Update on the Health Canada temporary exception to import a limited amount of Children’s TYLENOL® acetaminophen suspension
We know you may be having trouble finding our pediatric TYLENOL® products and we know it can be frustrating.
We have maximized our production in Canada to help Canadians get access to the consumer health products they need. In addition to increased production, we have been working closely with Health Canada to increase the availability of our Children’s TYLENOL® acetaminophen suspension products in Canada and have recently reallocated a limited quantity of our global supply to ensure Canadians can access the products they need.
Health Canada has permitted a temporary exception to import a limited amount of Children’s TYLENOL® acetaminophen suspension products from our global supply network, for retail sale.
The imported Children’s TYLENOL® acetaminophen suspension products will be temporarily available in two flavours, grape and dye free cherry. These products are the same concentration, and the weight- and age-based doses are the same as the Children’s TYLENOL® (DIN 02046040) acetaminophen suspension products that Canadians know and trust. In addition, the imported product, like the Canadian product, is packaged in a child-resistant container. NOTE: These imported products do have some differences when compared to our Canadian Children’s TYLENOL® acetaminophen suspension, including but not limited to:
- Differences in inactive ingredients
- English-only labelling (Click here to access French labelling)
- Larger product size (120mL) compared to Canadian product (100mL), and
- Some differences in warnings and precautions – Click here to access Canadian Children’s TYLENOL® acetaminophen suspension products labelling.
You can find additional information below on the imported products. For a printer-friendly version of French-labelling click here.
Note to Healthcare Professionals: The imported Children’s TYLENOL® acetaminophen suspension products indicate to ‘ask a doctor’ for dosage guidance for children under 2 years. We ask for your support to provide guidance accordingly to parents/caregivers if contacted.
Remember to always store medications out of children’s reach – get storage considerations here.
Pediatricians recommend TYLENOL® for pain and fever
Relied on by moms for over 60 years
Ages 2-11 years
Temporarily:
- Reduces fever
- Relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
- Alcohol Free
- Ibuprofen Free
- Aspirin Free
- No Parabens
Directions
This product does not contain directions or complete warnings for adult use.
Do not give more than directed (see overdose warning)
Shake well before using
mL = milliliter
Find right dose on chart below.
If possible, use weight to dose; otherwise, use age.
Remove the child protective cap and squeeze your child’s dose into the dosing cup
Repeat dose every 4 hours while symptoms last
Do not give more than 5 times in 24 hours
| Weight | Age | Single Oral Dose | |
|---|---|---|---|
| lbs | kg | years | mL |
| Under 24 | Under 11 | Under 2 | Ask a Doctor |
| 24-35 | 11-15.9 | 2-3 | 5 |
| 36-47 | 16-21.9 | 4-5 | 7.5 |
| 48-59 | 22-26.9 | 6-8 | 10 |
| 60-71 | 27-31.9 | 9-10 | 12.5 |
| 72-95 | 32-43.9 | 11 | 15 |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
| Active ingredient (in each 5 mL) | Purpose |
|---|---|
| Acetaminophen 160 mg | Pain reliever/fever reducer |
Inactive ingredients:
anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if your child has liver disease
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
When using this product do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other information
- each 5 mL contains: sodium 2 mg
- store between 20-25°C (68-77°F)
- do not use if carton tape or bottle wrap imprinted with “TYLENOL” is broken or missing