The critics, who include public health officials and pediatricians, are urging the government for stricter warnings to make parents aware of life-threatening overdoses.
AP quotes Dr. Charles Ganley, director of the FDA's office of nonprescription drug products as saying, "We have been looking at this issue internally with regard to the safety and efficacy of the use of these products in children."
Apart from Thursday's petition, many health agencies including the American Academy of Pediatrics have been issuing health warnings to parents since 1997. According to a recent data from the Centers for Disease Control and Prevention, more than 1,500 children have been hospitalized over a two-year period because of the drug overdose.
Advising the parents to consult a doctor before giving the remedies to children under age 2, Linda A. Suydam, president of the Consumer Healthcare Products Association, which represents makers of over-the-counter, or OTC, medicines said, "OTC cough and cold remedies have a long history of safety when used according to the label."
"The most important information for all consumers is that OTC medicines are real medicines and must be used according to the label instructions at all times," Suydam said in a statement.
Additionally, the petition has also asked the FDA to make it mandatory for labels to write that the products are not meant to treat children younger than 6. The FDA has planned a teleconference later Friday to its planned review.


