Orphenadrine w/A.C. (Oral)

Orphenadrine, aspirin, and caffeine combination is used to relieve mild to moderate pain in patients with acute (short-term) muscle or bone problems. It helps relax certain muscles in your body, which eases the pain and discomfort caused by strains, sprains, or other injuries to your muscles. However, this medicine does not replace rest, exercise, or other treatments that your doctor may recommend for your medical issue.

Orphenadrine works in the central nervous system (CNS) to create its muscle relaxant effects. Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) that relieves pain and lowers fever. Caffeine is a CNS stimulant that is used along with pain relievers to enhance their effect.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor your or your child's progress, especially if you will be using this medicine for a long time. This will help your doctor see if the medicine is working properly and decide if you should keep using it. Blood and urine tests may be needed to check for side effects.

Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you might be pregnant while using the medicine, tell your doctor immediately.

This medicine contains aspirin, which may lead to a condition called Reye's syndrome, especially in children with or recovering from a viral infection (including chicken pox, influenza). Do not give this medicine to these patients unless your doctor has ordered it. Talk to your doctor if you have any concerns.

This medicine may cause confusion, tremors, or lightheadedness, or may make you less alert than usual. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.

Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, rash, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swelling of the face, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be signs of a serious skin reaction called drug with eosinophilia with systemic syndrome (DRESS).

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a drug, the risks of taking the drug must be weighed against the good it will do. This is a decision you and your physician will make. For this medicine, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other drugs. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Since of aspirin's toxicity, use in children younger than 12 years of age is not recommended. Do not give aspirin to a child who has chickenpox or flu symptoms, unless approved by a clinician.

Geriatric

No details is available on the relationship of age to the effects of orphenadrine, aspirin, and caffeine combination in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this drug during breastfeeding. Weigh the potential benefits against the potential chances before using this medication while breastfeeding.

Interactions with Medications

Although certain medicines should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using this medicine, it is especially essential that your healthcare professional know if you are taking any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following drugs is not advised. Your clinician may decide not to treat you with this medicine or change some of the other medicines you take.

• Abrocitinib
• Defibrotide
• Dichlorphenamide
• Influenza Virus Vaccine, Live
• Ketorolac
• Potassium Citrate
• Riociguat
• Viloxazine

Using this drug with any of the following medicines is usually not recommended, but may be required in some cases. If both drugs are prescribed together, your doctor may change the dose or how often you use one or both of the drugs.

• Acarbose
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Acetazolamide
• Alclometasone
• Aldosterone
• Alfentanil
• Alipogene Tiparvovec
• Alprazolam
• Alteplase, Recombinant
• Amantadine
• Amcinonide
• Amifampridine
• Amikacin
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphotericin B
• Amtolmetin Guacil
• Anagrelide
• Anisindione
• Apixaban
• Ardeparin
• Argatroban
• Bacitracin
• Beclomethasone
• Bemetizide
• Bemiparin
• Benazepril
• Bendroflumethiazide
• Benzhydrocodone
• Benzthiazide
• Betamethasone
• Betrixaban
• Bivalirudin
• Brinzolamide
• Bromazepam
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Buprenorphine
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Caplacizumab-yhdp
• Capmatinib
• Capreomycin
• Captopril
• Celecoxib
• Certoparin
• Cetirizine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Choline Salicylate
• Ciclesonide
• Cilostazol
• Cisplatin
• Citalopram
• Clobazam
• Clobetasol
• Clobetasone
• Clocortolone
• Clomipramine
• Clonazepam
• Clonixin
• Clopamide
• Clopidogrel
• Clozapine
• Codeine
• Cortisone
• Curcumin
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Daridorexant
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desonide
• Desoximetasone
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidine
• Diazoxide
• Dibenzepin
• Diclofenac
• Dicumarol
• Diflorasone
• Diflucortolone
• Diflunisal
• Difluprednate
• Digoxin
• Dihydrocodeine
• Dipyrone
• Donepezil
• Dorzolamide
• Dothiepin
• Doxepin
• Doxylamine
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enalapril
• Enalaprilat
• Enoxaparin
• Eplerenone
• Eptifibatide
• Escitalopram
• Esketamine
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Feverfew
• Flibanserin
• Floctafenine
• Flucloronide
• Fludrocortisone
• Flufenamic Acid
• Flumethasone
• Flunisolide
• Fluocinolone
• Fluocinonide
• Fluocortin
• Fluocortolone
• Fluorometholone
• Fluoxetine
• Flurandrenolide
• Flurbiprofen
• Fluticasone
• Fluvoxamine
• Fondaparinux
• Foscarnet
• Fosinopril
• Fosphenytoin
• Furosemide
• Gabapentin
• Gabapentin Enacarbil
• Gentamicin
• Ginkgo
• Givosiran
• Glimepiride
• Glipizide
• Glucagon
• Glyburide
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gossypol
• Halcinonide
• Halobetasol
• Heparin
• Hydrochlorothiazide
• Hydrocodone
• Hydrocortisone
• Hydroflumethiazide
• Hydromorphone
• Ibrutinib
• Ibuprofen
• Imipramine
• Indapamide
• Indomethacin
• Inotersen
• Iobenguane I 131
• Kanamycin
• Ketamine
• Ketoprofen
• Lacosamide
• Lemborexant
• Lepirudin
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Lisinopril
• Lithium
• Lofepramine
• Lofexidine
• Lornoxicam
• Loteprednol
• Loxapine
• Loxoprofen
• Lumiracoxib
• Macimorelin
• Magnesium Oxybate
• Meclofenamate
• Medrysone
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Meperidine
• Metformin
• Methacholine
• Methadone
• Methazolamide
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metoclopramide
• Metolazone
• Midazolam
• Milnacipran
• Moexipril
• Mometasone
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nadroparin
• Nalbuphine
• Naproxen
• Nateglinide
• Nefazodone
• Neomycin
• Nepafenac
• Netilmicin
• Nicorandil
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olanzapine
• Opipramol
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paromomycin
• Paroxetine
• Peginterferon Alfa-2b
• Pemetrexed
• Pentazocine
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Perindopril
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piracetam
• Piretanide
• Piroxicam
• Pixantrone
• Plazomicin
• Polythiazide
• Potassium Citrate
• Potassium Oxybate
• Pranoprofen
• Prasugrel
• Prednicarbate
• Prednisolone
• Prednisone
• Pregabalin
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quetiapine
• Quinapril
• Quinethazone
• Ramipril
• Remifentanil
• Remimazolam
• Repaglinide
• Reteplase, Recombinant
• Revefenacin
• Reviparin
• Rimexolone
• Ritlecitinib
• Rivaroxaban
• Rofecoxib
• Ropeginterferon Alfa-2b-njft
• Salicylic Acid
• Salsalate
• Scopolamine
• Secretin Human
• Selumetinib
• Sertraline
• Sodium Oxybate
• Sodium Salicylate
• Spectinomycin
• Spirapril
• Spironolactone
• Streptomycin
• Sufentanil
• Sulindac
• Sulodexide
• Tacrolimus
• Tapentadol
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tiotropium
• Tirofiban
• Tobramycin
• Tocilizumab
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Torsemide
• Tramadol
• Trandolapril
• Trazodone
• Treprostinil
• Triamcinolone
• Triamterene
• Trichlormethiazide
• Trimipramine
• Turmeric
• Valdecoxib
• Valproic Acid
• Vancomycin
• Varicella Virus Vaccine, Live
• Venlafaxine
• Vilazodone
• Vortioxetine
• Warfarin
• Xipamide
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both drugs are prescribed together, your clinician may change the dose or how often you use one or both of the drugs.

• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Delapril
• Esmolol
• Imidapril
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nitroglycerin
• Oxprenolol
• Penbutolol
• Perphenazine
• Pindolol
• Probenecid
• Propranolol
• Sotalol
• Streptokinase
• Tamarind
• Temocapril
• Tenecteplase
• Timolol

Interactions with Food/Tobacco/Alcohol

Certain medications should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medications may additionally cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is normally not advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Using this medication with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical issues may affect the use of this drug. Make sure you inform your doctor if you have any other medical problems, especially:

• Bladder problem or
• Enlarged prostate or
• Esophagus problem (eg, achalasia) or
• Glaucoma or
• Myasthenia gravis or
• Stomach or bowel blockage (eg, pyloric or duodenal obstruction)—Should not be used in patients with these conditions.

• Blood clotting problem or
• Stomach ulcer—Use with caution. May raise risk for more adverse effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Agitation
• anxiety
• confusion
• fast or irregular breathing
• irritability
• nervousness
• nightmares
• restlessness
• seeing, hearing, or feeling things that are not there
• seizures
• tremors
• unusual feeling of excitement

Rare

• Black, tarry stools
• chest pain or tightness
• chills
• cough
• fever
• headache
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen or painful glands
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds

Incidence not known

• Decrease in the frequency of urination or urine volume
• difficulty in passing urine (dribbling)
• dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• lightheadedness
• painful urination

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Blurred vision
• constipation
• drowsiness
• dry mouth
• itching, red, skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Norgesic
• Norgesic Forte
• Orphenadrine w/A.C.
• Orphengesic
• Orphengesic Forte

Available Dosage Forms:

• Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination

Pharmacologic Class: Orphenadrine

Chemical Class: Salicylate, Aspirin

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets): For mild to moderate muscle or bone pain: Adults and children older than 12 years of age—One-half or one tablet 3 or 4 times a day. Each tablet contains 50 milligrams (mg) orphenadrine, 770 mg aspirin, and 60 mg caffeine. Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.