Oxycodone Hydrochloride, Acetaminophen Oral capsule

What is this medicine?

ACETAMINOPHEN; OXYCODONE (a set a MEE noe fen; ox i KOE done) 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:

• brain tumor

• Crohn's disease, inflammatory bowel disease, or ulcerative colitis

• drug abuse or addiction

• head injury

• heart or circulation problems

• if you often drink alcohol

• kidney disease or problems going to the bathroom

• liver disease

• lung disease, asthma, or breathing problems

• an unusual or allergic reaction to salicylates, acetaminophen, oxycodone, other opioid analgesics, 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 full glass of water. Follow the directions on the prescription label. If the medicine upsets your stomach, take it with food or milk. Take your medicine at regular intervals. Do not take your medicine more often than directed.

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?

• alcohol

• antihistamines

• barbiturates like amobarbital, butalbital, butabarbital, methohexital, pentobarbital, phenobarbital, thiopental, and secobarbital

• benztropine

• drugs for bladder problems like solifenacin, trospium, oxybutynin, tolterodine, hyoscyamine, and methscopolamine

• drugs for breathing problems like ipratropium and tiotropium

• drugs for certain stomach or intestine problems like propantheline, homatropine methylbromide, glycopyrrolate, atropine, belladonna, and dicyclomine

• general anesthetics like etomidate, ketamine, nitrous oxide, propofol, desflurane, enflurane, halothane, isoflurane, and sevoflurane

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• muscle relaxants

• naltrexone

• narcotic medicines (opiates) for pain

• phenothiazines like perphenazine, thioridazine, chlorpromazine, mesoridazine, fluphenazine, prochlorperazine, promazine, and trifluoperazine

• scopolamine

• tramadol

• trihexyphenidyl

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 medication for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.

Do not suddenly stop taking your medicine 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 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.

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.

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.

Do not take Tylenol (acetaminophen) or medicines that have acetaminophen with this medicine. Too much acetaminophen can be very dangerous. Many non-prescription medicines contain acetaminophen. Always read the labels carefully to avoid taking more acetaminophen.

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 difficulties, wheezing

• confusion

• light headedness or fainting spells

• severe stomach pain

• unusually weak or tired

• yellowing of the skin or the whites of the eyes

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

• dizziness

• drowsiness

• nausea

• vomiting

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 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Protect from light.

This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. Flush any unused medicine down the toilet to reduce the chance of harm. Do not use the 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.

Oxycodone Hydrochloride, Acetaminophen Oral solution

What is this medicine?

ACETAMINOPHEN; OXYCODONE (a set a MEE noe fen; ox i KOE done) 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:

• brain tumor

• Crohn's disease, inflammatory bowel disease, or ulcerative colitis

• drug abuse or addiction

• head injury

• heart or circulation problems

• if you often drink alcohol

• kidney disease or problems going to the bathroom

• liver diseaselung disease, asthma, or breathing problems

• an unusual or allergic reaction to acetaminophen, oxycodone, other opioid analgesics, 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 full glass of water. Use a specially marked spoon or dropper to measure your dose. Ask your pharmacist if you do not have one. Do not use a household spoon. Follow the directions on the prescription label. If the medicine upsets your stomach, take the medicine with food or milk.

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?

• alcohol

• antihistamines

• barbiturates like amobarbital, butalbital, butabarbital, methohexital, pentobarbital, phenobarbital, thiopental, and secobarbital

• benztropine

• drugs for bladder problems like solifenacin, trospium, oxybutynin, tolterodine, hyoscyamine, and methscopolamine

• drugs for breathing problems like ipratropium and tiotropium

• drugs for certain stomach or intestine problems like propantheline, homatropine methylbromide, glycopyrrolate, atropine, belladonna, and dicyclomine

• general anesthetics like etomidate, ketamine, nitrous oxide, propofol, desflurane, enflurane, halothane, isoflurane, and sevoflurane

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• muscle relaxants

• naltrexone

• narcotic medicines (opiates) for pain

• phenothiazines like perphenazine, thioridazine, chlorpromazine, mesoridazine, fluphenazine, prochlorperazine, promazine, and trifluoperazine

• scopolamine

• tramadol

• trihexyphenidyl

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 medication for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.

Do not suddenly stop taking your medicine 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 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.

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.

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.

Do not take Tylenol (acetaminophen) or medicines that have acetaminophen with this medicine. Too much acetaminophen can be very dangerous. Many non-prescription medicines contain acetaminophen. Always read the labels carefully to avoid taking more acetaminophen.

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 difficulties, wheezing

• confusion

• light headedness or fainting spells

• severe stomach pain

• unusually weak or tired

• yellowing of the skin or the whites of the eyes

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

• dizziness

• drowsiness

• nausea

• vomiting

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 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed.

This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. Flush any unused medicine down the toilet to reduce the chance of harm. Do not use the 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.

Oxycodone Hydrochloride, Acetaminophen Oral tablet

What is this medicine?

ACETAMINOPHEN; OXYCODONE (a set a MEE noe fen; ox i KOE done) 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:

• brain tumor

• Crohn's disease, inflammatory bowel disease, or ulcerative colitis

• drug abuse or addiction

• head injury

• heart or circulation problems

• if you often drink alcohol

• kidney disease or problems going to the bathroom

• liver disease

• lung disease, asthma, or breathing problems

• an unusual or allergic reaction to acetaminophen, oxycodone, other opioid analgesics, 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 full glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed.

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?

• alcohol

• antihistamines

• barbiturates like amobarbital, butalbital, butabarbital, methohexital, pentobarbital, phenobarbital, thiopental, and secobarbital

• benztropine

• drugs for bladder problems like solifenacin, trospium, oxybutynin, tolterodine, hyoscyamine, and methscopolamine

• drugs for breathing problems like ipratropium and tiotropium

• drugs for certain stomach or intestine problems like propantheline, homatropine methylbromide, glycopyrrolate, atropine, belladonna, and dicyclomine

• general anesthetics like etomidate, ketamine, nitrous oxide, propofol, desflurane, enflurane, halothane, isoflurane, and sevoflurane

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• muscle relaxants

• naltrexone

• narcotic medicines (opiates) for pain

• phenothiazines like perphenazine, thioridazine, chlorpromazine, mesoridazine, fluphenazine, prochlorperazine, promazine, and trifluoperazine

• scopolamine

• tramadol

• trihexyphenidyl

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 medication for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.

Do not suddenly stop taking your medicine 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.

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.

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.

Do not take Tylenol (acetaminophen) or medicines that have acetaminophen with this medicine. Too much acetaminophen can be very dangerous. Many nonprescription medicines contain acetaminophen. Always read the labels carefully to avoid taking more acetaminophen.

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 difficulties, wheezing

• confusion

• light headedness or fainting spells

• severe stomach pain

• unusually weak or tired

• yellowing of the skin or the whites of the eyes

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

• dizziness

• drowsiness

• nausea

• vomiting

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). Keep container tightly closed. Protect from light.

This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. Flush any unused medicine down the toilet to reduce the chance of harm. Do not use the 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.

Oxycodone Hydrochloride, Acetaminophen Oral tablet, biphasic release

What is this medicine?

ACETAMINOPHEN; OXYCODONE (a set a MEE noe fen; ox i KOE done) 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:

• brain tumor

• Crohn's disease, inflammatory bowel disease, or ulcerative colitis

• drink more than 3 alcohol containing drinks per day

• drug abuse or addiction

• head injury

• heart or circulation problems

• kidney disease or problems going to the bathroom

• liver disease

• lung disease, asthma, or breathing problems

• an unusual or allergic reaction to acetaminophen, oxycodone, other opioid analgesics, 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 full glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

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?

• alcohol

• antihistamines

• barbiturates like amobarbital, butalbital, butabarbital, methohexital, pentobarbital, phenobarbital, thiopental, and secobarbital

• benztropine

• drugs for bladder problems like solifenacin, trospium, oxybutynin, tolterodine, hyoscyamine, and methscopolamine

• drugs for breathing problems like ipratropium and tiotropium

• drugs for certain stomach or intestine problems like propantheline, homatropine methylbromide, glycopyrrolate, atropine, belladonna, and dicyclomine

• general anesthetics like etomidate, ketamine, nitrous oxide, propofol, desflurane, enflurane, halothane, isoflurane, and sevoflurane

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• muscle relaxants

• naltrexone

• narcotic medicines (opiates) for pain

• phenothiazines like perphenazine, thioridazine, chlorpromazine, mesoridazine, fluphenazine, prochlorperazine, promazine, and trifluoperazine

• scopolamine

• tramadol

• trihexyphenidyl

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 medication for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.

Do not suddenly stop taking your medicine 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.

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.

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.

Do not take other medicines that contain acetaminophen with this medicine. Always read labels carefully. If you have questions, ask your doctor or pharmacist.

If you take too much acetaminophen get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

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 difficulties, wheezing

• confusion

• dark urine

• general ill feeling or flu-like symptoms

• light colored stools

• light headedness or fainting spells

• right upper belly pain

• unusually weak or tired

• yellowing of the skin or the whites of the eyes

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

• dizziness

• drowsiness

• nausea

• vomiting

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 15 and 30 degrees C (59 and 86 degrees F).

This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. Flush any unused medicine down the toilet to reduce the chance of harm. Do not use the 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.