OXAZEPAM- oxazepam capsule 
TruPharma, LLC



Oxazepam (ox-AZE-e-pam) Capsules, USP  C-IV

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

Get emergency help right away if any of the following happens:

o shallow or slowed breathing

o breathing stops (which may lead to the heart stopping)

o excessive sleepiness (sedation).

Do not drive or operate heavy machinery until you know how taking oxazepam with opioids affects you.

Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Oxazepam, which can lead to overdose and serious side effects including coma and death.  

o Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Oxazepam. These serious side effects may include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.

o Take Oxazepam exactly as your healthcare provider prescribed.

o Do not share your Oxazepam with other people

o Keep Oxazepam in a safe place and away from children.

Physical dependence and withdrawal reactions.


o Do not suddenly stop taking Oxazepam.  Stopping Oxazepam suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions,  seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.

o Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.


Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

o Do not take more oxazepam than prescribed or take oxazepam for longer than prescribed.


What is oxazepam?

Do not take oxazepam  if you:

• are allergic to oxazepam or any of the ingredients in oxazepam capsules. See the end of this Medication Guide for a complete list of ingredients in oxazepam capsules.

Before you take oxazepam, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking oxazepam with certain other medicines can cause side effects or affect how well oxazepam or the other medicines work Do not start or stop other medicines without talking to your healthcare provider.

How should I take oxazepam?

What are the possible side effects of oxazepam?

Oxazepam may cause serious side effects, including:

Oxazepam can make you sleepy or dizzy and can slow your thinking and motor skills.

o Do not drive, operate heavy machinery, or do other dangerous activities until you know how oxazepam affects you.

o Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking oxazepam without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, oxazepam may make your sleepiness or dizziness much worse.

The most common side effects of oxazepam include:

  • drowsiness
  • dizziness
  • vertigo
  • headache

These are not all the possible side effects of oxazepam. 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 oxazepam?

General information about the safe and effective use of oxazepam capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use oxazepam for a condition for which it was not prescribed. Do not give oxazepam 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 oxazepam that is written for health professionals.

What are the ingredients in oxazepam?

Active ingredient: oxazepam

Inactive ingredients:

croscarmellose sodium, D&C yellow #10, FD&C blue #1, FD&C blue # 2, FD&C red # 40, ferric oxide black, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, sda-3a alcohol, shellac, sodium lauryl sulfate, titanium dioxide and other inert ingredients.

The 15 mg capsule also contains: FD&C yellow # 6.

The 30 mg also contains: D&C red # 28.

For more information, call TruPharma LLC at 1-877-541-5504

Manufactured by:

Frontida BioPharm, Inc. Philadelphia, PA 19124 USA

Distributed by:

TruPharma LLC, Tampa, FL 33609 USA

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

Issued: 02/05/2021

Rev 04, 02/2021

Revised: 4/2021
TruPharma, LLC