Librax is a capsule containing a combination of chlordiazepoxide and clidinium. Chlordiazepoxide is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Clidinium reduces stomach acid and decreases intestinal spasms.

Librax is a prescription medicine that may be effective in treating emotional distress caused by having a stomach disorder (such as an ulcer, irritable bowel syndrome, or intestinal infection).

Librax is given together with other medications to treat these conditions.

It is not known if Librax is safe and effective in children.

Librax can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

You should not use Librax if you have glaucoma, an enlarged prostate, or problems with urination.

Do not stop using this medicine without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Do not use Librax if you are allergic to chlordiazepoxide or clidinium, or to other benzodiazepines, such as alprazolam (Xanax), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax). Chlordiazepoxide and clidinium can cause birth defects in an unborn baby. Do not use this medicine if you are pregnant.

Get medical help right away if you stop using this medicine and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Do not drink alcohol while taking Librax. This medication can increase the effects of alcohol. Librax can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. This medication may be habit-forming and should be used only by the person it was prescribed for.

Take Librax exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Librax is usually taken before meals and at bedtime. Follow your doctor's instructions.

Call your doctor if your symptoms do not improve, or if they get worse.

Do not stop using this medicine without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Store Librax at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.

Usual Adult Dose for Peptic Ulcer:

Chlordiazepoxide 5 mg-clidinium 2.5 mg capsules:
Maintenance dose: 1 to 2 capsules orally 3 to 4 times a day.

Usual Adult Dose for Irritable Bowel Syndrome:

Chlordiazepoxide 5 mgclidinium 2.5 mg capsules:
Maintenance dose: 1 to 2 capsules orally 3 to 4 times a day.

Usual Adult Dose for Enterocolitis:

Chlordiazepoxide 5 mgclidinium 2.5 mg capsules:
Maintenance dose: 1 to 2 capsules orally 3 to 4 times a day.

Usual Geriatric Dose for Peptic Ulcer:

Chlordiazepoxide 5 mgclidinium 2.5 mg capsules:
Initial dose: 1 capsule orally 2 times a day, increasing the dose gradually as needed and tolerated.

Usual Geriatric Dose for Irritable Bowel Syndrome:

Chlordiazepoxide 5 mgclidinium 2.5 mg capsules:
Initial dose: 1 capsule orally 2 times a day, increasing the dose gradually as needed and tolerated.

Usual Geriatric Dose for Enterocolitis:

Chlordiazepoxide 5 mgclidinium 2.5 mg capsules:
Initial dose: 1 capsule orally 2 times a day, increasing the dose gradually as needed and tolerated.

You should not use Librax if you are allergic to chlordiazepoxide or clidinium, or if you have:

• glaucoma;

• an enlarged prostate; or

• a bladder obstruction or other urination problems.

To make sure Librax is safe for you, tell your doctor if you have ever had:

• eye problems;

• urination problems;

• bleeding problems;

• liver or kidney disease;

• drug or alcohol addiction; or

• depression, mental illness, or suicidal thoughts.

Tell your doctor if you are pregnant or plan to become pregnant. Chlordiazepoxide and clidinium may harm an unborn baby. Avoid taking this medicine during the first trimester of pregnancy.

Ask a doctor if it is safe to breastfeed while using this medicine. Librax can slow breast milk production.

Librax is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Librax can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include dry mouth, blurred vision, urinating less, constipation, extreme drowsiness, confusion, muscle weakness, or loss of consciousness.

Avoid drinking alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction to Librax: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Librax can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• severe drowsiness, slurred speech;

• slow heart rate, slow breathing (breathing may stop);

• a seizure;

• problems with memory or concentration;

• unusual changes in mood or behavior, thoughts of suicide or hurting yourself;

• problems with balance or muscle movement;

• confusion, paranoia, anger, aggression; or

• stomach pain, loss of appetite.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common Librax side effects may include:

• dry mouth;

• blurred vision;

• constipation, nausea;

• urination problems;

• confusion, drowsiness, loss of coordination;

• rash;;

• swelling;

• irregular menstrual periods; or

• increased or decreased interest in sex.

After you stop using this medicine, get medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.

Some withdrawal symptoms may last up to 12 months or longer after stopping this medicine suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• medicine to treat a mental illness; - promethazine, thioridazine, and others; o

• an MAO inhibitor - isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

This list is not complete. Other drugs may interact with chlordiazepoxide and clidinium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.