SILENOR- doxepin hydrochloride tablet
Currax Pharmaceuticals LLC
|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: 10/2020|
|What is the most important information I should know about SILENOR?|
|SILENOR can cause serious side effects including:|
|After taking SILENOR, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with SILENOR. Reported activities include:
|Stop taking SILENOR and call your healthcare provider right away if you find out that you have done any of the above activities after taking SILENOR.
|Take SILENOR 30 minutes before bedtime. After taking SILENOR, you should only do activities needed to get ready for bed.|
|What is SILENOR?|
|SILENOR is a prescription medicine used to treat adults who have trouble staying asleep.|
|It is not known if SILENOR is safe and effective in children.|
|Do not take SILENOR if you:
|Before taking SILENOR, tell your healthcare provider about all of your medical conditions, including if you:
|Tell your healthcare provider about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements.|
|SILENOR and other medicines may affect each other causing side effects. SILENOR may affect the way other medicines work, and other medicines may affect how SILENOR works.|
|Especially tell your healthcare provider if you take:
|Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.|
|How should I take SILENOR?
|What should I avoid during treatment with SILENOR?
|What are the possible side effects of SILENOR?|
|SILENOR can cause serious side effects including:
|The most common side effects of SILENOR include:|
|SILENOR may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.|
|These are not all of the possible side effects of SILENOR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|How should I store SILENOR?
|Keep SILENOR and all medicines out of the reach of children.|
|General Information about the safe and effective use of SILENOR.|
|Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SILENOR for a condition for which it was not prescribed. Do not give SILENOR 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 SILENOR that is written for healthcare professionals.|
|What are the ingredients in SILENOR?|
|Active Ingredient: doxepin hydrochloride|
|Inactive Ingredients: microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No. 1. The 6 mg tablet also contains FD&C Yellow No. 10 and FD&C Blue No. 1.|
|Distributed by: Currax™ Pharmaceuticals LLC, Morristown, NJ 07960 USA
For more information, contact Currax Pharmaceuticals LLC at 1-800-793-2145.