Know the Risks of Cold and Cough Options

Pharmacy TimesMarch 2019 Respiratory
Volume 85
Issue 3

Although multiple OTC products are available, they may not always be the best treatment for some pediatric patients

Pharmacists are likely to encounter requests for guidance from caregivers and parents regarding the use of the various OTC cold and cough products marketed for children.

More than 40% of caregivers or parents in a poll said they had given their children younger than 4 years at least 1 OTC cold and cough medicine, and 25% said they had given them decongestants.1

Many OTC cold and cough products are marketed to alleviate nasal symptoms, such as congestion, rhinorrhea, and sneezing, as well as coughs. However, evidence regarding the effectiveness of these treatments is inadequate and of low quality, and clear guidance is deficient.2 Study results show that longterm use of nasal decongestants can lead to chronic nasal congestion.3 The FDA does not recommend OTC medications for cold and cough symptoms in children younger than 2 years.4 Unfortunately, clinical trials and data are lacking for those younger than 12 years, who typically have the greatest incidence of colds.5

A review published in October 2018 in the British Medical Journal explored the effectiveness of treatments for the common cold in adults and children.5 The review results indicated that decongestants and medications containing antihistamines should not be given to children younger than 6 years and should be used with caution in those younger than 12 years.5 The results also showed that there is no evidence that these products effectively alleviate nasal symptoms in children, and there is cause for concern about adverse effects such as drowsiness and gastrointestinal upset. Additionally, the authors cited other possible serious adverse effects, such as convulsions, death, and tachycardia, in very young children.5,6 They also concluded that because antihistamines and decongestants do not shorten the duration or significantly improve the symptoms of common colds in children, clinicians should reassure caregivers and parents that colds are often self-limiting and typically resolve on their own within 7 to 10 days.5,6 These results give added weight to a 2008 FDA warning stating that no cold and cough products should be given to children younger than 2 years and should be used with caution in older kids.4,5 The American Academy of Pediatrics (AAP) also recommends against the use of OTC cold and cough remedies for children younger than 4 years.5

Caregivers and parents should contact their pediatricians for any concerns, especially those related to the following, according to the FDA4:

  • A cough that lasts more than 3 weeks
  • A fever in an infant 2 months or younger
  • A fever of 102°F or higher at any age
  • Diarrhea, nausea, or vomiting
  • Excessive irritability or sleepiness
  • Labored or rapid breathing or wheezing
  • Not drinking or eating, with signs of dehydration such as decreased urination
  • Persistent ear pain
  • Worsening symptoms

Parents and caregivers should also be cautious because children’s cold and cough products may have more than 1 ingredient, increasing the chance of accidental overdose if the remedy is combined with another product, according to the AAP.7

The AAP also recommends treating cold symptoms with home remedies such as7:

  • Applying a layer of a mentholated rub on the skin over the chest and neck (for children 2 years and older)
  • Keeping the patient hydrated
  • Suctioning with a nasal syringe bulb or using saline nose spray
  • Treating a fever according to recommendations from a pediatrician with antipyretics formulated for pediatric patients using the manufacturer provided calibrated measuring devices supplied with liquid products
  • Using a humidifier or a vaporizer as needed

As frontline health care providers, pharmacists can ease the concerns and fears of caregivers and parents and advise them to seek guidance from their pediatricians when they are in doubt. This is especially important for pediatric patients with preexisting medical conditions or those taking other medications.

Pharmacists can also encourage caregivers and parents to be vigilant about adhering to dosage, duration of use, and recommended manufacturer directions. Pharmacists can also provide the most recent clinical information about the proper and safe use of pediatric OTC cold and cough medications and direct them to educational resources from health organizations such as the AAP and the FDA.

Bio: Yvette C. Terrie, BSPharm, RPh, is a consulting pharmacist and a medical writer in Haymarket, Virginia.


1. 40% of parents give young kids cough/cold medicine that they shouldn’t [news release]. Ann Arbor, MI: C.S. Mott Children’s Hospital; April 19, 2013. Accessed January 4, 2019.

2. Allan GM, Arroll B. Prevention and treatment of the common cold: making sense of the evidence. CMAJ. 2014;186(3):190-199. doi: 10.1503/cmaj.121442.

3. Mehuys E, Gevaert P, Brusselle G, et al. Self-medication in persistent rhinitis: overuse of decongestants in half of the patients. J Allergy Clin Immunol Pract. 2014;2(3):313-319. doi: 10.1016/j.jaip.2014.01.009.

4. US Department of Health & Human Services. When to give kids medicine for coughs and colds. FDA website. Updated November 27, 2018. Accessed January 21, 2019.

5. van Driel ML, Scheire S, Deckx L, Gevaert P, De Sutter A. What treatments are effective for common cold in adults and children? BMJ. 2018;363:k3786. doi: 10.1136/bmj.k3786.

6. Nelson R. Do not use decongestants for colds in children younger than age 6. Medscape website. Published October 12, 2018. Accessed January 4, 2019.

7. American Academy of Pediatrics. Coughs and colds: medicine or home remedies? website. Updated November 21, 2018. Accessed January 4, 2019.

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