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ALPRAZOLAM EXTENDED RELEASE- alprazolam tablet, extended release


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Alprazolam Extended-release Tablets?
  3. What Are Alprazolam Extended-release Tablets?
  4. Do Not Take Alprazolam Extended-release Tablets If:
  5. Alprazolam Extended-release Tablets May Cause Serious Side Effects, Including:
  6. Active Ingredient:
  7. Inactive Ingredients:

Patient Information 

Alprazolam (al pra' zoe lam)
Extended-Release Tablets, USP C-IV

What Is The Most Important Information I Should Know About Alprazolam Extended-release Tablets? 

  • Alprazolam extended-release tablets are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
  • Alprazolam extended-release tablets can make you sleepy or dizzy, and can slow your thinking and motor skills.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how alprazolam extended-release tablets affect you.
    • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking alprazolam extended-release tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, alprazolam extended-release tablets may make your sleepiness or dizziness much worse.
  • Do not take more alprazolam extended-release tablets than prescribed.

What Are Alprazolam Extended-release Tablets? 

  • Alprazolam extended-release tablets are a prescription medicine used to treat panic disorder, with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia)
  • Alprazolam extended-release tablets are a federal controlled substance (C-IV) because it can be abused or lead to dependence.Keep alprazolam extended-release tablets in a safe place to prevent misuse and abuse. Selling or giving away alprazolam extended-release tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • It is not known if alprazolam extended-release tablets are safe and effective in children.
  • Elderly patients are especially susceptible to dose related adverse effects when taking alprazolam extended-release tablets.
  • It is not known if alprazolam extended-release tablets are safe and effective for use longer than 8 weeks.

Do Not Take Alprazolam Extended-release Tablets If: 

  • you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in alprazolam extended-release tablets.

      • Alprazolam extended-release tablets can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how alprazolam extended-release tablets affect you.
      • You should not drink alcohol while taking alprazolam extended-release tablets. Drinking alcohol can increase your chances of having serious side effects.

Alprazolam Extended-release Tablets May Cause Serious Side Effects, Including: 

    • Store alprazolam extended-release tablets between 59 F to 86 F ( 15 C to 30 C)
    • Keep alprazolam extended-release tablets and all medicines out of the reach of children.

    General information about the safe and effective use of alprazolam extended-release tablets.

    • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
    • Do not use alprazolam extended-release tablets for a condition for which it was not prescribed.
    • Do not give alprazolam extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them.
    • You can ask your pharmacist or healthcare provider for information about alprazolam extended-release tablets that is written for health professionals. For more information call Actavis at 1-800-432-8534.

Active Ingredient: 

alprazolam, USP

Inactive Ingredients: 

lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Actavis Elizabeth LLC
Elizabeth, NJ 07207 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

40-9181

Revised May 2017



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