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Use Caution When Giving Cough and Cold Products to Kids

Safety Information for Parents and Caregivers

Mother administering medicine to an infant

Children under 2 years of age should not be given any kind of cough and cold product that contains a decongestant or antihistamine because serious and possibly life-threatening side effects could occur. Reported side effects of these products included convulsions, rapid heart rates and death. What about older children? When giving cough and cold medicine to children over 2 years of age, parents and caregivers should use caution.

A meeting about the safety and effectiveness of cough and cold drug product use in children by the U.S. Food and Drug Administration in 2007 revealed that there were many reports of harm, and even death, in children who used these products. During 2004-2005, an estimated 1,519 children less than 2 years of age were treated in U.S. emergency departments for adverse events, including overdoses, associated with cough and cold medications. Manufacturers voluntarily removed over-the-counter (OTC) infant cough and cold products intended for children under 2 years of age due to these safety concerns.

Treating Toddlers and Older Children

Cough and cold products for children older than 2 years of age were not affected by the voluntary removal and these products are still sold in pharmacies and other retail outlets. Manufactures also voluntarily re-labeled these cough and cold products to state: “do not use in children under 4 years of age.” 

Parents need to be aware that many OTC cough and cold products contain multiple ingredients which can lead to accidental overdosing. Reading the Drug Facts label can help parents learn about what drugs (active ingredients) are in a product.

When giving children 4 years of age and older a cough and cold product, remember, OTC cough and cold products can be harmful if:

  • more than the recommended amount is used
  • they are given too often
  • more than one product containing the same drug is being used.

Children should not be given medicines that are packaged and made for adults. 

Other Options for Treating Colds

Here are a few alternative treatments for infants to help with cough and cold symptoms:

  • A cool mist humidifier helps nasal passages shrink and allow easier breathing. Do not use warm mist humidifiers. 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 -- with or without saline nose drops -- works very well for infants less than a year old. Older children often resist the use of a bulb syringe  
  • Acetaminophen or ibuprofen can be used to reduce fever, aches and pains. Parents should carefully read and follow the product’s instructions for use on the Drug Facts label  
  • Drinking plenty of liquids will help children stay hydrated.

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