Metaxalone is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) in the brain.

Metaxalone is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.

Metaxalone may also be used for purposes not listed in this medication guide.

You should not use metaxalone if you have anemia (low red blood cells), or severe kidney or liver disease.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using metaxalone.

Metaxalone is only part of a complete treatment program that may also include rest, physical therapy, or other pain relief measures. Follow your doctor's instructions.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Muscle Spasm:

800 mg orally 3 to 4 times a day

Usual Pediatric Dose for Muscle Spasm:

12 years or older:
800 mg orally 3 to 4 times a day

You should not use metaxalone if you are allergic to it, or if you have:

• anemia (low red blood cells);

• severe kidney disease; or

• severe liver disease.

To make sure metaxalone is safe for you, tell your doctor if you have liver or kidney disease.

It is not known whether metaxalone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether metaxalone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Metaxalone is not approved for use by anyone younger than 12 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of metaxalone can be fatal.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with metaxalone. Check your food and medicine labels to be sure these products do not contain alcohol.

metaxalone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Dizziness or drowsiness may be more likely in older adults.

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

Metaxalone may cause serious side effects. Stop using metaxalone and call your doctor at once if you have:

• weak or shallow breathing;

• a light-headed feeling, like you might pass out;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness; or

• upper stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes).

Common side effects of metaxalone may include:

• dizziness, drowsiness;

• nausea, vomiting, upset stomach;

• headache; or

• feeling nervous or irritable;

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 metaxolone with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with metaxalone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Keep all appointments with your doctor.

Do not let anyone else take your medications. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.