Yes. 59 FDA-approved labels for Promethazine carry a boxed warning, and its subject is promethazine hydrochloride tablets, usp should not be used in pediatric patients less than 2 years of age because. A boxed warning is the most serious warning the FDA requires on a prescription label. It is applied to the drug and to the situations in which it is used, not to any particular person taking it.
What the warning says
Below is how the Promethazine warning opens on one specific label, identified underneath it. Of the 25 Promethazine labels sampled, 10 carried materially different wordings and this was the most common, used by 8 of them.
PROMETHAZINE HYDROCHLORIDE TABLETS, USP SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE TABLETS, USP IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE TABLETS, USP HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TABLETS, USP TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER.
PROMETHAZINE HYDROCHLORIDE, Coupler LLC, label version effective 07 February 2025. Opening of the warning; read the full label on DailyMed.Why the wording differs between manufacturers
There is no single official text of a boxed warning. The FDA sets what a warning must cover, and each manufacturer writes its own label within that. Of the 25 Promethazine labels sampled for this page, 10 carried materially different wordings of the same warning, and the version quoted above was used by 8 of them.
The hazard does not change between those 10 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Promethazine or its risks having changed.
Promethazine is dispensed under 59 current FDA labels despite this warning, which is the point worth holding onto: a boxed warning is a disclosure requirement, not a verdict. What a boxed warning does and does not mean sets out the distinction.
Common questions
Does Promethazine have a black box warning?
Yes. 59 FDA-approved labels for Promethazine carry a boxed warning, and its subject is promethazine hydrochloride tablets, usp should not be used in pediatric patients less than 2 years of age because. A boxed warning is the strongest warning the FDA requires on a prescription label, and it is applied to the drug, not to any individual taking it.
What does the Promethazine boxed warning say?
The wording is set by each manufacturer within FDA requirements, so it varies. In the version quoted on this page, taken from a label effective 07 February 2025, the warning concerns promethazine hydrochloride tablets, usp should not be used in pediatric patients less than 2 years of age because. The full text is linked so the exact version can be read rather than summarised.
Does the Promethazine boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of promethazine hydrochloride tablets, usp should not be used in pediatric patients less than 2 years of age because to be communicated prominently so prescribers weigh it explicitly. Promethazine remains FDA-approved and is dispensed under 59 current labels. A boxed warning is a disclosure requirement, not a judgement that a drug should not be used.
Why do different pharmacies show different warning text for the same drug?
Because each manufacturer writes its own label within the FDA's requirements. Of 25 Promethazine labels sampled here, 10 carried materially different wordings of the same warning. The hazard described is the same; the sentences are not. This is a common source of confusion when a prescription is refilled with a different manufacturer's product.
Should I stop taking Promethazine because of this warning?
This page does not answer that and cannot. The warning about promethazine hydrochloride tablets, usp should not be used in pediatric patients less than 2 years of age because is written for a prescriber deciding whether Promethazine suits a particular patient, and stopping a prescribed medicine carries its own risks that this page knows nothing about. Raise it with the prescriber or a pharmacist, who can see the whole picture.
Where this page's information comes from
The quotation above is from one Promethazine label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 59 labels, and the count of 10 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- PROMETHAZINE HYDROCHLORIDE prescribing information, Coupler LLC, effective 07 February 2025.
- openFDA drug labelling API, the source of the label counts and variant counts on this page.
Labels are revised over time. The version linked above is the one this page was written against, and a newer revision may differ. Counts reflect the labels present in openFDA on the retrieval date.