Cold and Cough Medicine for Infants and Children

The FDA recommends that children under the age of 2 should never be given over-the-counter (OTC) cough or cold medications.

There are varieties of cough and cold medicines available over the counter (OTC). The US Food and Drug Administration (FDA) recommends that children under the age of 2 should never be given over-the-counter (OTC) cough or cold medications. However, most cough and cold products state that cough and cold medicine should not be given to children under the age of 4.

Can I give my infant or child cold or cough medicine?

The short answer is probably not. The FDA says that over-the-counter cold medications should not be used in children younger than age 2.

The American Academy of Pediatrics does not recommend any over-the-counter cold medications for children younger than age 4.

The American College of Chest Physicians guidelines do not recommend cold and cough medications for children younger than age 15. For children younger than 15 years of age, they suggest that an anti-inflammatory medication like ibuprofen (Advil, Children's Advil/Motrin, etc.) or naproxen (Aleve) may be helpful with a cough. A decongestant may help with postnasal drip and cough suppression.

The following four categories of drugs are not recommended for children under the age of 4 (or 2, depending upon which guidelines you use):

1. Cough expectorants (guaifenesin)
2. Cough suppressants (dextromethorphan, DM)
3. Decongestants (pseudoephedrine and phenylephrine)
4. Certain antihistamines like brompheniramine, chlorpheniramine maleate, and diphenhydramine (Benadryl)

Aspirin should never be given to infants and children because of its association with Reye's syndrome, a condition that can cause swelling of the brain and liver. In the United States, the FDA recommends that aspirin should not be used in individuals 18 years of age and younger. In the United Kingdom, it is recommended that aspirin not be used in individuals 16 years of age and younger.

Acetaminophen (Tylenol) can be toxic to the liver if too much is taken at once or over a period of a few days. The correct dose is always listed on the bottle, and it is important not to exceed the recommended amount. When in doubt, ask your doctor, pharmacist, or other healthcare professional about the safety of acetaminophen in infants and children. Moreover, it is important to remember that the amount of medication required is based on the child's weight, not on their age.

Just because a cough or cold medication it is available over-the-counter, it does not mean that it is safe to use in all situations. Many cold medications depend on stimulants to shrink membranes and decrease nasal secretions. The body perceives phenylephrine and pseudoephedrine as adrenaline to the body. Antihistamines, like chlorpheniramine, brompheniramine, and diphenhydramine (Benadryl), can cause sleepiness (they are the active ingredient in many over-the-counter sleeping pills), but also may result in agitation and hallucinations.

Many drug companies sell products that contain combinations of medications. It is important to read the labels to make certain that the over-the-counter medication contains only the ingredients that are considered safe for infants and children.

There is a great temptation to try to relieve your infant or child's cold or cough symptoms because runny, stuffy noses, red eyes, and general congestion make for unhappy babies and kids. Unfortunately, the answer is not in a pill or liquid medication. The key to help relieve and reduce symptoms of cold or cough in your baby or child is with natural home remedies like keeping them hydrated and lubricating the nasal and sinus passages.

Regardless of age, when suffering from a cold and cough, keep well hydrated by drinking plenty of fluids. This helps clear excess mucus in the sinuses. Moreover, sticky, thick secretions are tougher to swallow, and can accumulate in the back of the throat, triggering a reflex cough mechanism.

Saline drops or sprays also can help loosen secretions from a cold, and lubricate the nasal and sinus passages. Saline drops or sprays are composed of salt water so there is no medication in the product. These drops are very helpful in assisting infants clear their noses. For those too young to blow their nose, a combination of saltwater drops with bulb syringe suction can help open clogged nasal passages.

Elevating the head of the bed will help prevent pooling of postnasal drip secretions in the back of the throat, which can trigger the cough mechanism.

Acetaminophen (Tylenol, Panadol), ibuprofen (Motrin, Advil) may be used for fever and pain. Do not give aspirin to infants younger than 6 months of age because of a complication called Reye's syndrome.

In 2007, The FDA issued a public-health advisory about the use of cold medications in kids in warning of potential dangers of over-the-counter cold and cough medicines to children under 2 years of age. But even this recommendation can be confusing, since most pediatric medication dosing is based on weight, not age.

How much different is a child who is 2 years and 1 month old (25 months old), compared with an infant who is 1 year and 11 months old? At the time of the recommendation, the FDA was "committed" to studying the medications in kids aged 2-11, and praised drug companies for voluntarily printing on their labels that these medications should not be given to children under 4 years of age. Years later, the FDA is still studying the safety of cold medications in the pediatric population.

The bottom line is that infants, toddlers, and children get colds, they get cranky, and they can be miserable. As parents, we suffer along with our kids, and we want to make them feel better, and that is not always easy. Appropriate treatments for your infant or child's cough or cold include drinking plenty of fluids for hydration, control fever with over-the-counter pain and fever reducer medicine like Children's Aleve or Advil, humidify the air, and hug your child often. These treatments have no side effects and at the end of the day, a tincture of time and a little patience may be the best remedy.