Dispense in tight container (USP).

Suspension 100 mg/5 mL (teaspoon) –  yellow-orange, citrus-vanilla flavored

Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83

Shake well before using.

Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).

*Thorazine ® is a registered trademark of GlaxoSmithKline.

T2015-136
September 2015

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MEDICATION GUIDE

TEGRETOL® and TEGRETOL®-XR (Teg-ret-ol)

(carbamazepine)

Tablets, Suspension, Chewable Tablets, Extended-Release Tablets

Read this Medication Guide before you start taking Tegretol or Tegretol–XR (TEGRETOL) and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about TEGRETOL?

Do not stop taking TEGRETOL without first talking to your healthcare provider.

Stopping TEGRETOL suddenly can cause serious problems.

TEGRETOL can cause serious side effects, including:

1.TEGRETOL may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking TEGRETOL within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take TEGRETOL to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:
skin rash
hives
sores in your mouth
blistering or peeling of the skin
2.TEGRETOL may cause rare but serious blood problems. Symptoms may include:
fever, sore throat, or other infections that come and go or do not go away
easy bruising
red or purple spots on your body
bleeding gums or nose bleeds
severe fatigue or weakness
3.Like other antiepileptic drugs, TEGRETOL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dying
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled.
      Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

      Do not stop TEGRETOL without first talking to a healthcare provider.

      Stopping TEGRETOL suddenly can cause serious problems. You should talk to your healthca