- Withdrawal of oral cough/cold medicines for children under the age of
- Background on the reviews being conducted by Health Canada and the
United States Food and Drug Administration
- Advice to parents on the safe and effective use of cough/cold medicines
OTTAWA, Oct. 11 /CNW Telbec/ - Members of the Nonprescription Drug
Manufacturers Association of Canada today announced the voluntary withdrawal
of oral cough and cold medicines intended for use in children under the age of
two years. The withdrawal is a highly cautionary response to rare patterns of
misuse identified during the course of a review of safety data related to
children's cough and cold medicines. When used as directed, these products are
recognized as safe and effective; however this is a precautionary mesure to
avoid potential misuse of these products, including unintentional overdoses,
in children under the age of two.
The withdrawal does not affect cough and cold products intended for
children two years of age or older nor does it affect pain relievers and fever
reducers intended for use in children under the age of two years. These
products remain available to parents and caregivers.
The medicines being withdrawn include:
Infant Tylenol(R) Cold dye free drops
Benylin (R) for Infants Cough and Cold Oral Drops
Benylin (R) for Infants Stuffy Nose Oral Drops
Dimetapp (R) Oral Infant Cold Drops
Dimetapp (R) Oral Infant Cold and Fever Drops
Dimetapp (R) Oral Infant Cold Drops Dye Free
Every year, millions of Canadians rely on cough and cold medicines to
treat symptoms safely and effectively, both for themselves and for their
families. The safety and effectiveness of the ingredients in these medicines,
as well as their label directions and dosing instructions for children, are
reviewed and approved by Health Canada before market authorization is granted.
As research methodologies and techniques have advanced, there has been
recognition of the need to reassess the appropriate use of these medicines in
children. For this reason, Industry, Health Canada and the United States Food
and Drug Administration are currently reviewing the available evidence on
cough and cold medicine use in children, with a view to ensuring that such use
continues to be safe and effective. It was during the course of this review
that the industry identified the misuse issue that has prompted the withdrawal
of oral cough and cold medicines for use in children under the age of two
NDMAC and its member companies are committed to working with Health
Canada toward to ensure the safety and efficacy of cough and cold medicines
for children. We understand that Canadian parents may be concerned about how
they should proceed when their children suffer from the symptoms of coughs and
colds. We strongly urge all parents and caregivers to adhere to the following
measures when treating their children with cough and cold medicines:
- Do not give cough and cold medicines to children under the age of
- Always read and follow label directions carefully when giving any
medicine to your child.
- Never give a cough/cold medicine to your child unless it has
specific dosing instructions for their age group.
- Do not use cough and cold medicines with any other medicines unless
you consult your doctor or pharmacist first.
- Do not use antihistamines (allergy medicines) to calm children or
help them get to sleep.
- When using medicines that come in liquid form, be sure to use an
appropriate measuring spoon/device to administer the correct
dosage. These are readily available in all pharmacies.
- If you are ever unsure about the appropriate use of a medicine for
your child, consult a pharmacist, doctor or your provincial health
information service (e.g. BC HealthGuide or Nurseline, Saskatchewan
Healthline, Telehealth Ontario, Info Santé, etc.).
- Always keep all medicines out of the reach of children and know the
telephone number of your local poison control centre in the event
that accidental ingestion of a medicine by a child does occur.
NDMAC is a 111 year-old trade association representing the self-care
health products industry, including the manufacturers of cough and cold
For further information:
For further information: or to schedule an interview, Gerry Harrington,
Director of Public Affairs, NDMAC - Advancing Canadian self-care, (613)
723-0777, Cell: (613) 863-3716, Fax: (613) 723-0779, e-mail: