FDA Reminder: Do Not Give Infants Cough and Cold Products Designed for Older Children

Decongestants and antihistamines can cause serious harm

/ Author:  / Reviewed by: Joseph V. Madia, MD

In January 2008, manufacturers voluntarily removed over-the-counter (OTC) infant (less than 2 years of age) cough and cold products from the market due to safety concerns.

Later in fall of 2008, manufacturers also voluntarily relabeled these cough and cold products to state: “do not use in children under 4 years of age.” However, there are concerns that many parents may be giving cough and cold products that remain on the market - those designed for older children - to their infants. FDA reminds all caregivers never to give a child under two years of age any kind of cough and cold product containing decongestants or antihistamines, without seeking the advice of a healthcare provider. These cough and cold products include those that contain the decongestants ephedrine, pseudoephedrine or phenylephrine, and the antihistamines diphenhydramine, brompheniramine or chlorpheniramine.

Research shows risks to children

Cough and cold products for children under two years old were voluntarily removed from the market because of on-going safety concerns discussed by the FDA in 2007. These safety concerns revealed that there were many reports of harm, and even death, to children who used these products. These reports of harm occurred when the child received too much medication such as in cases as accidental ingestion, unintentional overdose or after a medication dosing error. In those reports of harm that lead to a child’s death, most of those children were under two years of age.

FDA research indicates that children less than 2 years old appear to be the most susceptible to serious injury when there are no labeled directions for use but rather state “to ask a doctor (healthcare provider) for use.” It is not clear if these products are being given to infants under the advice of a healthcare provider or if the recommendation to speak to a healthcare provider leads caregivers to believe that infants are appropriate users of these drugs. For these reasons FDA supports manufactures actions to voluntarily withdraw cough and cold products for children under two years of age from the marketplace. However, cough and cold products for children older than two years of age were not affected and these products are still sold in pharmacies and other retail outlets today.

Since infant formulations of cough and cold products were voluntarily removed from the market years ago, parents who currently give these products to their infants (less than 2 years of age) may be using cough and cold products designed for older children and modifying the doses, for instance by giving half the recommended amount to the infant than what is recommended for an older child. This can be especially dangerous as dosing adjustments cannot safely be made this way and could add to the existing risk of giving these products to young children.

Alternatives to cough and cold medicines for infants

Parents of infants may not have heard the FDA warnings about cough and cold products in young children issued after the 2007 findings. Physicians are a valuable source of information for parents. Well-informed physicians can offer parents a variety of alternative treatments for infants to help with cough and cold symptoms. For instance, here are some commonly used recommendations:

  • A cool mist humidifier helps nasal passages shrink and allow easier breathing (do not use warm mist humidifiers as they can cause nasal passages to swell and make breathing more difficult);
  • Saline nose drops or spray keep nasal passages moist and helps avoid stuffiness;
  • Nasal suctioning with a bulb syringe either with or without saline nose drops, works especially well for infants less than a year old. Older children often resist its use;
  • Acetaminophen or ibuprofen can be used to reduce fever, aches and pains. Parents should carefully read and follow the product’s instructions for use label;
  • Drinking plenty of liquids will help the child stay well hydrated. 
Review Date: 
July 21, 2011