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Frequently Asked Question on Children’s Cough and Cold Medicines

Questions about Colds in Children

Q: Is there a cure for a cold?

There’s no cure for the common cold, a viral infection that can’t be treated with antibiotics. Typically, a cold will run its course in a week or two, and children will usually get better on their own, without medication. Some over-the-counter medicines can help relieve the symptoms of a cold—but won’t change the natural course of the cold or make it go away faster.

Coughs are a normal symptom of a cold and help the body clear the mucus out of the airway and protect the lungs. Non-drug treatments for coughs include drinking plenty of fluids, especially warm drinks to soothe the throat.

Q: Does a fever associated with a cold need to be treated?

Fever helps the body fight off an infection and does not always need to be treated. Acetaminophen or ibuprofen can be used to reduce fever, aches, and pains. Parents and caregivers should carefully read and follow the product’s instructions for use on the Drug Facts label or talk to your child’s doctor about dosing information before giving to children. Call a doctor if a child has a fever of 102 degrees Fahrenheit or higher.

Q: How common are colds?

A: In the United States, adults average about three colds per year, and children have colds even more often. You might be tempted to give your children pain relievers, decongestants, and other medications for a cold. But often it’s best to fight this common childhood illness with rest and care, using medications only when the symptoms are too uncomfortable or make it difficult to breathe or sleep.

The best way to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water, advises the Centers for Disease Control and Prevention (CDC). Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose.

Questions about over-the-counter (OTC) Cough and Cold Medicines for Children

Q: Why should children under two not use OTC cough and cold medicines?

Children under two 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.  Manufacturers voluntarily label these cough and cold products to state: “do not use in children under 4 years of age.”

CDER OTC cold remedy childrens

A meeting about the safety and effectiveness of cough and cold drug product use in children by the FDA 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 two years of age were treated in U.S. emergency departments for adverse events, including overdoses, associated with cough and cold medications. 

Q: Why does FDA allow OTC cough and cold medicines to be sold if they do not change the natural course of a cold or make it go away faster?

In older children and adults, OTC cough and cold medications can help reduce the discomfort caused by the common cold by treating symptoms such as runny nose, nasal congestion, and cough. However, a cold will run its course in a week or two and children (and adults) will usually get better on their own. OTC cough and cold medications are best used when the symptoms are too uncomfortable or make it difficult to breathe or sleep. Parents and caregivers should carefully read and follow the product’s instructions for use on the Drug Facts label or talk to your doctor or pharmacist about dosing information.  

Questions about Homeopathic Cough and Cold Products for Children

Q: How do I know if a cough and cold product is homeopathic? Are they labeled as “homeopathic?”

CDER Homeopathic cough and cold remedy


Homeopathic products are generally labeled as homeopathic and generally list ingredients in terms of dilution, e.g., 1X, 6X, 2C. The ingredients are listed using homeopathic names, which are often not terms that are familiar to consumers.  Examples of these ingredients include: “Nux vomica,” which contains strychnine and “plumbum aceticum” which is lead.

Homeopathic products are often placed on store shelves next to over-the-counter drugs that have undergone FDA review or that comply with an over-the-counter drug monograph, and packaging may not clearly identify that a particular product is labeled as homeopathic. The FDA is not aware of any proven benefits of homeopathic products.

Q: How are homeopathic products different than dietary supplements?

A dietary supplement is composed of dietary ingredients like vitamins, minerals, herbs, botanicals, and other food like ingredients. In general, dietary supplements are intended to be used to augment the diet to promote health. Dietary supplements cannot legally be sold to treat or prevent disease or disease symptoms.

In contrast, homeopathic products are classified as drugs. Homeopathic products are based in an alternative medical practice that was developed in the late 1700s. Homeopathic products may contain a wide range of substances, including ingredients derived from plants, minerals, chemicals, bacteria, and healthy or diseased animal or human sources. Often, the substances in these products have been so diluted that no remaining substance can be found in the product. However, some of these products have been found to contain measurable amounts of the ingredients they list as active drug ingredients and therefore could cause significant harm. Many homeopathic products include disease and disease symptom treatment claims, but these drugs have not been reviewed by FDA and no homeopathic product has ever been approved by FDA.

Q: Why has FDA not approved homeopathic cough and cold products?

Currently, no homeopathic product meets FDA’s standard for safety and efficacy. FDA has not approved any homeopathic products or found any to be generally recognized as safe and effective (GRASE).  

The continued marketing of products that have neither been approved by FDA nor found to be GRASE is a public health concern. Taking unapproved homeopathic products may also harm consumers who choose to forgo treatment for serious diseases and/or conditions with a medical product that has been scientifically proven to be safe and effective.

FDA issued a draft guidance: Drug Products Labeled as Homeopathic, which proposes a comprehensive, risk-based enforcement approach to homeopathic products marketed without FDA approval. FDA’s proposed approach prioritizes regulatory and enforcement actions involving unapproved homeopathic products that pose the greatest risk to patients.

FDA’s top concern is patient safety. When the draft guidance is finalized, it will specify the categories of products the agency intends to prioritize for enforcement. In the interim, before the draft guidance is finalized, FDA intends to apply its general approach to prioritizing risk-based regulatory and enforcement action.

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