For oral administration, Robaxisal is available as a pink and white laminated tablet containing:

Methocarbamol, USP . 400 mg
Aspirin, USP   325 mg

Inactive Ingredients:   Corn Starch, FD&C Red 3, Magnesium Stearate, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Stearic Acid.

Methocarbamol has the following chemical name: 3-(2-Methoxyphenoxy)-1,2-propanediol 1-Carbamate

Last updated on RxList: 12/8/2004

Robaxisal is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.

Adults and children over 12 years of age: Two tablets four times daily. Three tablets four times daily may be used in severe conditions for one to three days in patients who are able to tolerate salicylates. These dosage recommendations provide respectively 3.2 and 4.8 grams of methocarbamol per day.

Robaxisal® is supplied as pink and white laminated, compressed tablets in bottles of 100 (NDC 0031-7469-63) and 500 (NDC 0031-7469-70).

Store at controlled room temperature, between 20° and 25°C (68° and 77°F).

Dispense in well-closed container.

Manufactured by:
Pharmaceutical Division
A.H. Robins Company
Richmond, VA 23220

Last updated on RxList: 12/8/2004

The most frequent adverse reaction to methocarbamol is dizziness or lightheadedness and nausea. This occurs in about one in 20-25 patients. Less frequent reactions are drowsiness, blurred vision, headache, fever, allergic manifestations such as urticaria, pruritus, and rash.

Adverse reactions that have been associated with the use of aspirin include: nausea and other gastrointestinal discomfort, gastritis, gastric erosion, vomiting, constipation, diarrhea, angio-edema, asthma, rash, pruritus, urticaria.

Gastrointestinal discomfort may be minimized by taking Robaxisal with food.

No Information Provided.

Last updated on RxList: 12/8/2004

Since methocarbamol may possess a general central nervous system depressant effect, patients receiving Robaxisal should be cautioned about combined effects with alcohol and other CNS depressants.

Products containing aspirin should be administered with caution to patients with gastritis or peptic ulceration, or those receiving hypoprothrombinemic anticoagulants.

Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

PREGNANCY

Safe use of Robaxisal has not been established with regard to possible adverse effects upon fetal development. Therefore, Robaxisal should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards.

NURSING MOTHERS

It is not known whether methocarbamol is secreted in human milk; however, aspirin does appear in human milk in moderate amounts. It can produce a bleeding tendency either by interfering with the function of the infant's platelets or by decreasing the amount of prothrombin in the blood. The risk is minimal if the mother takes the aspirin just after nursing and if the infant has an adequate store of vitamin K. As a general rule, nursing should not be undertaken while a patient is on a drug.

PEDIATRIC USE

Safety and effectiveness in children 12 years of age and below have not been established.

USE IN ACTIVITIES REQUIRING MENTAL ALERTNESS

Robaxisal may rarely cause drowsiness. Until the patient's response has been determined, he should be cautioned against the operation of motor vehicles or dangerous machinery.

Last updated on RxList: 12/8/2004

Toxicity due to overdosage of methocarbamol is unlikely; however, acute overdosage of aspirin may cause symptoms of salicylate intoxication.

TREATMENT OF

Supportive therapy for 24 hours, as methocarbamol is excreted within that time. If salicylate intoxication occurs, especially in children, the hyperpnea may be controlled with sodium bicarbonate. Judicious use of 5% CO ₂ with 95% O ₂ may be of benefit. Abnormal electrolyte patterns should be corrected with appropriate fluid therapy.

Hypersensitivity to methocarbamol or aspirin.

Last updated on RxList: 12/8/2004

ACTIONS

Robaxisal provides a double approach to the management of discomforts associated with musculoskeletal disorders.

METHOCARBAMOL

The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

ASPIRIN

Aspirin is a mild analgesic with anti-inflammatory and antipyretic activity.

Last updated on RxList: 12/8/2004

No Information Provided.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

METHOCARBAMOL/ASPIRIN - ORAL

(meth-oh-KARB-uh-mole/ASP-er-in)

USES: This combination medication is used to treat pain caused by or occurring with muscle spasm. Methocarbamol helps to relax the muscles. Aspirin helps to decrease the pain.

HOW TO USE: Take this medication by mouth with or without food, usually 4 times daily or as directed by your doctor. Take with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this medication. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid.

The dosage is based on your medical condition and response to treatment. Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Nausea, vomiting, stomach upset, heartburn, diarrhea, lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: hearing problems (e.g., ringing in the ears, hearing loss).

Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, change in the amount of urine, yellowing eyes/skin, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), fast/pounding heartbeat, persistent tiredness, easy bruising/bleeding.

This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: black stool, persistent stomach/abdominal pain, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to methocarbamol or aspirin; or to salicylates (e.g., salsalate) or nonsteroidal anti-inflammatory drugs (e.g., ibuprofen); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), stomach/intestinal ulcers, bleeding/blood clotting disorders (e.g., hemophilia, von Willebrand disease, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, certain enzyme deficiencies (pyruvate kinase or G6PD deficiency), heartburn, gout, asthma, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or taking part in any other activity that requires alertness. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye's syndrome, a rare but serious illness.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.

During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: ketorolac, mifepristone.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: ACE inhibitors (e.g., lisinopril, enalapril), acetazolamide, antacids, anti-seizure medications (e.g., phenytoin, valproic acid), "blood thinners" (e.g., warfarin, heparin, ticlopidine), certain diabetes drugs (sulfonylureas such as glyburide), certain drugs used to treat gout (uricosuric drugs such as probenecid, sulfinpyrazone), corticosteroids (e.g., dexamethasone), ginkgo biloba, lepirudin, methotrexate, pemetrexed, salicylates (e.g., salsalate), spironolactone, SSRI antidepressants (e.g., fluoxetine, fluvoxamine).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), other muscle relaxants, psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products, pain relievers/fever reducers) because they may contain aspirin and/or aspirin-related drugs (NSAIDs such as ibuprofen or naproxen) or ingredients that may cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including urine 5-HIAA/VMA tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, persistent nausea/vomiting, ringing in the ears.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.