeding or active inflammatory bowel disease (e.g. Crohn’s, colitis), liver or kidney disease and/or suffered significant fluid loss (i.e. diarrhea, dehydration), high blood pressure or heart disease, hyperkalemia (high potassium levels) or Systemic Lupus Erythematosus.
are pregnant, nursing or taking a prescription monoamine oxidase inhibitor (MAOI - drugs for depression, psychiatric or emotional conditions or Parkinson’s disease) or for two weeks after stopping an MAOI drug.
What the medicinal ingredients are:
Ibuprofen and Pseudoephedrine
Hydrochloride
What the nonmedicinal ingredients are: (To be supplied as appropriate for the formulation)
Berry: acesulfame potassium, citric acid, corn starch, D&C yellow #10, FD&C red #40, flavours, glycerin, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.
Dye Free Berry: acesulfame potassium, citric acid, corn starch, flavours, glycerin, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.
Grape: acesulfame potassium, citric acid, corn starch, D&C red #33, FD&C blue #1, FD&C red #40, flavours, glycerin, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum
What dosage forms it comes in:
Children’s MOTRIN® Cold is available in Berry, Grape and Dye-Free Berry in a 120 mL bottle.
WARNINGS AND PRECAUTIONS
BEFORE giving Children’s MOTRIN® Cold to your child, talk to your doctor or pharmacist if:
- your child is dehydrated (significant fluid loss) due to continued vomiting, diarrhea or lack of fluid intake.
- your child has peptic ulcers or a history of peptic ulcers, stomach bleeding or other bleeding problems, GI tract irritation or is prone to GI tract irritation, diabetes, glaucoma, high blood pressure, thyroid or heart disease, serious kidney or liver disease, asthma, blood problems (low white or red blood cell count), bladder problems (pain, frequent urination, infection) or is pregnant, nursing, under a doctor's care for any other serious condition or taking any other drug.
Also, see to your doctor if:
- your child does not get any relief within 24 hours.
- a sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting.
- if any new symptoms appear
Always tell any other doctor or pharmacist you consult, that your child is taking this medicine.
INTERACTIONS WITH THIS MEDICATION
Do not use this product if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric/emotional conditions, Parkinson’s disease), or for 2 weeks after stopping a MAOI drug. If you are uncertain that your prescription drug contains a MAOI, talk to your doctor before taking this product.
Talk to a doctor before using Children’s MOTRIN® Cold if your child is taking ASA or other NSAIDs, blood thinning medications (anticoagulants), blood pressure medication (anti-hypertensives), diuretics (water pills), lithium, diabetes medications (hypoglycemics), decongestant or stimulant products (sympathomimetic agents), methotrexate, phenytoin, digoxin, oral glucocorticoids or any other pain or fever medicine (such as acetaminophen).
PROPER USE OF THIS MEDICATION
Shake well before using. Use only enclosed measuring cup. Replace original bottle cap to maintain child resistance.
Use the chart below to find the correct dose. If possible, use weight to dose, otherwise use age.
| Weight | Age | Single Oral Dose | ||
| lbs. | kg | Years | mL | tsp |
| Under 36 | Under 16 | Under 4 | As directed by your doctor. | |
| 36-47 | 16-21.9 | 4-5 | 5 mL | 1 tsp |
| 48-95 | 22-43.9 | 6-11 | 10 mL | 2 tsp |
Doses may be repeated every 6 hours, up to 4 times a day.
Do not use Children’s MOTRIN® Cold for children under 4 years of age, unless instructed by your doctor.
If stomach upset occurs, take with food or milk. If the stomach upset does not go away, talk to your doctor.
Children’s MOTRIN® Cold should not be taken for more than 5 days. If symptoms do not improve, or are accompanied by fever that persists for more than 3 days, if new symptoms occur, or if your child feels nervous, dizzy or cannot sleep, stop use and consult your doctor.
Overdose:
Call a Poison Control Centre or doctor at once, even if there are no symptoms.
Missed Dose:
If you miss a dose, take the missed dose as soon as you remember. Do not take two doses at the same time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
If unusual symptoms or any of the following reactions develop during treatment stop using the product 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.
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. If they occur, stop using this product and get emergency medical help immediately.
This is not a complete list of side effects. For any unexpected effects while taking Children’s MOTRIN® Cold, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature, 15°C - 30°C (59°F to 86°F). . Do not keep medicine that is outdated (after the expiry date).
Keep this medication 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.website.document
or by contacting the sponsor, McNeil Consumer Healthcare, Division of Johnson & Johnson Inc. at:
1-888-6MOTRIN (1-888-666-8746)