Aspirin/Caffeine/Orphenadrine Citrate, Oral

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KEY POINTS

• This medicine is taken by mouth to relieve pain and inflammation, and relax your muscles. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: analgesic (pain reliever); skeletal muscle relaxant

Generic and brand names: aspirin/caffeine/orphenadrine, oral

What is this medicine used for?

This medicine is a combination of 3 medicines. Aspirin helps decrease pain and inflammation, caffeine helps increase the pain relieving effects of this medicine, and orphenadrine relaxes muscles. This medicine is usually used along with rest and physical therapy to relieve pain from sprains, spasms, or injuries.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• Adrenal gland problems such as Addison's disease
• Anemia or any bleeding disorder
• Asthma
• Diabetes
• Glaucoma
• Gout
• Heart problems
• Kidney or liver problems
• Low blood pressure
• Myasthenia gravis
• Nasal polyps
• Problems with alcohol or drug abuse
• Seizures
• Thyroid problems
• Trouble swallowing
• Trouble urinating or an enlarged prostate gland
• Ulcers

Tell your healthcare provider if you are taking any medicine that reduces the chance of blood clots forming, such as warfarin (Coumadin).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Your healthcare provider will adjust your dosage depending on how the medicine works for you. Do not take more or take it more often than directed because its side effects may increase.

Do not stop taking this medicine without your healthcare provider's approval. You must reduce your dosage gradually. If you suddenly stop taking this medicine it can cause very serious side effects.

Check with your healthcare provider before you give any medicine that contains aspirin or salicylates to a child or teen under age 18. Children and teens who take aspirin are at risk for a serious illness called Reye’s syndrome.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: headache, ringing in the ears, nausea, vomiting, diarrhea, dry mouth, weakness, confusion, slow or shallow breathing, seizures, cold, clammy skin, fainting, dizziness, fever, coma.

What should I watch out for?

This medicine may cause dizziness, drowsiness, or lack of coordination. Do not drive or operate machinery unless you are fully alert.

This medicine may make you feel dizzy or faint, especially when you get up from sitting or lying down. Getting up slowly may help.

This medicine may cause dry mouth. Use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. If dry mouth lasts longer than 2 weeks, tell your healthcare provider about it.

Do not take additional aspirin or products that contain aspirin unless directed to do so by your healthcare provider. This medicine also contains aspirin and it may increase your risk of bleeding. Taking an overdose can cause serious problems. If you think you have taken an overdose or notice any unusual bruising or bleeding, get medical care right away. If you are not sure about which products contain aspirin, ask your pharmacist.

Do not give medicines that contain aspirin to children and teenagers with flu symptoms or chickenpox without your healthcare provider's approval. It may lead to a rare but serious illness known as Reye’s syndrome.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

Contact your healthcare provider if your condition does not improve in a few days or if it gets worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Serious (Report these to your healthcare provider right away.): Trouble breathing, slow or shallow breathing, unusual bruising or bleeding, bloody or dark urine, black or tarry bowel movements, severe or ongoing heartburn or stomach pain (especially at night), severe nausea or vomiting, severe dizziness or fainting, ringing or buzzing in the ears, fast or irregular heartbeat, hallucinations (seeing or hearing things that are not there), severe muscle spasms or tremors, extreme tiredness or weakness, slurred speech, unusual nervousness, unexplained weight loss, trouble urinating.

Other: Constipation, diarrhea, nausea, vomiting, loss of appetite, heartburn, flushing, headache, trouble sleeping, drowsiness, dry mouth, blurred vision, dizziness, hiccups.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Abiraterone (Zytiga)
• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Acetazolamide (Diamox)
• Alcohol
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, risperidone (Risperdal), thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• Celecoxib (Celebrex)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Live flu vaccine (FluMist nasal spray)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as aminophylline, arformoterol (Brovana), fluticasone/salmeterol (Advair), formoterol (Perforomist), mometasone/formoterol (Dulera), salmeterol (Serevent), and theophylline
• Medicines to treat or prevent blood clots such as clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), heparin, pentoxifylline, prasugrel (Effient), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Methazolamide (Neptazane)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Muscle relaxants such as chlorzoxazone (Parafon Forte), cyclobenzaprine (Amrix), metaxalone (Skelaxin), methocarbamol (Robaxin), orphenadrine (Norflex), and tizanidine (Zanaflex)
• Narcotic cough, cold, or allergy medicines such as guaifenesin/codeine (Robitussin AC, Tussi-Organidin), hydrocodone/chlorpheniramine (Tussionex), hydrocodone/homatropine, promethazine, and promethazine with codeine (Phenergan with codeine)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Natural remedies such as alfalfa, anise, bilberry, bladderwrack, capsicum, cat's claw, celery, chamomile, coleus, dong quai, evening primrose, fenugreek, feverfew, garlic, ginger, ginkgo, ginseng, glucosamine, goldenseal, gotu kola, grape seed, green tea, horse chestnut, kava, lemon balm, licorice, papain, passionflower, prickly ash, red clover, SAMe, St. John's Wort, turmeric, valerian, and willow
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other medicines that contain salicylates such as Alka Seltzer and Pepto Bismol
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pralatrexate (Folotyn)
• Probenecid
• Prochlorperazine (Compro)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), flurazepam, phenobarbital, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants and diet pills such as amphetamine/dextroamphetamine (Adderall), armodafinil (Nuvigil), dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), and modafinil (Provigil)
• Varicella (chickenpox) vaccine or varicella zoster (shingles) vaccine

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.