Extradol

Each caplet contains acetaminophen 500 mg and Caffeine (Extradol) 65 mg.

This medication contains a combination of acetaminophen, aspirin, and Caffeine (Extradol). Acetaminophen is a pain reliever and a fever reducer. Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation. Caffeine (Extradol) is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

This medication is used to treat pain caused by tension headaches, migraine headaches, muscle aches, menstrual cramps, arthritis, toothaches, the common cold, or nasal congestion.

Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Extradol contains a combination of acetaminophen, aspirin, and Caffeine (Extradol). Acetaminophen is a pain reliever and a fever reducer. Aspirin is in a group of drugs called salicylates. It works by reducing substances in the body that cause pain, fever, and inflammation. Caffeine (Extradol) is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Extradol is used to treat pain caused by tension headaches, migraine headaches, muscle aches, menstrual cramps, arthritis, toothaches, the common cold, or nasal congestion.

Extradol may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Cold Symptoms

12 years of age or older:

Initial dose: Caffeine (Extradol) 130 mg-acetaminophen 1000 mg orally every 6 hours as needed

Maximum dose: Caffeine (Extradol) 520 mg-acetaminophen 4000 mg orally in 24 hours

Use(s): For the temporary relief of the minor pain of headache, sinusitis, colds, muscular aches, menstrual discomfort, toothache, and arthritis pain.

Usual Adult Dose for Dysmenorrhea

12 years of age or older:

Initial dose: Caffeine (Extradol) 130 mg-acetaminophen 1000 mg orally every 6 hours as needed

Maximum dose: Caffeine (Extradol) 520 mg-acetaminophen 4000 mg orally in 24 hours

Use(s): For the temporary relief of the minor pain of headache, sinusitis, colds, muscular aches, menstrual discomfort, toothache, and arthritis pain.

Usual Adult Dose for Osteoarthritis

12 years of age or older:

Initial dose: Caffeine (Extradol) 130 mg-acetaminophen 1000 mg orally every 6 hours as needed

Maximum dose: Caffeine (Extradol) 520 mg-acetaminophen 4000 mg orally in 24 hours

Use(s): For the temporary relief of the minor pain of headache, sinusitis, colds, muscular aches, menstrual discomfort, toothache, and arthritis pain.

Usual Adult Dose for Pain

12 years of age or older:

Initial dose: Caffeine (Extradol) 130 mg-acetaminophen 1000 mg orally every 6 hours as needed

Maximum dose: Caffeine (Extradol) 520 mg-acetaminophen 4000 mg orally in 24 hours

Use(s): For the temporary relief of the minor pain of headache, sinusitis, colds, muscular aches, menstrual discomfort, toothache, and arthritis pain.

Usual Adult Dose for Sinusitis

12 years of age or older:

Initial dose: Caffeine (Extradol) 130 mg-acetaminophen 1000 mg orally every 6 hours as needed

Maximum dose: Caffeine (Extradol) 520 mg-acetaminophen 4000 mg orally in 24 hours

Use(s): For the temporary relief of the minor pain of headache, sinusitis, colds, muscular aches, menstrual discomfort, toothache, and arthritis pain.

Usual Adult Dose for Headache

12 years of age or older:

Initial dose: Caffeine (Extradol) 130 mg-acetaminophen 1000 mg orally every 6 hours as needed

Maximum dose: Caffeine (Extradol) 520 mg-acetaminophen 4000 mg orally in 24 hours

Use(s): For the temporary relief of the minor pain of headache, sinusitis, colds, muscular aches, menstrual discomfort, toothache, and arthritis pain.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Use with caution in patients with liver disease. Chronic use of acetaminophen is not recommended in patients with liver disease.

Precautions

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

General:

-The recommended dose contains about as much Caffeine (Extradol) as a cup of coffee. Caffeine (Extradol) containing medications, foods, or beverages should be limited while taking this product because too much Caffeine (Extradol) may cause nervousness, irritability, sleeplessness, and rapid heartbeat.

-Caffeine (Extradol) is a central nervous system stimulant and in cases of Caffeine (Extradol) overdose, seizures have been reported.

Patient advice:

-Patients who consume three or more alcohol containing drinks per day should be informed to consult with their physician for advice on when and how to take acetaminophen. Chronic, heavy alcohol users may be at increased risk of liver damage when taking more than recommended dosages.

-A healthcare provider should be contacted if pain gets worse or lasts more than 10 days, a fever lasts more than 3 days, new symptoms occur, redness or swelling are present, or symptoms do not get better.

-Acetaminophen can cause liver damage. Patients should not take more than 4000 mg in 24 hours, should not take other products containing acetaminophen, or drink more than 3 alcoholic drinks daily while taking this product.

-Patients should be advised to consult with their doctor before continuing to use acetaminophen if symptoms of illness worsen. Although rare, there is the possibility of acetaminophen intoxication on chronic use of the drug, and the symptoms seen during the first phase of intoxication (nausea, vomiting, anorexia, malaise, and diaphoresis) may trigger the use of more doses.

See also:
What is the most important information I should know about Extradol?

This medicaion should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin in this medicine can cause a serious and sometimes fatal condition called Reye’s syndrome in children. You should not use this if you are allergic to acetaminophen (Tylenol), aspirin, or Caffeine (Extradol), or if you have:

a recent history of stomach or intestinal bleeding;

liver disease;

asthma or severe allergic reaction caused by taking aspirin or a non-steroidal anti-inflammatory drug (NSAID), especially "aspirin triad syndrome"; or

if you are allergic to an NSAID such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

asthma or seasonal allergies;

fever with a stiff neck;

a stomach ulcer, heartburn, or stomach pain;

a bleeding or blood clotting disorder such as hemophilia;

diabetes; or

gout.

Use Extradol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Extradol may be taken with or without food.
• If you miss a dose of Extradol and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Extradol.

See also:
What other drugs will affect Extradol?

Avoid drinking alcohol while you are taking this medication. Alcohol may increase your risk of stomach bleeding while taking aspirin, or liver damage while taking acetaminophen. Do not use any other cough, cold, allergy, pain, menstrual symptom, or fever medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP", aspirin, and Caffeine (Extradol) are contained in many combination medicines. If you use certain products together you may accidentally use too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, aspirin, or Caffeine (Extradol).

Avoid taking an NSAID such as ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid coffee, tea, cola, energy drinks or other sources of Caffeine (Extradol) while taking this medication. They can add to the side effects of the Caffeine (Extradol) in this medication.

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.

Before taking it, tell your doctor if you are using any of the following drugs:

a blood thinner such as warfarin (Coumadin);

salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan’s Pills Extra Strength, Tricosal, and others; or

medication used to prevent blood clots, such as alteplase (Activase), clopidogrel (Plavix), dipyridamole (Persantine), ticlopidine (Ticlid), and urokinase (Abbokinase).

This list is not complete and there may be other drugs that can interact with the medicine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

See also:
What are the possible side effects of Extradol?

Get emergency medical help if you have any of these signs of an allergic reaction to Extradol: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

weakness or fainting;

black, bloody, or tarry stools;

coughing up blood or vomit that looks like coffee grounds;

severe nausea, vomiting, or stomach pain;

redness or swelling;

low fever with nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever lasting longer than 3 days;

pain lasting longer than 10 days; or

hearing problems, ringing in your ears.

Less serious side effects may include:

upset stomach, heartburn;

feeling nervous or excited; or

sleep problems (insomnia).