Robaxisal

(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 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...

Read All Potential Side Effects and See Pictures of Robaxisal

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 salicylates (e.g., salsalate) or nonsteroidal anti-inflammatory drugs (e.g., 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.

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,...

Read All Potential Precautions of Robaxisal


Robaxisal Consumer (continued)

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 (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.

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 product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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. Do not drive, use machinery, or do any activity that requires alertness 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. 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.


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)?
  • What are the possible side effects of aspirin and methocarbamol (Robaxisal)?
  • What is the most important information I should know about aspirin and methocarbamol (Robaxisal)?
  • What should I discuss with my healthcare provider before taking aspirin and methocarbamol (Robaxisal)?
  • How should I take aspirin and methocarbamol (Robaxisal)?
  • What happens if I miss a dose (Robaxisal)?
  • What happens if I overdose (Robaxisal)?
  • What should I avoid while taking aspirin and methocarbamol (Robaxisal)?
  • What other drugs will affect aspirin and methocarbamol (Robaxisal)?
  • Where can I get more information?

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.

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.

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