Medication Guide App

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

September 2013

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)

 

September 2013

PRECAUTIONS

General
  • Revisions to the language related to benign intracranial hypertension

ADVERSE REACTIONS

Immune
  • Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)
     
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