TEMAZEPAM- temazepam capsule
Aphena Pharma Solutions - Tennessee, LLC
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TEMAZEPAM Capsules, USP C-IV
(temazepam)
Read the Medication Guide that comes with TEMAZEPAM before you start taking it 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.
What is the most important information I should know about TEMAZEPAM?
After taking TEMAZEPAM, 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 TEMAZEPAM. Reported activities include:
Call your doctor right away if you find out that you have done any of the above activities after taking TEMAZEPAM.
Important:
What is TEMAZEPAM?
TEMAZEPAM is a sedative-hypnotic (sleep) medicine. TEMAZEPAM is used in adults for the short-term (usually 7 to 10 days) treatment of a sleep problem called insomnia. Symptoms of insomnia include:
TEMAZEPAM is not for children.
TEMAZEPAM is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep TEMAZEPAM in a safe place to prevent misuse and abuse. Selling or giving away TEMAZEPAM 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 TEMAZEPAM?
Do not take TEMAZEPAM if you are pregnant or planning to become pregnant. TEMAZEPAM may cause birth defects or harm a fetus (unborn baby).
TEMAZEPAM may not be right for you. Before starting TEMAZEPAM, 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 with each other, sometimes causing serious side effects. Do not take TEMAZEPAM 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 TEMAZEPAM?
What are the possible side effects of TEMAZEPAM?
Possible serious side effects of TEMAZEPAM 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 TEMAZEPAM.
The most common side effects of TEMAZEPAM are:
These are not all the side effects of TEMAZEPAM. Ask your doctor or pharmacist for more information.
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 TEMAZEPAM?
General Information about TEMAZEPAM
This Medication Guide summarizes the most important information about TEMAZEPAM. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about TEMAZEPAM that is written for healthcare professionals.
What are the ingredients in TEMAZEPAM?
7.5mg, 15mg, 22.5mg and 30mg Capsules
Active Ingredient: temazepam USP
7.5 mg Capsules
Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide.
May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.
15 mg Capsules
Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide.
May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.
22.5 mg Capsules
Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide.
May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.
30 mg Capsules
Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide.
May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.
Manufactured by:
Novel Laboratories, Inc
Somerset, NJ 08873
Distributed by:
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA
31
NIN-123-04
Rev: 04/12