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|Acetaminophen/Codeine Suspension

Acetaminophen/Codeine Suspension

Acetaminophen/Codeine Suspension is used for:

Relieving mild to moderate pain. It may also be used for other conditions as determined by your doctor.

Acetaminophen/Codeine Suspension is an analgesic combination. It works in certain areas of the brain and nervous system to decrease pain. The combination may provide better pain relief than either medicine alone.

Do NOT use Acetaminophen/Codeine Suspension if:

• you are allergic to any ingredient in Acetaminophen/Codeine Suspension or any other codeine- or morphine-related medicine (eg, oxycodone)
• you have severe diarrhea due to taking an antibiotic
• you are taking naltrexone, quinidine, or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen/Codeine Suspension:

Some medical conditions may interact with Acetaminophen/Codeine Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of alcoholism or substance abuse, or you consume more than 3 alcoholic drinks per day
• if you have considered or attempted suicide
• if you have recently had any head injury, brain injury or tumor, increased pressure in the brain, or an infection of the brain or nervous system
• if you have asthma, other lung or breathing problems, epilepsy, or seizures
• if you have a history of stomach or intestinal problems, chronic inflammation or ulceration of the bowel, or gallbladder problems (eg, gallstones), or you have had recent abdominal surgery
• if you have Addison disease, heart problems, liver problems (eg, hepatitis), an underactive thyroid, prostate problems, severe kidney problems, or urinary problems

Some MEDICINES MAY INTERACT with Acetaminophen/Codeine Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Naltrexone because it may decrease the effectiveness of Acetaminophen/Codeine Suspension and withdrawal symptoms may occur if you are physically dependent on opioids. You must not take naltrexone until you have stopped taking Acetaminophen/Codeine Suspension for 7 to 10 days and after a naloxone challenge test is negative.
• Quinidine because it may decrease the effectiveness of this medicine
• Cimetidine, ethanol, HIV protease inhibitors (eg, ritonavir), isoniazid, medicine for mental or mood disorders (eg, olanzapine, haloperidol), medicine for anxiety (eg, diazepam), other narcotic pain medicine (eg, oxycodone), or sodium oxybate (GHB) because side effects such as excessive drowsiness, disorientation, trouble breathing, or seizures may occur
• Anticoagulants (eg, warfarin) because the risk of side effects such as bleeding may be increased by Acetaminophen/Codeine Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Codeine Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Codeine Suspension:

Use Acetaminophen/Codeine Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Acetaminophen/Codeine Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Acetaminophen/Codeine Suspension and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Codeine Suspension.

Important safety information:

• Acetaminophen/Codeine Suspension may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Codeine Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Acetaminophen/Codeine Suspension may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Acetaminophen/Codeine Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Acetaminophen/Codeine Suspension may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Codeine Suspension. Talk to your doctor before you take Acetaminophen/Codeine Suspension or other fever reducers if you drink more than 3 drinks with alcohol per day.
• Do not take more than the recommended dose or use Acetaminophen/Codeine Suspension for longer than prescribed without checking with your doctor. Do not suddenly stop taking Acetaminophen/Codeine Suspension without first checking with your doctor.
• Acetaminophen/Codeine Suspension has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Acetaminophen/Codeine Suspension may cause constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while taking Acetaminophen/Codeine Suspension, talk with your doctor or pharmacist. A stool softener or fiber laxative may be required.
• If nausea occurs, consult your doctor or pharmacist about alternatives for decreasing nausea (eg, taking antihistamines, lying down for 1 to 2 hours with minimal head movement).
• Use Acetaminophen/Codeine Suspension with caution in the ELDERLY; they may be more sensitive to its effect, especially drowsiness and trouble breathing.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen/Codeine Suspension while you are pregnant. Acetaminophen/Codeine Suspension is found in breast milk. If you are or will be breast-feeding while you use Acetaminophen/Codeine Suspension, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Acetaminophen/Codeine Suspension may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Acetaminophen/Codeine Suspension stops working well. Do not take more than prescribed.

Some people who use Acetaminophen/Codeine Suspension for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Acetaminophen/Codeine Suspension, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Acetaminophen/Codeine Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; dizziness; drowsiness; exaggerated sense of well-being; feeling unwell or unhappy; flushing; lightheadedness; mental/mood changes; nausea; stomach pain; vision changes; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine; dark urine; difficulty breathing; slow/irregular breathing; slow/irregular heartbeat; stomach pain; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include cold, clammy skin; extreme drowsiness; fatigue; loss of consciousness; persistent nausea/vomiting; slow heartbeat; slow, shallow, or abnormal breathing; stomach pain; unusual sweating; weakness; yellowing of the skin or eyes.

Store Acetaminophen/Codeine Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Codeine Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Acetaminophen/Codeine Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Acetaminophen/Codeine Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Acetaminophen/Codeine Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.