No information provided.

Last updated on RxList: 4/7/2009

1. Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.
2. The orphenadrine component 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 orphenadrine has not been clearly identified, but may be related to its analgesic properties. Norgesic and Norgesic Forte do not directly relax tense skeletal muscles in man.

Norgesic: Adults 1 to 2 tablets 3 to 4 times daily.

Norgesic Forte: Adults ½ to 1 tablet 3 to 4 times daily.

Norgesic tablets can be identified by their two layers colored white and yellow. Each round tablet is embossed “NORGESIC” on one side and “3M” on the other and contains orphenadrine citrate (2-dimethylaminoethyl 2-methylbenzhydryl ether citrate) 25 mg, aspirin 385 mg, and caffeine 30 mg.

Norgesic Forte tablets are exactly twice the strength of Norgesic. They are identified by their scored capsule shape and by their two layers colored white and yellow. Each capsule shaped tablet is embossed “NORGESIC FORTE” on one side and “3M” on the other and contains orphenadrine citrate 50 mg, aspirin 770 mg, and caffeine 60 mg.

Norgesic and Norgesic Forte also contain: lactose, polyethylene glycol, povidone, starch, sucrose, zinc stearate, and D&C yellow #10.

Norgesic: Bottles of 100 tablets (NDC 0089-0231-10) and 500 tablets (NDC 0089-0231-50).

Norgesic Forte: Bottles of 100 tablets (NDC 0089-0233-10) and 500 tablets (NDC 0089-0233-50).

Store below 30°C (86°F).

MAY 1998. 3M Pharmaceuticals, Northridge, CA 91324.

Last updated on RxList: 4/7/2009

Side effects of Norgesic or Norgesic Forte are those seen with aspirin and caffeine or those usually associated with mild anticholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilatation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of confusion. Mild central excitation and occasional hallucinations may be observed. These mild side effects can usually be eliminated by reduction in dosage. One case of aplastic anemia associated with the use of Norgesic has been reported. No causal relationship has been established. Rare G.I. hemorrhage due to aspirin content may be associated with the administration of Norgesic or Norgesic Forte. Some patients may experience transient episodes of light-headedness, dizziness or syncope.

No information provided.

Last updated on RxList: 4/7/2009

Reye's Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest a possible association between the development of Reye's Syndrome and the use of medicines containing salicylate or aspirin. Norgesic and Norgesic Forte contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms. Norgesic and Norgesic Forte may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation abnormalities.

Usage In Pregnancy

Since safety of the use of this preparation in pregnancy, during lactation, or in the childbearing age has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against its possible hazard to the mother and child.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Confusion, anxiety and tremors have been reported in a few patients receiving propoxyphene and orphenadrine concomitantly. As these symptoms may be simply due to an additive effect, reduction of dosage and/or discontinuation of one or both agents is recommended in such cases.

Safety of continuous long term therapy with Norgesic and Norgesic Forte has not been established; therefore, if Norgesic or Norgesic Forte is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

Last updated on RxList: 4/7/2009

No information provided.

Because of the mild anticholinergic effect of orphenadrine, Norgesic or Norgesic Forte should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. Norgesic or Norgesic Forte is also contraindicated in patients with myasthenia gravis and in patients known to be sensitive to aspirin or caffeine.

The drug is contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

Last updated on RxList: 4/7/2009

Actions

Orphenadrine citrate is a centrally acting (brain stem) compound which in animals selectively blocks facilitatory functions of the reticular formation. Orphenadrine does not produce myoneural block, nor does it affect crossed extensor reflexes. Orphenadrine prevents nicotine-induced convulsions but not those produced by strychnine.

Chronic administration of Norgesic to dogs and rats has revealed no drug-related toxicity. No blood or urine changes were observed, nor were there any macroscopic or microscopic pathological changes detected. Extensive experience with combinations containing aspirin and caffeine has established them as safe agents. The addition of orphenadrine citrate does not alter the toxicity of aspirin and caffeine.

The mode of therapeutic action of orphenadrine has not been clearly identified, but may be related to its analgesic properties.

Orphenadrine citrate also possesses anticholinergic actions.

Last updated on RxList: 4/7/2009

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 4/7/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

ORPHENADRINE/ASPIRIN/CAFFEINE - ORAL

(or-FEN-uh-dreen/ASP-er-in/KAF-een)

COMMON BRAND NAME(S): Norgesic

USES: This medication is a combination of orphenadrine, aspirin, and caffeine. It provides temporary relief of pain and discomfort from muscle injuries such as strains, sprains, and spasms. It is usually used along with rest, physical therapy, and other treatments (e.g., nonsteroidal anti-inflammatory medication).

Orphenadrine relaxes tight muscles and relieves pain, cramping, and stiffness so you can move around more and get back to doing your daily activities. Orphenadrine belongs to a class of drugs called muscle relaxants. Aspirin helps decrease pain and swelling. Caffeine may help increase the effects of aspirin on pain.

HOW TO USE: Take this medication by mouth, usually 3-4 times a day or as directed by your doctor. Take with food or milk if stomach upset occurs.

Take this medication with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this drug.

The dosage is based on your medical condition and response to therapy. Take this medication exactly as prescribed. Do not increase your dose, take it more often, or take it for longer than prescribed. Your condition will not improve any faster, but the risk of side effects may be increased.

Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Dizziness, drowsiness, blurred vision, weakness, headache, stomach upset, heartburn, nausea, constipation, and dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

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: mental/mood changes (e.g., confusion, anxiety, hallucinations), fast/pounding heartbeat, hearing changes (e.g., ringing in the ears), difficult urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, black/bloody/tarry stools, fainting, fast heartbeat, eye pain, stomach/intestinal blockage (e.g., persistent nausea/vomiting, prolonged constipation), difficult/painful swallowing, unusual tiredness, change in the amount of urine, 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, severe dizziness, breathing trouble.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to orphenadrine, aspirin, or caffeine or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain eye problem (glaucoma), aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), stomach/intestinal ulcers or blockage, enlarged prostate, bladder blockage, a certain esophagus problem (mega-esophagus/cardio-spasm), a certain type of muscle disease (myasthenia gravis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, growths in the nose (nasal polyps), bleeding problems, gout, stomach problems (e.g., acid-reflux disease, heartburn), heart problems (e.g., fast heartbeat, irregular heartbeat, heart failure), high blood pressure, kidney disease, liver disease, urinary problems (e.g., trouble starting the flow of urine).

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit alcoholic beverages.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

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 without first consulting a doctor about Reye's syndrome, a rare but serious illness.

The elderly may be more sensitive to the side effects of this drug, especially confusion.

Aspirin is not recommended for use during pregnancy. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Aspirin passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: mifepristone, flu vaccine inhaled through the nose, pramlintide.

If you are currently using any of the medications listed above, tell your doctor or pharmacist before using this product.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: ACE inhibitors (e.g., lisinopril, enalapril), acetazolamide, anticholinergic drugs (e.g., atropine, belladonna alkaloids, scopolamine), blood thinners (e.g., warfarin, enoxaparin), certain anti-Parkinson's drugs (e.g., benztropine, trihexyphenidyl), bisphosphonate drugs (e.g., alendronate, etidronate, risedronate), cimetidine, certain drugs to treat gout (e.g., uricosurics such as probenecid, sulfinpyrazone), corticosteroids (e.g., prednisone), diabetes drugs (e.g., sulfonylureas such as glyburide), ginkgo biloba, lithium, methotrexate, pemetrexed, potassium tablets/capsules, propoxyphene.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, pain/fever reducers) because they may contain aspirin, caffeine, or ingredients that cause drowsiness. Also remember that certain beverages (e.g., coffee, colas, tea) contain caffeine. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local 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: unusual excitement, fast/irregular heartbeat, 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 told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: 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 and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store below 86 degrees F (30 degrees C) away from heat and light. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised August 2008 Copyright(c) 2008 First DataBank, Inc.