Ibuprofen Oral Suspension USP: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Caution in those with heart failure, high blood pressure or other conditions that may cause excess fluid collecting in tissues.
• Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer. The chance of stomach bleeding is higher if you: have had stomach ulcers or bleeding problems, take a blood thinner or steroid drug, take with other drugs containing an NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or prescription anti-inflammatory drugs.
• Caution in patients at risk of kidney problems, including the elderly or those using diuretics.
• Stop use immediately if you have difficulty or pain when urinating.

What is IBUPROFEN ORAL SUSPENSION USP used for?

Up to 8 hour relief of fever

The effective, temporary relief of: Fever and temporary relief of minor aches and pains due to:

• Sore throat
• Earache
• Colds & Flu
• Headache
• Toothache
• Immunization
• Body aches, sprains and strains

How does IBUPROFEN ORAL SUSPENSION USP work?

Ibuprofen is a member of a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work within the body by blocking the production of substances called prostaglandins, which are involved in the development of pain and inflammation.

What are the ingredients in IBUPROFEN ORAL SUSPENSION USP?

Medicinal ingredients: Ibuprofen

Non-medicinal ingredients:

Bubble Gum Flavour: A red-coloured oral suspension with a bubble gum aroma. Non-Medicinal Ingredients include; Carboxymethylcellulose sodium, citric acid, edetate disodium dihydrate, FD&C Red No. 40, flavour, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution and sucrose.

Dye-Free Berry Flavour: A white oral suspension with a berry aroma. Non-Medicinal Ingredients include; Carboxymethylcellulose sodium, citric acid, edetate disodium dihydrate, flavour, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution and sucrose.

Fruit Punch Flavour: A red-coloured, oral suspension with a fruit punch aroma. Non-Medicinal Ingredients include; Carboxymethylcellulose sodium, citric acid, edetate disodium dihydrate, FD&C Red No. 40, flavour, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution and sucrose.

Grape Flavour: A purple-coloured, oral suspension with a grape aroma. Non-Medicinal Ingredients include; Carboxymethylcellulose sodium, citric acid, edetate disodium dihydrate, FD&C Blue No.1 and FD&C Red No. 40, flavour, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution and sucrose.

Raspberry Blue Flavour: A blue-coloured oral suspension with a raspberry aroma. Non-Medicinal Ingredients include; Carboxymethylcellulose sodium, citric acid, edetate disodium dihydrate, FD&C Blue No. 1, flavour, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution and sucrose.

Tropical Punch Flavour: A red-coloured oral suspension with a tropical punch aroma. Non-Medicinal Ingredients include; Carboxymethylcellulose sodium, citric acid, edetate disodium dihydrate, FD&C Red No. 40, flavour., glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution and sucrose.

IBUPROFEN ORAL SUSPENSION USP comes in the following dosage forms:

Oral suspension, 100 mg/ 5 mL

Do not use IBUPROFEN ORAL SUSPENSION USP if:

• Your child is:

  • taking acetylsalicylic acid (ASA), any other nonsteroidal anti-inflammatory medication including any other ibuprofen product
  • allergic/hypersensitive to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), ASA or other salicylates, or to any of the inactive ingredients in this product (symptoms include facial or throat swelling, shortness of breath, low blood pressure)
  • dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.

• Your child has:

  • active or recurring stomach ulcer or gastrointestinal bleeding (bleeding in the urine or stool, or black stools)
  • Active inflammatory bowel disease (e.g. Crohn’s, colitis)
  • serious liver or kidney disease
  • Systemic Lupus Erythematosus
  • high potassium in the blood
  • nasal polyps (growth inside their nose)
• Your child had or is about to have heart surgery

To help avoid side effects and ensure proper use, talk to your healthcare professional before you give IBUPROFEN ORAL SUSPENSION USP to your child. Talk about any health conditions or problems your child may have, including if your child:

• has

  • previous or current peptic ulcers
  • high blood pressure
  • heart disease or had heart failure
  • kidney or liver disease
  • asthma
  • history of gastrointestinal disease, blood clotting problems, or taking an anticoagulant
  • diabetes

• is

  • suffering from stomach pain
  • under a doctor's care for any other serious condition or is taking any other drug

Other warnings you should know about:

• Long-term continuous use may increase the risk of heart attack or stroke

• See your doctor if:

  • your child does not get any relief within 24 hours
  • redness or swelling is present in the painful area
  • your child develops any vision problems (blurred or reduced vision, colour changes occur)

Stop use and ask a doctor if

• your child has signs of stomach bleeding
• pain worsens or lasts more than 5 days
• fever worsens or lasts more than 3 days
• your child’s sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting
• any new or unusual symptoms appear

Tell your healthcare professional about all the medicines your child takes, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with IBUPROFEN ORAL SUSPENSION USP:

• coumarin-type anticoagulants
• digoxin
• diuretics (water tablets)
• lithium salt
• methotrexate
• phenytoin

How to take IBUPROFEN ORAL SUSPENSION USP:

Shake suspension well before use. Use only the enclosed measuring cup or a measured teaspoon to dose this product. Do not use any other dosing device. Measure dose with the dosage cup provided and ensure the complete dose is taken. While uncommon, if stomach upset occurs, IBUPROFEN ORAL SUSPENSION USP can be given with food or milk. If stomach upset persists, talk to your doctor.

This product does not contain directions or complete warnings for adults use. It is intended for use in children.

Usual dose:

For accurate dosing, follow the instructions carefully. Find the right dose on the chart. If possible, use weight to dose, otherwise use age.

Single dose may be repeated every 6 to 8 hours as needed. Do not exceed 4 doses of ibuprofen per day unless advised by a doctor.

Use the lowest effective dose for the shortest duration.

Overdose:

If you think you, or a person you are caring for, have taken too much IBUPROFEN ORAL SUSPENSION USP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

What are possible side effects from using IBUPROFEN ORAL SUSPENSION USP?

These are not all the possible side effects your child may have when taking IBUPROFEN ORAL SUSPENSION USP. If your child experiences any side effects not listed here, tell your healthcare professional.

If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately:

• skin rash or itching, dizziness, any change in vision, ringing or buzzing in the ears, nausea, vomiting, sudden abdominal pain or long-term abdominal pain with the loss of appetite and/or jaundice and/or new onset of itching, diarrhea or constipation, heartburn, bloating, fluid retention, indigestion, headache, decreased appetite

Serious side effects and what to do about them

If your child has a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your child’s daily activities, tell your healthcare professional.

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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature between 15°C to 30°C.

Keep this and all medication out of the reach of children.

Child Resistant Package

If you want more information about IBUPROFEN ORAL SUSPENSION USP:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (Drug Product Database: Access the database); the manufacturer’s website (http://www.apotex.ca/products); or by calling 1-800-667-4708.

Last Revised: SEP 12, 2025