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Children’s Advil Cold & Sinus
ibuprofen - pseudoephedrine
How does this medication work? What will it do for me?
This product is a combination of 2 medications: ibuprofen and pseudoephedrine. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that reduces pain, fever, and inflammation by reducing a substance in the body that leads to inflammation and pain. Pseudoephedrine is a decongestant that relieves the symptoms of nasal and sinus congestion by reducing swelling in nasal passages and sinuses.
This medication is used to relieve nasal congestion, sinus congestion, sinus pain, fever, headache, sore throat, and body aches and pains that are associated with the common cold, sinusitis, or the flu.
Your doctor or pharmacist may have suggested this medication for conditions other than the ones listed in this drug information article. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor or pharmacist.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor or pharmacist has not recommended it.
What form(s) does this medication come in?
Each 5 mL of grape-flavoured, purple liquid contains 100 mg of ibuprofen and 15 mg of pseudoephedrine. Nonmedicinal ingredients: carboxymethylcellulose sodium, citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, artificial grape flavour, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.
Ibuprofen and Pseudoephedrine by McNeil Consumer Healthcare
How should I use this medication?
The usual recommended dose for adults and children older than 12 years is 1 or 2 caplets or liqui-gels every 4 to 6 hours as needed. Do not take more than 6 caplets or liqui-gels in 24 hours unless recommended by your doctor. Do not take for more than 3 days for a fever or for more than 5 days for cold symptoms.
For the children’s suspension, the dose depends on the child’s age and weight and is given every 6 hours as needed. Do not give more than 4 doses a day unless recommended by your doctor. Use an oral syringe or medication cup to measure each dose of the suspension, as it gives a more accurate measurement than household teaspoons. Shake the suspension well before measuring a dose.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the one listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as recommended by your doctor or pharmacist. If you are taking this medication regularly and you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic or sensitive to ibuprofen, pseudoephedrine, or any ingredients of the medication
- are allergic to other NSAIDs (e.g., naproxen, ketoprofen, diclofenac) or ASA (acetylsalicylic acid)
- are about to have or have just had heart surgery
- are dehydrated due to vomiting, diarrhea, or not drinking enough fluids
- are taking another NSAID (e.g., naproxen, diclofenac, ketoprofen)
- are pregnant or breast-feeding
- have a stomach ulcer, intestinal ulcer, ulcerative colitis, or Crohn’s disease
- have angioedema syndrome
- have experienced wheezing or difficulty breathing from ASA or other NSAIDs (e.g., naproxen, diclofenac, ketoprofen)
- have kidney disease, or reduced or worsening kidney function
- have nasal polyps
- have Raynaud’s Syndrome
- have serious liver disease or reduced liver function
- have severe heart disease
- have severe high blood pressure
- have high levels of potassium in the blood
- have systemic lupus erythematosus
- have taken a monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine) within the last 14 days
- have thyroid disease
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal pain
- bloating or gas
- difficulty sleeping
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- blurred vision or other eye symptoms
- fast, pounding heartbeat (palpitations)
- fluid retention
- ringing in the ears
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don ‘t stop bleeding)
- skin rash
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
- symptoms of a severe allergic reaction (difficulty breathing, hives, swelling of the mouth or throat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
June 8, 2021
Health Canada has issued new information concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs). To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.
A previous advisory on non-steroidal anti-inflammatory drugs (NSAIDs) was issued on October 30, 2020.
Allergy: Some people who are allergic to acetylsalicylic acid (ASA) or other anti-inflammatory medications also experience allergic reactions to ibuprofen. Before you take this medication, inform your doctor about any previous adverse reactions you have had to medications, especially anti-inflammatory medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.
Bleeding problems: If you have bleeding problems (e.g., hemophilia) or are taking anticoagulants (e.g., warfarin), you should not take this medication, unless recommended by your doctor.
Dependence and withdrawal: Physical dependence can occur with the use of pseudoephedrine for too long a period of time or at doses that are greater than the recommended amount. If this medication is stopped suddenly after using it for longer than recommended or at high doses, you may experience withdrawal symptoms such as anxiety, agitation, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.
Diabetes: Ibuprofen – pseudoephedrine may cause a loss of blood glucose control, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Drowsiness and dizziness: This medication can cause drowsiness and dizziness that may affect your ability to drive or operate machinery safely. If this medication affects you this way, do not perform these tasks.
Fluid retention: This medication can cause fluid retention. If you have heart failure or high blood pressure, fluid retention may worsen your condition. If you notice worsening of the symptoms of heart failure or your blood pressure increases while taking this medication, contact your doctor.
General: If your symptoms do not improve, contact your doctor. Do not use this medication for longer than 3 days for a fever or 5 days for pain or cold symptoms without consulting your doctor or pharmacist.
Glaucoma: This medication may cause the symptoms of glaucoma (increased pressure in the eye) to become worse. If you have glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report any changes in vision to your doctor as soon as possible while you are taking this medication.
Heart problems: The cardiovascular system (heart and blood vessels) may be affected by the use of this medication. Ibuprofen can cause fluid to build up in the body. This alone can cause increased blood pressure and symptoms of congestive heart failure to become worse.
Pseudoephedrine can cause blood vessels to narrow, increasing blood pressure. It may also cause increased heart rate or irregular heartbeat. If you have a history of heart attack, angina, stroke or other conditions that can be worsened by changes to the heart and blood vessels, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney problems: This medication may cause kidney problems. If you have reduced kidney function, heart failure, are taking diuretics (e.g., hydrochlorothiazide, furosemide), or are a senior, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Although rare, people taking ibuprofen-pseudoephedrine may have changes in liver function that produce abnormal liver test results. If you have a history of liver problems, discuss with your doctor or pharmacist how this medication may affect your medical condition and whether any special monitoring is needed.
Stomach ulcers and bleeding: Ibuprofen may cause ulcers or bleeding in the stomach or intestines. If you experience black, tarry stools, vomit that looks like coffee grounds, or stomach pain while taking this medication, contact your doctor immediately. If you have a history of stomach problems, discuss with your doctor or pharmacist how this medication may affect your medical condition and whether any special monitoring is needed.
Thyroid problems: If you have a thyroid condition, this medication may cause symptoms of overactive thyroid. If you are taking medications for an overactive thyroid or experience symptoms such as feeling hot all the time, weight loss without a change in your diet or amount of exercise you get, or feeling emotional, contact your doctor.
Urinary tract problems: This medication may cause bladder pain, painful or difficult urination, or increased frequency of urination. If you have an enlarged prostate gland, the difficulty urinating may be more pronounced. If these symptoms occur without an explanation (e.g., infection), stop taking this medication and contact your doctor.
Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication should not be used while breast-feeding.
Children: The caplets and liquid-gels should not be given to children less than 12 years old. The liquid form of the medication should not be given to children less than 6 years old.
Seniors: Seniors may be more likely to experience side effects from this medication.
What other drugs could interact with this medication?
There may be an interaction between ibuprofen – pseudoephedrine and any of the following:
- acetylsalicylic acid (ASA)
- alpha-agonists (e.g., clonidine, methyldopa)
- alpha-blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
- aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
- amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
- angiotensin-converting enzyme inhibitors (ACEIs; captopril, ramipril)
- angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
- anticoagulants (e.g., dalteparin, enoxaparin, heparin, warfarin, apixaban, dabigatran, rivaroxaban)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- "azole" antifungals (e.g., fluconazole, voriconazole)
- beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
- bisphosphonates (e.g., alendronate, etidronate)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
- decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
- diabetes medications (e.g., chlorpropamide, glyburide, insulin, metformin, rosiglitazone)
- diuretics (e.g., hydrochlorothiazide, furosemide, triamterene)
- ergot alkaloids (e.g., ergotamine, dihydroergotamine)
- fast-acting bronchodilators (e.g., salbutamol, terbutaline)
- herbs that may increase the risk of bleeding (e.g., cat’s claw, dong quai, feverfew, garlic, ginger)
- long-acting bronchodilators (e.g., formoterol, salmeterol)
- lumacaftor and ivacaftor
- MAO inhibitors (i.e., moclobemide, phenelzine, selegiline)
- omega-3 fatty acids
- other NSAIDs (e.g., naproxen, diclofenac, ketorolac)
- pentosan polysulfate sodium
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- serotonin-norepinephrine reuptake inhibitors (SNRIs; desvenlafaxine, duloxetine, venlafaxine)
- sodium phosphates
- theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
- thyroid replacements (e.g., dessicated thyroid, levothyroxine)
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, and street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2022. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Childrens-Advil-Cold-Sinus