New FDA rules: No codeine or hydrocodone under 18

New FDA rules: No codeine or hydrocodone under 18

The Food and Drug Administration (FDA) says it is tightening restrictions on prescription cough and cold products containing codeine or hydrocodone to protect children under 18 from serious risks of harm.

Child being given a spoonful of medicineThe agency announced new safety labeling changes that limit such products to adults 18 years and older “because the risks of these medicines outweigh their benefits in children younger than 18.”

“We are taking this action after conducting an extensive review and convening a panel of outside experts,” the FDA announcement said. “Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.”

The new orders strengthen its ruling from last April, which tightened restrictions on two opioids, codeine and tramadol, that were widely-used to treat colds, coughs and pain in kids. In that ruling, kids under 12 were no longer allowed to receive codeine or tramadol at all.

Last April’s ruling also called for special screening for contraindications for teens 12 to 18, before prescribing either drug for any reason. At that time, the FDA said studies were continuing and that further restrictions were a possibility.

Consistent with existing opioid rules

The latest orders explain that new safety labeling changes will show that “these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older,” the FDA said.

The new rules are consistent with the safety issues described in the labels of other prescription opioid pain medicines. The new actions are for opioid cough and cold medicines requiring a prescription. Although cough formulations containing codeine are usually prescription-only, some codeine cough medicines are still available “over the counter” in a few states. The FDA says it is “considering regulatory action for these products.”

The following products are affected:

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

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


Hydrocodone, homatropine

Only generics available

The FDA said that “health care professionals should be aware that the FDA is changing the age range for which prescription opioid cough and cold medicines are indicated. These products will no longer be indicated for use in children, and their use in this age group is not recommended.

“Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated. For those children in whom cough treatment is necessary, alternative medicines are available. These include over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products.”

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