Aspirin, Caffeine, Dihydrocodeine Bitartrate Oral capsule

What is this medicine?

ASPIRIN; CAFFEINE; DIHYDROCODEINE (AS pir in; KAF een; dye hye droe KOE deen) is a pain reliever. It is used to treat moderate to severe pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood clotting problems

• drug abuse or addiction

• head injury

• heart, circulation problems

• kidney disease

• liver disease

• lung or breathing disease

• stomach ulcer, intestine problems

• an unusual or allergic reaction to aspirin, caffeine, dihydrocodeine, codeine, or other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. Do not use this medicine in children 12 years old or younger.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alcohol

• cidofovir

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• medicines for gout like probenecid, sulfinpyrazone

• medicines that treat or prevent blood clots like enoxaparin, warfarin

• methotrexate

• other aspirin products

• procarbazine

This medicine may also interact with the following medications:

• antihistamines for allergy, cough and cold

• barbiturate medicines for seizures, sleep

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for sleep

• ginkgo biloba

• medicines for asthma, other breathing problems

• medicines for high blood pressure or other heart problems

• medicines for sleep during surgery

• muscle relaxants

• narcotic medicines (opiates) for pain

• tramadol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking it because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Children may be at higher risk for side effects. If your child has slow breathing, noisy breathing, confusion, or unusual sleepiness, stop giving this medicine and get medical help right away.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

Too much aspirin can be very dangerous. Do not take aspirin or medicines that contain aspirin with this medicine. Many non-prescription medicines contain aspirin. Always read the labels carefully.

The medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in behavior, mood

• confusion

• fast or slow heartbeat

• feeling faint or lightheaded

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• ringing in the ears

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• tremors

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• dry mouth

• nausea, vomiting

• passing urine more often

• stomach upset

• trouble sleeping

• unusual sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature at 25 degrees C (77 degrees F). Keep container tightly closed.

Throw away any unused medicine after the expiration date. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.