September 16, 2009 — The US Food and Drug Administration (FDA) is requiring manufacturers of the injectable form of promethazine hydrochloride to add a boxed warning to the drug's labeling that ...

The FDA has notified healthcare professionals that a Boxed Warning is being added to the prescribing information for promethazine hydrochloride products, describing the risks of severe tissue injury, ...

Jan. 4, 2006 — The US Food and Drug Administration (FDA) approved in November 2005 first-time generic formulations of promethazine HCl 12.5-, 25-, and 50-mg tablets for approved indications in ...

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. DBL Promethazine Hydrochloride Injection BP contains the active ...

An old drug with a wide range of uses now has a new FDA alert that could spare patients from some severe reactions. The FDA communication covers promethazine hydrochloride, a medicine approved for ...