BLOOMINGTON - A Bloomington mother is suing two makers of over-the-counter cough and cold medicines, alleging the products were unsafe and resulted in the death of her infant son.

The 41-page lawsuit was expected to be filed late Tuesday on behalf of Dimitria D. Alvarez of Bloomington individually and as administrator of the estate of her son, Devon J. Mehlberg-Alvarez, who was 4 months old when he died on Oct. 8, 2001.

Dimitria Alvarez is suing McNeil-PPC Inc., the New Jersey-based maker of Infant Tylenol Cold Decongestant Plus Cough, and Walgreen Co., the Illinois-based retailer of Infant Tylenol drops and Walgreen's Pediatric Drops-Cough Plus Cold.

The U.S. Food and Drug Administration has conducted hearings on whether the medicines were safe for children. Other infant deaths have been associated with an ingredient in the medicines, and McNeil and Walgreen have voluntarily recalled the products.

Ralph Davis, the lawyer for Alvarez and her husband, Melecio Alvarez, decided to file the lawsuit, using overnight mail, in Lake County because that's where Walgreen is based. A clerk in the Lake County circuit clerk's office said Tuesday afternoon that the suit had not yet been filed but that lawsuits that arrived by mail would be filed by the end of the day.

"We have not seen the lawsuit yet, so we can't comment on the allegations," Walgreen corporate spokeswoman Carol Hively said. "Our labeling for these cough and cold products, including use restrictions, was in compliance with FDA regulations.

"We were among the first retailers to voluntarily recall these products last month out of an abundance of caution," Hively continued. "The FDA has not found that these products are unsafe when used as directed."

Efforts to get a comment from McNeil were not successful.

The lawsuit doesn't specify a dollar amount for damages, but Davis said the family would be seeking more than $50,000.

"This may be the first case against manufacturers of infant cold and cough medicines with dextromethorphan," a cough suppressant, Davis said.

On Oct. 4, 2001, Devon had a cold and a pediatrician recommended over-the-counter cold and cough medicine.

His mother gave Devon Infant Tylenol Drops and Walgreen's Pediatric Drops, the lawsuit said. Four days later, he died.

The cause of death was dextromethorphan intoxication. Tests showed that Devon's system processed the ingredient slowly, allowing a toxic level to build up in his system, the lawsuit said.

Last month, Alvarez learned of upcoming FDA hearings on the safety of cough and cold medicines for children, that dextromethorphan had no therapeutic value in infants, that other infant deaths had been associated with the ingredient, and that McNeil and Walgreen had voluntarily recalled their infant cold and cough products, the lawsuit said.

Until then, she thought that the fatal buildup of dextromethorphan was because of Devon's inability to metabolize the ingredient, not because the products were unsafe, Davis said.

The lawsuit argues that McNeil and Walgreen should have known of the hazards of dextromethorphan, that slow metabolism could lead to toxic buildup, that the two medicines had never been tested for use by infants, and that there had been deaths associated with the ingredient.