Skelaxin

Yes

Your pharmacist can provide more information about metaxalone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Serious side effects have been reported with Skelaxin. See the "Drug Precautions" section.

Side effects of Skelaxin include the following:

• dizziness 
• drowsiness
• headache
• nausea
• vomiting
• nervousness/irritability
• stomach upset

This is not a complete list of Skelaxin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• back or leg pains
• black, tarry stools
• bleeding gums
• chest pain
• chills
• cough
• dark urine
• difficulty in breathing or swallowing
• dizziness
• fast heartbeat
• fever
• general body swelling
• headache
• itching
• loss of appetite
• nausea or vomiting
• nosebleeds
• painful or difficult urination
• pale skin
• rash
• shortness of breath
• skin itching, rash, or redness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, throat, or tongue
• swollen glands
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood
• yellowing of the eyes or skin

• Hives
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest
• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• drowsiness
• irritability
• stomach cramps
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Skelaxin (metaxalone) is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.

SEALED FOR YOUR PROTECTION

Pfizer
NDC 60793-136-01

Skelaxin®
(metaxalone) tablets

800 mg

100 Tablets
Rx only

Take Skelaxin exactly as it was prescribed for you. 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 this medicine.

Skelaxin 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: 800 mg orally 3 to 4 times a day.

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

This medicine 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.