Update on the Health Canada temporary exception to import a limited amount of Children’s Advil®suspension (ibuprofen oral suspension)
The COVID-19 pandemic, an unprecedented cold and flu season, and a dramatic spike in RSV has created a significant strain on parents, families, and our healthcare system. The surge in these illnesses has created a dramatic increase in demand of pediatric analgesic products both in hospitals and at the retail level, making it very difficult to find product on shelves.
We are working around the clock to explore every possible option to help meet this unprecedented demand. We have increased our production output in Canada over 200% since August 2022 compared to 2021, and imported product for Canadian hospitals and retailers.
If you can’t find the ADVIL® product you’re looking for, we encourage you to connect with your healthcare professional for guidance on alternative formats or other pain relief options that may be appropriate for your family.
Importation of U.S. Product
Health Canada has permitted a temporary exception to import a limited amount of Children’s Advil ibuprofen suspension products from our U.S. supply network, for retail sale.
The imported U.S. labelled Children’s Advil ibuprofen suspension products will be temporarily available in two product varieties:
- Children’s Advil Suspension Bubble Gum for ages 2-11 years (100mg per 5mL)
- Infants’ Advil Concentrated Drops White Grape (Dye-Free) for ages 6-23 months (50mg per 1.25 mL)
The U.S. labelled Children’s Advil Suspension Bubble Gum product has the same concentration, dosage form and route of administration as the Canadian-authorized Children’s Advil Suspension Bubble Gum (Dye-Free) product (DIN 02232297). NOTE: This imported product does have some differences when compared to our Canadian product, including but not limited to:
- Difference in inactive ingredients – the imported product contains FD&C Red 40 dye compared to the Canadian formulation which is dye-free.
- Some differences in indications, both the U.S. and Canadian products are indicated for pain and fever relief.
- Differences in ages the product should be used in and directions for use. The U.S. product is labelled for use in ages 2-11 years; Canadian product is labelled for use in ages 2-12 years.
- Differences in storage conditions, the U.S. product label instructs to store the product between 20⁰ – 25⁰C while the Canadian product label instructs to store at room temperature between 15⁰ – 30⁰C.
- English-only labelling (Click here to access French labelling)
- Some differences in warnings and precautions – Click here to access Canadian Children’s Advil Suspension product labelling.
The imported Infants’ Advil Concentrated Drops White Grape (Dye-free) product has the same formulation, concentration, dosage form and route of administration as the Canadian-authorized Advil Pediatric Drops Grape (Dye-Free) (DIN 02242522). NOTE: This imported product does also have some differences when compared to our Canadian product, including but not limited to:
- Some differences in indications, both the U.S. and Canadian products are indicated for pain and fever relief.
- Differences in ages the product should be used in and directions for use. The U.S. product is labelled for use in ages 6 – 23 months; Canadian product is labelled for use in ages 4 months – 3 years.
- Differences in storage conditions, the U.S. product label instructs to store the product between 20⁰ – 25⁰C while the Canadian product label instructs to store at room temperature between 15⁰ – 30⁰C.
- English-only labelling(Click here to access French labelling)
- Some differences in warnings and precautions – Click here to access Canadian ADVIL pediatric drops product labelling
The U.S. labelled products should be used as directed.
Note to Healthcare Professionals: The imported Children’s Advil Suspension Bubble Gum product indicates to ‘ask a doctor’ for dosage guidance for children under 2 years, with the Infants’ Advil Concentrated Drops White Grape (Dye-Free) indicating to ‘ask a doctor’ for use in children under 6 months. We ask for your support to provide guidance accordingly to parents/caregivers if contacted.
Both imported products, are packaged in child-resistant containers. You can find additional information below on the imported products.
Remember to always store medications out of children’s reach.
Children's ADVIL®Bubblegum IBUPROFEN suspension 120mL
Uses
Temporarily:
- Reduces fever
- Relieves minor aches and pains due to the common cold, flu, headaches, toothaches, and sore throat
Dosage
Dosing Information:
Shake well before using
Repeat dose every 6-8 hours, if needed
Do not use more than 4 times a day
Find right dose on chart below. If possible, use weight to dose; otherwise use age.
Only use the measuring device that comes with the product to be sure you give the right dose.
| Dosing Chart | ||
|---|---|---|
| Weight (lb) | Age (yr) | Dose (mL) |
| Under 24 lb | Under 2 yr | Ask a doctor |
| 24-35 lb | 2-3 yr | 5 mL |
| 36-47 lb | 4-5 yr | 7,5 mL |
| 48-59 lb | 6-8 yr | 10 mL |
| 60-71 lb | 9-10 yr | 12,5 mL |
| 72-95 lb | 11 yr | 15 mL |
Ingredients
Active Ingredient: (in each 5mL) Solubilized ibuprofen equal to Ibuprofen 100 mg (NSAID)* *Nonsteroidal anti-inflammatory drug Inactive Ingredients: carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, natural and artificial flavor, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Use as directed. Read complete warnings and information.
Potential Health effects
Shake well before using and do not use more than 4 times a day. This product contains ibuprofen, which may cause allergic reaction, especially in those allergic to aspirin. This product contains an NSAID, which may cause severe stomach bleeding.
See product label for full product information and warnings.
Infants’ ADVIL® Concentrated Drops White Grape (Dye-Free) IBUPROFEN suspension 15mL
Uses
Temporarily:
- reduces fever
- relieves minor aches and pains due to the common cold, flu, headaches and toothaches
Dosage
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- shake well before using
- find right dose on chart. If possible, use weight to dose; otherwise use age
- repeat dose every 6-8 hours, if needed
- do not use more than 4 times a day
- measure with the dosing device provided. Do not use with any other device.
| Dosing Chart | ||
|---|---|---|
| Weight (lb) | Age (yr) | Dose (mL) |
| under 6 mos | ask a doctor | |
| 12-17 lb | 6-11 mos | 1.25mL |
| 18-23 lb | 12-23 mos | 1.875 mL |
Ingredients
Active Ingredient:
(in each 1.25 mL)
Ibuprofen 50 mg(NSAID)*
*Nonsteroidal anti-inflammatory drug
Inactive Ingredients: acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Use as directed. Read complete warnings and information.
Potential Health effects
Shake well before using and do not use more than 4 times a day. This product contains ibuprofen, which may cause allergic reaction, especially in those allergic to aspirin. This product contains an NSAID, which may cause severe stomach bleeding.
See product label for full product information and warnings.
Rinse the oral syringe with tap water only.