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Infant cough and cold medicines have been pulled off store shelves because of growing concerns that they can harm or even kill young children.

Manufacturers in Canada and the United States Thursday announced a voluntary withdrawal because of “rare instances of misuse” that could lead to accidental overdose. Large pharmacy chains such as Shoppers Drug Mart said they would immediately stop selling the products.

There are more than 700 prescription and non-prescription cough and cold medicines sold in Canada, but only a handful – those intended for infants – are being withdrawn. They include: Tylenol Cold Dye Free Drops, Benylin for Infants Cough and Cold Drops, Benylin for Infants Stuffy Nose Infant Drops, Dimetapp Oral Infant Cold Drops, Dimetapp Oral Infant Cold and Fever Drops, Dimetapp Oral Infant Cold Drops Dye Free and Life brand Oral Infant Cold Drops.

“If you have these drugs at home, get rid of them,” said Michael Rieder, the head of clinical pharmacology at the Children's Hospital of Western Ontario in London and spokesman for the Canadian Paediatric Society.

He said the medicines should be returned to pharmacies for disposal, not dumped down the sink or thrown in the garbage.

Dr. Rieder said the best way to treat an infant with a cold or cough is with rest and plenty of fluids, and perhaps a single-ingredient painkiller for fever.

He said cough and cold medication does not work for infants and “parents need to ask themselves: Are they using these drugs to make their children feel better or to make themselves feel better?”

The voluntary withdrawal comes after years of mounting evidence about the dangers of these drugs and an impending crackdown.

Next week, the U.S. Food and Drug Administration will issue new rules for cough and cold medicines aimed at infants, including labelling that includes the words “do not use in children under two.” Independent safety experts are calling for even more sweeping restrictions, including explicit instructions that cough syrup should not be given to any child under six.

Cough and cold medications contain combinations of such drugs as dextromethorphan (a cough suppressant), diphenhydramine (an antihistamine designed to reduce swelling in the respiratory tract) and pseudoephedrine (a nasal decongestant). Taken to excess, these drugs can cause breathing problems and even death.

The medications sold over the counter feature different levels of these various drugs, which can leave parents confused about the proper dose and lead to accidental overdoses.

Cough and cold medicines are often taken in conjunction with a painkiller like acetaminophen (Tylenol) and ibuprofen (Motrin), which can exacerbate problems.

In a sweeping, 356-page safety review issued last month, the FDA said that between 1969 and 2006, at least 54 children died after taking decongestants, and 69 died after taking antihistamines. The report added that, since adverse drug reactions are reported voluntarily and fitfully, the numbers likely understate the medicines' true toll significantly.

Health Canada said Thursday that “life-threatening adverse events, including unintentional overdose, have been reported” in Canada, but it could not provide any numbers.

Health Canada said it is reviewing the rules related to the labelling of infant cold and cough medications and, in the meantime, it “strongly advises parents and caregivers to carefully read the labels and instructions for these products and to check the medicinal ingredients before giving them to any child, especially under the age of 2.”

The FDA report said that, in addition to their danger, there is little evidence that cough and cold medicines actually relieve symptoms, particularly in young children.

Last year, the Canadian Thoracic Society and the American College of Chest Physicians issued guidelines saying that cough and cold medications are of little use for adults either. The guidelines stressed that a cough is actually a protection mechanism that stimulates the upper airways and helps people recover from colds.

Bill Murphy, general manager of the over-the-counter business unit of McNeil Consumer Healthcare, said the company moved quickly to take its products off the market because of its “long-standing commitment to the appropriate use of medications by parents and physicians.”

He noted that only medications targeting children under 2 are being withdrawn, and that the drugs are “recognized as safe and effective” for older children when administered in the proper doses.

Single-ingredient pain relievers such as Tylenol Infant Drops and Motrin Oral Drops are not being withdrawn and they are not subject to the FDA safety warning.