FDA Issues Recommendation for Children's Cough and Cold Products

The FDA will continue to monitor the ongoing use of these products and the effects on children. Until all issues are resolved, the FDA recommends that parents and caregivers observe the following:

Do not give children medications labeled only for adults. Talk to your healthcare professional if you have any questions about using cough or cold medicines in children.
Choose OTC cough and cold medicines with child-resistant safety caps, when available.
To understand what symptoms the medicine are intended to treat, check the DRUG FACTS section of the label. Cough and cold medicines often have more than one active ingredient.
If you give more than one medicine to a child make sure that they do not have the same type of “active ingredients.” If you use two medicines that have the same or similar active ingredients, a child could get too much of an ingredient and that may hurt your child. Check with your doctor if you are uncertain.
Carefully follow the directions for how to use the medicine. If you have a question about how to use the medicine, ask your pharmacist or your doctor. Overuse or misuse of cold and cold products can lead to serious and potentially life threatening side effects.
Do not use common household spoons to measure medicines for children because household spoons come in different sizes are and not meant for measuring medicines. Only use the measuring device that comes with the medicine or one made specially for measuring drugs.
Using cough and cold medicines does not cure a cold or cough. These medicines are used only treat your child’s symptom(s) and do not shorten the length of time your child is sick.

After completing its review of information about the safety of over-the-counter (OTC) cough and cold medicines in 2008, the Food and Drug Administration (FDA) recommended that these drugs not be used to treat infants and children under two years of age because serious and potentially life-threatening side effects can occur.

As a result, the Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter cough and cold medicines in children, recently announced that it was modifying the product labels for OTC cough and cold medicines to state “do not use” in children under four years of age. The manufacturers also introduced new child-resistant packaging and new measuring devices for use with the products.

The FDA says it supports the voluntary actions of the CHPA to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA said it will continue to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. The agency said although the CHPA’s new labeling is inconsistent with its current monograph, it does not object to the new label modification, which reflects a more restrictive use of the drugs in children.

The agency said the steps taken by the CHPA won’t affect the availability of the medicines, but the voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others.

Some medicines will have the new recommendation “do not use” for children under four year of age, while others will instruct that they not be used for children under two years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, the FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication.

Do not, under any circumstances, give adult medications to children. If you are unsure or have questions about how to use a product, consult your child’s doctor or a pharmacist.