Label Changes for:
Vibramycin Monohydrate (doxycycline monohydrate) for Oral SuspensionVibramycin Hyclate (doxycycline hyclate capsules, USP) CapsulesVibramycin Calcium (doxycycline calcium oral suspension) SyrupVibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Revisions to the language related to benign intracranial hypertension
- Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)