SECONAL SODIUM- secobarbital sodium capsule
Bausch Health US, LLC
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MEDICATION GUIDE
SEDATIVE-HYPNOTIC CAPSULES C-II
SECONAL SODIUM® CII
(secobarbital sodium)
CAPSULES, USP
Rx only
Read this Medication Guide before you start taking a SEDATIVE-HYPNOTIC and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. You and your doctor should talk about the SEDATIVE-HYPNOTIC when you start taking it and at regular checkups.
What is the most important information I should know about SEDATIVE-HYPNOTICS?
After taking a SEDATIVE-HYPNOTIC, 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 a SEDATIVE-HYPNOTIC. Reported activities include:
Important:
What are SEDATIVE-HYPNOTICS?
SEDATIVE-HYPNOTICS are sleep medicines. SEDATIVE-HYPNOTICS are used in adults for the short-term treatment of the symptom of trouble falling asleep from insomnia. SEDATIVE-HYPNOTICS do not treat other symptoms of insomnia which include waking up too early in the morning and waking up often during the night.
SEDATIVE-HYPNOTICS are not for children.
SEDATIVE-HYPNOTICS are federally controlled substances (Secobarbital Sodium Capsule is a C-II) because they can be abused or lead to dependence. Keep SEDATIVE-HYPNOTICS in a safe place to prevent misuse and abuse. Selling or giving away SEDATIVE-HYPNOTICS may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. |
Who should not take SEDATIVE-HYPNOTICS?
Do not take SEDATIVE-HYPNOTICS if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Secobarbital Sodium Capsules.
Symptoms of a serious allergic reaction to secobarbital can include:
SEDATIVE-HYPNOTICS may not be right for you. Before starting SEDATIVE-HYPNOTICS, tell your doctor about all of your health conditions, including if you:
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact, sometimes causing side effects. Do not take SEDATIVE-HYPNOTICS with other medicines that can make you sleepy.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take SEDATIVE-HYPNOTICS?
What are the possible side effects of SEDATIVE-HYPNOTICS?
Serious side effects of SEDATIVE-HYPNOTICS include:
Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using the SEDATIVE-HYPNOTIC.
Common side effects of SEDATIVE-HYPNOTICS include:
These are not all the side effects of SEDATIVE-HYPNOTICS. Ask your doctor or pharmacist for more information.
How should I store SEDATIVE-HYPNOTICS?
General Information about SEDATIVE-HYPNOTICS
This Medication Guide summarizes the most important information about SEDATIVE-HYPNOTICS. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about the SEDATIVE-HYPNOTIC that was written for healthcare professionals.
If you would like more information, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What are the ingredients in the SEDATIVE-HYPNOTIC?
Active Ingredient: Secobarbital Sodium
Inactive Ingredients: dimethicone, FD&C Red No. 3, FD&C Yellow No. 10, gelatin, magnesium stearate, pregelatinized starch and titanium dioxide.
Seconal and Seconal Sodium are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates
©Valeant Pharmaceuticals North America LLC
Distributed by:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
This Medication Guide has been approved by the US. Food and Drug Administration.
November 2015
9478900