Over-the-counter cold medicines not for kids under 4, manufacturers agree

Children under the age of four with colds should not be given over-the-counter cough and cold medicines, according to new labeling that will go on the products.

Manufacturers of the nonprescription cough and cold remedies agreed to make the change in labeling after long negotiations with federal regulators.

Earlier this year, the US Food and Drug Administration (FDA) issued a warning that infants and children under 2 years of age should not be given cough and cold medicines, including decongestants for a stuffy nose, expectorants for loosening mucus, antihistamines for sneezing and runny nose and antitussives for quieting cough.

The FDA issued the warning after an expert advisory panel said there was insufficient evidence the drugs were safe and effective in treating children.

The drugs have been linked to serious side effects, including convulsions, rapid heart rates and death.

The FDA has been pressed to ban the use of the drugs for children under the age of 12. 

In its Consumer Update issued earlier this year warning against the use of over-the-counter cough and cold medicines for treating a colds in infants and children under 2 years of age, FDA advises: 

A cold is a respiratory illness that is usually self-limited and lasts about a week. Cold symptoms typically include sneezing, coughing, runny or stuffy nose, and sore throat. Children may also experience a fever. Most of the time, a cold will go away by itself. If you are concerned about making your child feel more comfortable, talk with your doctor about what approaches to take. Your doctor may recommend drinking plenty of fluids to help loosen mucus and keep children hydrated, and using saline nasal drops and gently suctioning mucus from the nose with a bulb syringe. Your doctor may also recommend fever reducers such as acetaminophen or ibuprofen. If your child’s cold symptoms do not improve or get worse, contact your doctor. A persistent cough may signal a more serious condition such as bronchitis or asthma.

To learn more:

• Read the FDA’s Consumer Update.
• Go to the National Library of Medicine’s information page on the common cold.
• Visit Seattle Children’s Health Advice webpage.

Tags: Colds, FDA, Flu, Nonprescription Drugs, Over-the-counter Drugs

Category: Child & Youth Health, Drugs & Medicines, Ear, Nose & Throat, Infections, Lungs & Breathing, Newborn and Infant Health, Uncategorized