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Codeine-Butalbital-ASA-Caff

Warning

Codeine has a risk for abuse and addiction, which can lead to overdose and death. Codeine may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of codeine that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.

Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of codeine from your body, which may affect how codeine works. Be sure you know how to take this medication and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this medication, get medical help right away.

Children younger than 18 years should not use products that contain codeine. Some children are more sensitive to codeine and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section). The risk is greater in children who are obese or have breathing problems, or after certain surgeries (including tonsil/adenoid removal). Talk with your doctor or pharmacist about the risks and benefits of this medication.

Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to aspirin, caffeine, codeine, or butalbital; or to other barbiturates (such as phenobarbital), salicylates (such as salsalate), nonsteroidal anti-inflammatory drugs (such as ibuprofen), opioid pain medications (such as morphine) or xanthine derivatives (such as theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), bleeding/blood clotting disorders (such as hemophilia, von Willebrand's disease, thrombocytopenia), a certain enzyme disorder (porphyria), disease of the pancreas (such as pancreatitis), heart disease (such as irregular heartbeat, recent heart attack), certain enzyme deficiencies (pyruvate kinase or G6-PD deficiency), gout, liver disease, kidney disease, heartburn, growths in the nose (nasal polyps), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood disorders, stomach/intestinal problems (such as stomach/intestinal ulcers, infectious diarrhea, colitis), adrenal gland problem (such as Addison's disease), difficulty urinating (such as due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), recent bowel/abdominal surgery, obesity.

Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication contains aspirin. Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye's syndrome, a rare but serious illness.

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, stomach/intestinal bleeding and ulcers, and trouble falling asleep. Confusion, dizziness, drowsiness and trouble falling asleep can increase the risk of falling.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Nausea, vomiting, stomach upset, gas, shaking (tremor), constipation, dry mouth, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: interrupted breathing during sleep (sleep apnea), mental/mood changes, fast/irregular heartbeat, increased thirst/urination, hearing changes (such as ringing in the ears), easy bruising/bleeding, heartburn, discomfort when swallowing, dark urine, yellowing eyes/skin, signs of kidney problems (such as change in the amount of urine), signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).

Get medical help right away if you have any very serious side effects, including: fainting, seizure, black stools, severe stomach/abdominal pain, vomit that looks like coffee grounds, trouble speaking, weakness on one side of the body.

Codeine is changed into a strong opioid drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, severe drowsiness/difficulty waking up, confusion.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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