TUESDAY, Oct. 7 (Health.com) — The manufacturers of over-the-counter cough and cold medicines said Tuesday that such products should not be used in children under 4.
The leading makers of the products decided to voluntarily change the label after consulting with the Food and Drug Administration (FDA), according to the Consumer Healthcare Products Association, an industry trade group.
While pediatric versions of cough and cold remedies will still be available in supermarkets and pharmacies, they will have a new label that warns against use in children under 4. The labels will still recommend an appropriate dose for older children.
“In addition, for products containing certain antihistamines, manufacturers are voluntarily adding new language that warns parents not to use antihistamine products to sedate or make a child sleepy,” Linda Suydam, president of the Consumer Healthcare Products Association, said in a statement.
Expect to see such label changes during the 2008–2009 cough and cold season, the group said.
The use of cough and cold medications in very young children has come under scrutiny in recent years.
In January 2008, the FDA said such products should not be given to children under 2 years of age. Some children, mostly under 2, have died due to the misuse of the remedies. The Centers for Disease Control and Prevention estimates that 7,000 children under 11 are treated in emergency rooms each year due to problems with cough or cold remedies.
Parents could accidentally administer an overdose to children by using multiple products that contain similar ingredients, or by giving children the incorrect dose.
The FDA met last week to discuss the issue, and is considering a ban on such products for children ages 2–6.
Manufacturers are trying to do a better job of educating parents and caregivers. In addition to other recommendations, they say that caregivers should:
• Follow dosing recommendations exactly and use the measuring device sold with the product
• Avoid combining medicines that contain the same ingredients
• Never use such products to make a child sleepy
By Theresa Tamkins