The voluntary withdrawal of OTC oral infant cough and cold medicines was initiated by the makers of those medications out of an abundance of caution. This is not a mandatory recall or a safety issue.

• Kids’ OTC cough and cold medicines are both safe and effective when used correctly. Rare cases of overdose from misuse, however, have occurred—particularly in infants less than two years of age.
• Infants under the age of two are the most vulnerable to the consequences of this misuse.
• The voluntary withdrawal only affects oral infant cough and cold medications. It does not affect any other children’s medicines.
• OTC pediatric cough and cold medicines affected by this voluntary withdrawal are listed in the right column of this page, or visit http://www.OTCsafety.org.

Parents can continue to trust and rely on over-the-counter cough and cold medicines for their children, as they have for generations, because these medicines are safe at recommended doses.

• As with any medicine, it is important for parents to read the labels carefully, use these medicines only as directed, and make sure to safely store them out of the reach of children.
• Labels currently direct parents and caregivers to "ask a doctor" before giving these medicines to children under two. In September 2007, the makers of these medicines recommended to the U.S. Food and Drug Administration that medicine labels have stronger language instructing that parents "do not use" for children under two to prevent incidents of misuse.

Harm from OTC cough and cold medicines is rare and, when it does occur, is almost always the result of misuse (significant overdose or accidental swallowing due to medicine not being properly stored and secured).

• As with all medicines, dosing instructions for all over-the-counter remedies must be read and followed carefully. It is important to remember that any medicine can cause harm if taken or used improperly.
• Safe use and safekeeping are extremely important. Giving medicine according to label directions is part of the solution; storing it out of the sight and reach of children is part of it, as well.

Because children under age two are the most vulnerable to the harm caused by the misuse of oral, over-the-counter cough and cold medicines, the makers of these medicines have recommended strengthening their labels to state "Do Not Use" for children under two.

• This recommendation, as well as others, will be discussed before a U.S. Food and Drug Administration advisory committee on October 18 and 19. FDA asked for the meeting of outside experts to bring the best science to bear on this important issue.
• FDA requested analyses and recommendations from its staff of reviewers, but the agency has not and will not take an official position until after it has the opportunity to discuss and examine all the information.
• FDA has not called for a "ban" on or "recall" of these medicines.

The makers of over-the-counter cough and cold medicines want to ensure that parents and caregivers understand when and how to use these medicines safely.

The safe use of these medicines is our highest priority. We will soon launch a major national educational program to build awareness among parents and other caregivers about how to safely use over-the-counter medicines in children, and, as importantly, when not to use them.

Updated October 2007