Cough And Cold Medicine Over-The-Counter (OTC)

For many years over-the-counter (OTC) medications have been used safely to treat coughs and colds in adults. But even though studies were not done in children younger than 12 years old, these same medicines were made into cough and cold products for children. In the past 37 years, there have been over 100 deaths related to these medicines not being used properly. Most of the deaths were in children under 2 years old. OTC cough and cold medicines also caused over 1500 emergency room visits for children in the past 2 years.

What the FDA and American Academy of Pediatrics (AAP) Say

  • Cough and cold medicines should not be used in children younger than 4 years of age.
  • These medicines are not safe if:
    • Your child receives a dose that is too high for age and weight.
    • The medicine is given too often.
    • Your child receives more than 1 product that has the same medicine.
  • These medicines may be used in children 6 years old and older.

The FDA also told the companies that cough and cold medicine labels may not say, “consult your physician” for a dose for young children. This change will result in the following:

  • Changes in product labels, stating the new age limit
  • New child-resistant packaging
  • New measuring devices

Parents should follow the directions on the label of the medicine they have. Talk to your child’s doctor or pharmacist if you have questions.

The Medicines In Question

See if you have products containing any of these medications. If so, ask your doctor or pharmacist before giving them to your child. See the table of medicines in question below.

Generic name Class Uses

A Few Typical
Product Names

Guafenisen Expectorant ‘Wet’ coughs/mucus Mucinex®, Robitussin®
Dextromethorphan Cough
Reduce coughs Robitussin®; anything with
‘DM’ in the name
Antihistamine Allergies, itchiness Benadryl®, Chlor-Trimeton®
Decongestant Nasal stuffiness
congestion or pain
Sudafed®, Sudafed PE®,
Claritin D®

What You Can Do for a Cold or Cough

  • Have your child drink plenty of fluids, mainly water or flavored water. Limit fruit juice so your child does not develop diarrhea.
  • Your child should get plenty of sleep.
  • Use saline nasal spray and a bulb syringe to help congestion before eating or sleeping.
  • Use a cool mist humidifier in your child’s room. Do not use a warm humidifier; it can cause burns.
  • Older children can gargle with warm salt water (use table salt) to soothe a sore throat.
  • Give non-medicated lozenges for older children.

Approved Medications

You may still use these medicines to help bring down a fever or help with aches and pains. Be sure to read the label and give the correct dose.

do not give your children medication containing asprin

  • Acetaminophen (a-SEET-uh-MIN-o-fin) (Children’s/Infant’s Tylenol®)
  • Ibuprofen (eye-byoo-PRO-fen) (Children’s or Infant’s Motrin® or Advil®)
  • Do not give your child aspirin or products that contain aspirin (see Picture 1).
  • Do not give your child medicine labeled for use by adults.
  • Always read drug facts on the label for “active ingredients.” This will help you understand what the medicine is for. It will also help you make sure you are not giving the same type of medicine if you are using more than one product.

When to Call the Doctor

Call your child’s doctor if:

  • Your child is hoarse, cannot talk or complains of a sore throat
  • Your child pulls his ears or rolls his head from side to side
  • Your infant refuses to take liquids for 4 or more hours
  • Your child has fever over 103ºF rectally, 102ºF by mouth or 101ºF axillary (under the arm) that you cannot bring down after 1 or 2 days
  • Child doesn’t feel like playing or does not “act right”
  • Your child’s color changes to grayish blue or is very pale
  • Sickness lasts more than 10 days

These Helping Hands are also available to help you care for your child:

If you have any questions, be sure to ask your doctor or nurse.

Cough and Cold Medication Over-The-Counter (OTC) (PDF)

HH-V-225 2/09 Revised 12/12 Copyright 2009-2012, Nationwide Children's Hospital