Acetaminophen, Caffeine, Dihydrocodeine Bitartrate Oral tablet

What is this medicine?

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE (a set a MEE noe fen; 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:

• drink more than 3 alcohol containing drinks per day
• drug abuse or addiction
• head injury
• heart, circulation problems
• kidney disease
• liver disease
• lung or breathing disease
• stomach, intestine problems
• an unusual or allergic reaction to acetaminophen, caffeine, dihydrocodeine, codeine, 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.

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

This medicine may also interact with the following medications:

• barbiturates like phenobarbital
• carbamazepine
• ciprofloxacin
• disulfiram
• isoniazid
• medicines for high blood pressure or other heart problems
• medicines for anxiety, sleep
• medicines for asthma, other breathing problems
• medicines for sleep during surgery
• medicines for pain like buprenorphine, codeine, pentazocine
• muscle relaxants
• other acetaminophen products
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• phenytoin
• some medicines for allergies, colds
• warfarin

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 nonmedical reason. 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.

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.

Many non-prescription medicines contain acetaminophen as an ingredient. Always read the labels carefully to avoid taking an accidental overdose, which can be dangerous.

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
• ringing in the ears
• tremors
• yellowing of the eyes or skin

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
• 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 between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.