Codeine is in a group of drugs called narcotic pain relievers.

Acetaminophen is a less potent pain reliever that increases the effects of codeine.

The combination of acetaminophen and codeine is used to relieve moderate to severe pain.

Acetaminophen and codeine may also be used for purposes other than those listed in this medication guide.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One acetaminophen and codeine tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

If your medicine contains 650 mg of acetaminophen per tablet, take no more than 6 tablets in 24 hours. If your medicine contains 500 mg or less of acetaminophen, take no more than 8 tablets in 24 hours. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take this medicine with a full glass of water.

You may take the medication with food or milk if it causes stomach upset.

Measure the liquid form of this medication with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and codeine. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using acetaminophen and codeine. You may need to stop using the medicine for a short time.

Store acetaminophen and codeine at room temperature away from moisture and heat.

Before taking this medication, tell your doctor if you are using any of the following drugs:

• atropine (Donnatal, and others), benztropine (Cogentin), methscopolamine (Pamine) or scopolamine (Transderm-Scop);

• glycopyrrolate (Robinul);

• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva); or

• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

If you are using any of these drugs, you may not be able to use acetaminophen and codeine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect acetaminophen and codeine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen is contained in many cold and pain medicines available over the counter. If you take certain products together you may accidentally take too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen.

Do not drink alcohol while you are taking acetaminophen and codeine. Dangerous side effects or death can occur when alcohol is combined with codeine.

Do not take acetaminophen and codeine with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of acetaminophen and codeine can be fatal.

Symptoms of an acetaminophen and codeine coverdose may include extreme drowsiness, sweating, nausea, vomiting, low fever, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), confusion, cold and clammy skin, shallow breathing, slow heart rate, fainting, or coma.

Since acetaminophen and codeine is sometimes used as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Do not take acetaminophen and codeine with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Codeine may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and codeine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Keep track of how many tablets have been used from each new bottle of this medicine. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Never take more acetaminophen and codeine than is prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not use this medication if you are allergic to acetaminophen (Tylenol) or codeine, or other narcotic pain relievers such as fentanyl (Actiq, Duragesic), hydrocodone (Vicodin), hydromorphone (Dilaudid, Palladone), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), or oxymorphone (Opana).

Before using acetaminophen and codeine, tell your doctor if you are allergic to any drugs, or if you have:

• asthma, COPD, sleep apnea, or other breathing disorders;

• liver disease;

• kidney disease;

• underactive thyroid;

• a history of head injury or brain tumor;

• epilepsy or other seizure disorder;

• low blood pressure;

• a stomach or intestinal disorder;

• Addison’s disease or other adrenal gland disorders;

• enlarged prostate, urination problems;

• mental illness; or

• a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use acetaminophen and codeine, or you may need a dosage adjustment or special tests during treatment.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Codeine may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and codeine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Keep track of how many tablets have been used from each new bottle of this medicine. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Acetaminophen and codeine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone younger than 18 years old.

Older adults may be more sensitive to the effects of this medicine.

Your pharmacist has information about acetaminophen and codeine written for health professionals that you may read.

Acetaminophen and codeine is available with a prescription generically and under the brand name Tylenol with Codeine. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Acetaminophen/codeine strengths are as follows:

• Tylenol with Codeine No. 2 300 mg/15 mg—round, white tablets

• Tylenol with Codeine No. 3 300 mg/30 mg—round, white tablets

• Tylenol with Codeine No. 4 300 mg/60 mg—round white tablets

• Tylenol with Codeine Elixir 120 mg/12 mg per 5 mL (1 tsp)—amber-colored, cherry-flavored liquid containing 7% alcohol