Label Changes for Children’s Cold Medications

By | 2022-02-08T14:45:55-05:00 November 17th, 2008|0 Comments

The Consumer Healthcare Products Association, an association that represents most of the manufacturers of nonprescription over-the-counter children’s cough and cold medicines, recently announced voluntarily product label modifications. The most significant change mandates a “do not use” warning for children under age 4. While OTC pediatric cough and cold medicines are generally recognized as safe and effective when used as directed, inappropriate use can result in serious adverse reactions or death.

Parent teaching: It’s important to explain to patients that there are no FDA-approved dosing recommendations for administering over-the-counter cough and cold medications to children under age 2. The proper dosage for infants and young children has not been studied. While new products will carry the more restrictive age recommendations, warn parents that older labels on products may still reflect use among younger children and infants upon the advice of a physician. Because the labeling change is voluntary, products with older labels will be allowed to remain on the shelves.

Some parents may continue to deliver small doses of cold medications to infants against label directions and without consulting their physicians. Remind parents that this practice can be extremely dangerous because the dosages at which cough and cold medications can cause illness or death in children younger than age 2 are not known.

When parents do seek caregiver advice, it’s crucial for them to divulge any over-the-counter combination medications already administered so that an overdose from multiple medications with the same ingredient can be avoided.

As an alternative to pseudoephedrine and other nasal decongestants, remind parents that nasal secretions in infants can also be removed with a rubber suction bulb. Secretions can be softened with saline nose drops or a cool-mist humidifier.

Caution: Review current drug information before administering and monitoring medications.

Drug News is compiled by Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, who maintains a private practice in Plantation, Fla., and is professor and area chair for nursing at the University of Phoenix, Fort Lauderdale.


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