Metaxall

• It is used to calm muscles.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Metaxall affects you.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• This medicine is used with rest, PT (physical therapy), pain drugs, and other therapies.
• If you have high blood sugar (diabetes), talk with your doctor about which glucose tests are best to use.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Metaxall while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Headache.
• Feeling nervous and excitable.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Metaxalone is available as an 800 mg, light pink to pink, capsule shaped, scored uncoated tablet.

Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is:

Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water.

Each tablet contains 800 mg metaxalone and the following inactive ingredients: calcium carbonate, FD& C Red # 40, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, silicone dioxide, sodium starch glycol ate and sodium stearyl fumarate.

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

NDC 51021-333-60

Metaxall™
Metaxalone 800mg tablets

Rx only

SEALED FOR YOUR PROTECTION

60 tablets

SIRCLE
Laboratories

Animal reproduction studies have not revealed evidence of impaired fertility or harm to the fetus. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Safety has not been established during pregnancy. US FDA pregnancy category: Not assigned

Safety has not been established. Excreted into human milk: Unknown Excreted into animal milk: Data not available