Advice from FDA: Should you give kids medicine for coughs and colds?


Colds are a common illness that affect both adults and children. Most colds do not cause serious problems. In fact, most children get better on their own, without the need for medicine. However, since many cold symptoms (cough, nasal congestion, headache) are similar to symptoms of coronavirus disease 2019 (COVID-19) and the flu (influenza), it is important to talk with your healthcare provider to determine what the best course of action is to take.

If it is determined that your child has a cold, medicines usually are not recommended. Giving your child an over-the-counter (OTC) cough and cold medicine can result in serious side effects. In fact, the US Food and Drug Administration (FDA) does not recommend OTC cough and cold medicines for children younger than 2 years of age. Furthermore, manufacturers voluntarily include the statement, “Do not use in children under 4 years of age,” on the labels of these cough and cold products.

In addition, you may see products in your pharmacy or online that are being sold as natural, homeopathic, or vitamin products to help treat your child’s cold. These products are NOT FDA approved and may contain substances or active drug ingredients that could cause significant harm to children.

Here’s what you can do: If your child or infant has a cold, do NOT give them OTC medicines unless directed by the child’s healthcare provider. Also, do NOT give a homeopathic cough and cold medicine to children younger than 4 years of age. Instead, try some of the following tips to help relieve a young child’s or infant’s cough and cold symptoms:

· Use a cool mist humidifier, which decreases nasal congestion and makes breathing easier; do NOT use a warm mist humidifier since it can cause the nasal passages to swell, making breathing more difficult

· Use saline nose drops or sprays, which keep the nasal passages moist and help avoid stuffiness

· Use nasal suctioning with a bulb syringe, which helps clear out nasal passages, especially in young children

· Use acetaminophen or ibuprofen, which can help reduce fever, aches, and pains; however, be sure to follow the product instructions on the Drug Facts label and talk to the child’s healthcare provider before using

· Contact your healthcare provider if your child is not getting better or develops the following symptoms:

• A fever of 100.4o Fahrenheit (F) or higher in an infant 2 months or younger

•  A fever of 102o F or higher in children of any age

•  Blue lips

•  Labored breathing (widening nostrils with each breath), wheezing, fast breathing, ribs showing with each breath, or shortness of breath

•  Severe headache

•  Not eating or drinking

•  Decreased urination (a sign of dehydration)

•  Excessive crankiness or sleepiness

•  Persistent ear pain

•  If the child seems worse

· Go to the FDA website, Frequently Asked Question on Children’s Cough and Cold Medicines (, for more information

Advice from FDA is a feature brought to you by the FDA. You can find this information and more on FDA’s Consumer Health Information website at: This website features the latest updates on medicines and products regulated by the FDA. Sign up for a free email subscription at:

Created on February 16, 2022

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