FDA Requires New Drug Safety Labels for Medicines Containing Opioids to Eliminate Pediatric Use

Every day brings new headlines about the devastating opioid epidemic sweeping the nation, and the mounting death toll left in its wake. In an effort to address the use and abuse of opioids, the U. S. Food and Drug Administration (FDA) issued a Drug Safety Communication requiring new drug safety labeling changes on cough and cold medicines containing opioids.

A panel of experts assembled by the FDA concluded codeine and hydrocodone, both narcotic medicines known as opioids, are too dangerous for use by children under 18 years of age, and their risks outweigh the benefits for pediatric uses. The FDA is ordering safety-labeling changes on all prescription cough and cold medicines containing codeine and hydrocodone to prevent use by infants and children under 18 years old.

The FDA recommends that parents and caregivers

  • Always read the drug safety label before giving cough and cold medicines to children to ensure it does not contain codeine or hydrocodone.
  • When a prescription is given, ask the healthcare provider to confirm it does not contain opioids before filling it.
  • If you are unsure after reading the drug label whether the medication contains codeine or hydrocodone, call your pharmacist or healthcare provider before giving the medication to your child.
  • For nursing mothers, do not breastfeed if you’re taking medicine that contains codeine or hydrocodone because the harmful affects of these opioids can pass through your breast milk to your baby.

The FDA advises parents, caregivers, and healthcare providers that alternative over-the-counter (OTC) cough and cold treatments are available for children that do not contain opioids including products that contain dextromethorphan, or prescription medicines with bezonatate that can treat cough and cold without the risks associated with opioids.

The FDA is also ordering updated drug safety labels for adult use of medicines containing opioids. The FDA will now require a Boxed Warning, its strongest warning on drug safety labels, on all prescription drugs containing codeine and hydrocodone. The Boxed Warning will caution adults of the increased risk of breathing problems such as slowed or difficulty breathing, abuse, misuse, addiction, overdose, and death, when using products containing opioid medications.

List of Prescription Cough and Cold Medicines Containing Codeine

Active Ingredient(s) Brand Name(s)
codeine, chlorpheniramine Tuxarin ER, Tuzistra XR
codeine, phenylephrine, promethazine Only generics available
codeine, promethazine Only generics available
codeine, pseudoephedrine, tripolidine Triacin C


List of Prescription Cough and Cold Medicines Containing Hydrocodone

Active Ingredient(s) Brand Name(s)
hydrocodone, guaifenesin FlowTuss, Obredon
hydrocodone, pseudoephedrine, guaifenesin Hycofenix, Rezira
hydrocodone, chlorpheniramine Tussionex Pennkinetic, Vituz
hydrocodone, chlorpheniramine, pseudoephedrine Zutripro
hydrocodone, homatropine Only generics available

(Source: FDA Drug Safety Communication, 01/11/2018)

Please Report Side Effects and Adverse Reactions to Medications

The FDA urges patients and healthcare providers to report any side effects or adverse reactions associated with taking these products through its FDA MedWatch Safety Information and Adverse Event Reporting Program. You can submit an online form at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home or call 1-800-332-1088 for further information about how to obtain a form and submit it via fax or through the mail.

The FDA relies on patients and their healthcare providers to report any side effects or adverse reactions suffered from taking opioids or any medications so the FDA can investigate and take action either to alter safety labeling to warn about unknown side effects, add Boxed Warnings to alert consumers to potential dangers, or to remove a dangerous product from the market.