Orphenadrine-Aspirin-Caffeine

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.

Dry mouth, dizziness, drowsiness, lightheadedness, blurred vision, upset stomach, heartburn, nausea, vomiting, constipation, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that this medication has been prescribed because your doctor 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: mental/mood changes (such as confusion, anxiety, hallucinations, nervousness, agitation), shaking (tremor), fast/pounding/irregular heartbeat, hearing changes (such as ringing in the ears, difficulty hearing), difficulty urinating, easy bleeding/bruising, fainting, eye pain, unusual tiredness, signs of kidney problems (such as change in the amount of urine), yellowing eyes/skin, dark urine.

This drug may rarely cause serious bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, stop taking this medication and get medical help right away: stomach/abdominal pain that doesn't go away, black stools, vomit that looks like coffee grounds.

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: fever, swollen lymph nodes, 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 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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

Before taking this product, tell your doctor or pharmacist if you are allergic to orphenadrine, aspirin, or caffeine; or to other nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib); or to other salicylates (such as choline salicylate); 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: high pressure in the eye (glaucoma), stomach/intestine/esophagus problems (such as ulcers, blockage, difficulty swallowing, heartburn), difficulty urinating (such as due to enlarged prostate), a certain type of muscle/nerve disease (myasthenia gravis), asthma (including a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), growths in the nose (nasal polyps), bleeding/blood clotting problems (such as hemophilia, thrombocytopenia), gout, heart problems (such as fast/irregular heartbeat, heart failure, heart attack), high blood pressure, kidney disease, liver disease, mental/mood disorders (such as anxiety, nervousness), certain enzyme deficiencies (such as pyruvate kinase or G6PD deficiency).

This drug may make you dizzy or drowsy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

This drug contains aspirin. Children and teenagers younger than 18 years 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 confusion, stomach ulcer/bleeding, constipation, drowsiness, or trouble urinating. Confusion and drowsiness can increase the risk of falling.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

This medication passes into breast milk and may harm a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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 are: dichlorphenamide, methotrexate, mifepristone, vemurafenib.

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac, naproxen). These drugs are similar to this medication and may increase your risk of side effects if taken together. Ask your doctor or pharmacist for more details.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

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 medical/lab tests (such as dipyridamole-thallium imaging tests, certain urine tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: unusual excitement, fast/irregular heartbeat, seizures, rapid breathing, mental/mood changes (such as confusion), change in the amount of urine.

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 tells you to. A different medication may be necessary in that case.

If you are taking this medication for a long time, lab and/or medical tests (such as liver/kidney function, blood count) may be done. Keep all medical and lab appointments. Consult your doctor for more details.

If you are taking this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

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.