Robaxisal (Methocarbamol and Aspirin)
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Robaxisal (Methocarbamol and Aspirin)

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

DRUG DESCRIPTION

For oral administration, Robaxisal (methocarbamol and aspirin) 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

What are the precautions when taking methocarbamol and aspirin (Robaxisal)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to methocarbamol or aspirin; or to nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), growths in the nose (nasal polyps), stomach/intestine/esophagus problems (such as ulcers, heartburn), kidney disease, liver disease, bleeding/blood clotting disorders (such as hemophilia, von Willebrand disease,...

Read All Potential Precautions of Robaxisal »

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

INDICATIONS

Robaxisal (methocarbamol and aspirin) 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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Robaxisal (methocarbamol and aspirin) ® 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 reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

SIDE EFFECTS

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 (methocarbamol and aspirin) with food.

Read the Robaxisal (methocarbamol and aspirin) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No Information Provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

WARNINGS

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

PRECAUTIONS

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 (methocarbamol and aspirin) has not been established with regard to possible adverse effects upon fetal development. Therefore, Robaxisal (methocarbamol and aspirin) 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 (methocarbamol and aspirin) 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 reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

OVERDOSE

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.

CONTRAINDICATIONS

Hypersensitivity to methocarbamol or aspirin.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

CLINICAL PHARMACOLOGY

ACTIONS

Robaxisal (methocarbamol and aspirin) 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 reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

PATIENT INFORMATION

No Information Provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

PATIENT INFORMATION

No Information Provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Disclaimer

Robaxisal Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

METHOCARBAMOL/ASPIRIN - ORAL

(meth-oh-KAR-ba-mol/AS-pir-in)

USES: This product is used to treat muscle spasm/pain. Methocarbamol helps to relax the muscles. Aspirin helps to decrease the pain.

HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 4 times daily (every 6 hours). Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication. If you have stomach upset while taking this medication, take it with food or milk.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

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.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Disclaimer

Robaxisal Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, stomach upset, nausea/vomiting, heartburn, or blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 right away if you have any serious side effects, including: easy bruising/bleeding, dark urine, yellowing eyes/skin, persistent nausea/vomiting, hearing problems (such as ringing in the ears, hearing loss), change in the amount of urine, fast/pounding heartbeat, unusual tiredness, fainting, mental/mood changes (such as confusion, forgetfulness).

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

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Robaxisal (methocarbamol and aspirin) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to methocarbamol or aspirin; or to nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), growths in the nose (nasal polyps), stomach/intestine/esophagus problems (such as ulcers, heartburn), kidney disease, liver disease, bleeding/blood clotting disorders (such as hemophilia, von Willebrand disease, thrombocytopenia), certain enzyme deficiencies (such as pyruvate kinase, G6PD deficiency), gout.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

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. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This drug contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.

Older adults may be more sensitive to the side effects of this drug, especially stomach ulcers.

Aspirin is not recommended for use during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. Do not use this medication during the last 3 months of pregnancy because of possible harm to the unborn baby or problems during delivery. Consult your doctor for more details.

It is unknown if methocarbamol passes into breast milk. Aspirin passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Disclaimer

Robaxisal Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: mifepristone, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel/ticagrelor, "blood thinners" such as warfarin, SSRI antidepressants such as fluoxetine).

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs if taken together with this medication may increase your risk of side effects. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), other muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

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

OVERDOSE: If overdose is suspected, contact a 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, ringing in the ears, seizures.

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 your doctor directs you to do so. 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 away from light and moisture. Do not store in the bathroom. Keep all medications 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.

Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Robaxisal Patient Information Including Side Effects

Brand Names: Robaxisal

Generic Name: aspirin and methocarbamol (Pronunciation: AS pir in/ meth oh KAR ba mall)

What is aspirin and methocarbamol (Robaxisal)?

Aspirin is in a class of drugs called salicylates. Aspirin works by reducing substances in the body that cause pain and inflammation. It is used to reduce pain, inflammation and fever.

Methocarbamol is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to the brain.

Aspirin and methocarbamol are used together, along with rest and physical therapy, to treat injuries and other painful muscular conditions.

Aspirin and methocarbamol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of aspirin and methocarbamol (Robaxisal)?

If you experience any of the following serious side effects, stop taking aspirin and methocarbamol and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • red, black, or bloody stools;
  • bloody vomit;
  • rash or itching;
  • fever; or
  • nasal congestion.

Other, less serious side effects may be more likely to occur. Continue to take aspirin and methocarbamol and talk to your doctor if you experience

  • drowsiness, dizziness, lightheadedness or fainting;
  • headache or blurred vision;
  • nausea, diarrhea, or a metallic taste in the mouth;
  • brown, black, or green urine (this is not harmful); or
  • faint ringing in the ears.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Read the Robaxisal (methocarbamol and aspirin) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about aspirin and methocarbamol (Robaxisal)?

Use caution when driving, operating machinery, or performing other hazardous activities. Aspirin and methocarbamol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking aspirin and methocarbamol. Also, in combination with aspirin, alcohol can be damaging to the stomach.

Call your doctor immediately if you experience a rash, itching, a fever, or nasal congestion during treatment with aspirin and methocarbamol.

Watch for bloody, black, or tarry stools or bloody vomit. This could indicate damage to the stomach.

Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

Side Effects Centers

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Robaxisal Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking aspirin and methocarbamol (Robaxisal)?

Before taking this medication, tell your doctor if you have

  • kidney disease,
  • liver disease,
  • a stomach or intestinal ulcer,
  • a bleeding or blood-clotting disorder.

You may not be able to take aspirin and methocarbamol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether aspirin and methocarbamol will be harmful to an unborn baby. Do not take aspirin and methocarbamol without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether aspirin and methocarbamol passes into breast milk.Do not take aspirin and methocarbamol without first talking to your doctor if you are breast-feeding a baby.

Do not use any medication that contains aspirin to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 20 years of age, aspirin may increase the risk of Reye's syndrome, a rare but often fatal condition.

How should I take aspirin and methocarbamol (Robaxisal)?

Take aspirin and methocarbamol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

Store aspirin and methocarbamol at room temperature away from moisture and heat.

Side Effects Centers

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Robaxisal Patient Information including If I Miss a Dose

What happens if I miss a dose (Robaxisal)?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose (Robaxisal)?

Seek emergency medical attention.

Symptoms of an aspirin and methocarbamol overdose include headache; ringing in the ears; dim vision; nausea; vomiting; diarrhea; sweating; increased thirst; low blood pressure (weakness, fainting, confusion); drowsiness; decreased breathing; and unconsciousness.

What should I avoid while taking aspirin and methocarbamol (Robaxisal)?

Use caution when driving, operating machinery, or performing other hazardous activities. Aspirin and methocarbamol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking aspirin and methocarbamol. Also, in combination with aspirin, alcohol can be damaging to the stomach.

What other drugs will affect aspirin and methocarbamol (Robaxisal)?

Drowsiness or dizziness caused by methocarbamol may be increased by other drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness and death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

Do not take aspirin and methocarbamol without first talking to your doctor if you are taking any of the following medicines:

  • an anticoagulant such as warfarin (Coumadin), heparin, enoxaparin (Lovenox), dalteparin (Fragmin), danaparoid (Orgaran), ardeparin (Normiflo), or tinzaparin (Innohep);
  • a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), diclofenac (Voltaren, Cataflam), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), or tolmetin (Tolectin); or
  • another salicylate such as aspirin (Acuprin, Ecotrin, Ascriptin, Bayer, others); choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

You may not be able to take aspirin and methocarbamol, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with aspirin and methocarbamol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has more information about aspirin and methocarbamol written for health professionals that you may read.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2009 Cerner Multum, Inc. Version: 4.01. Revision date: 8/10/04.

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