Codeine is an opioid pain reliever which is used to treat mild to moderately severe pain and to help reduce coughing. Codeine is available as a single ingredient tablet and also available in multi ingredients products combined with other pain relieving medicines or cold and flu medicines.

You should not use codeine if you have severe breathing problems, a blockage in your stomach or intestines, or frequent asthma attacks or hyperventilation.

Codeine can slow or stop your breathing, cause profound sedation, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Codeine is not for use in anyone under 18 years old.

Taking codeine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use codeine with alcohol, or with other drugs that cause drowsiness, sedation or slow your breathing.

Before taking this medicine

You should not use this medicine if you are allergic to it, or if you have:

• severe asthma or breathing problems;

• a blockage in your stomach or intestines; or

• frequent asthma attacks or hyperventilation.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Do not give codeine to anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver disease;

• breathing problems, sleep apnea;

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

• abnormal curvature of the spine that affects breathing;

• kidney disease;

• a head injury or brain tumor;

• low blood pressure;

• blockage in your digestive tract (stomach or intestines);

• a gallbladder or pancreas disorder;

• underactive thyroid;

• Addison's disease or other adrenal gland disorder;

• enlarged prostate, urination problems; or

• mental illness, drug or alcohol addiction.

Some medicines can interact with codeine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use this medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while taking codeine. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

Take codeine exactly as prescribed by your doctor. Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

Take this medicine with food or milk if it upsets your stomach.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking this medicine. Do not use a stool softener (laxative) without first asking your doctor.

Do not stop using codeine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag throw the bag in the trash.

Usual Adult Dose for Pain:

Initial dose: 15 to 60 mg orally up to every 4 hours as needed
Maximum dose: 360 mg in 24 hours

Comments:
-Initial doses should be individualized taking into account severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
-Doses higher than 60 mg have not been shown to improve pain relief and are associated with an increased incidence of adverse effects.
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the management of mild to moderate pain where treatment with an opioid is appropriate and from which alternative treatments are inadequate.

You should not use this medicine if you are allergic to it, or if you have:

• severe asthma or breathing problems;

• a blockage in your stomach or intestines; or

• frequent asthma attacks or hyperventilation.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Do not give codeine to anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver disease;

• breathing problems, sleep apnea;

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

• abnormal curvature of the spine that affects breathing;

• kidney disease;

• a head injury or brain tumor;

• low blood pressure;

• blockage in your digestive tract (stomach or intestines);

• a gallbladder or pancreas disorder;

• underactive thyroid;

• Addison's disease or other adrenal gland disorder;

• enlarged prostate, urination problems; or

• mental illness, drug or alcohol addiction.

Some medicines can interact with codeine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use this medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while taking codeine. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A codeine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose can cause severe muscle weakness, cold and clammy skin, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Do not drink alcohol. Dangerous side effects or death could occur.

Codeine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Get emergency medical help if you have signs of an allergic reaction to codeine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, codeine can slow your breathing. Death may occur if breathing becomes too weak.

A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

• a slow heart rate or weak pulse;

• a light-headed feeling, like you might pass out;

• confusion, agitation, hallucinations, unusual thoughts or behavior;

• feelings of extreme happiness or sadness;

• seizure (convulsions);

• problems with urination; or

• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common codeine side effects include:

• feeling dizzy or drowsy;

• nausea, vomiting, stomach pain;

• constipation;

• sweating; or

• mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body- a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Keep all appointments with your doctor and laboratory. Your doctor will order certain lab tests to check your body's response to codeine.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking codeine.

Selling or giving away this medication may cause death or harm to others and is illegal. Your prescription might not be refillable. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Airacof® (containing Codeine, Diphenhydramine, Phenylephrine)
• Ala-Hist AC® (containing Codeine, Phenylephrine)
• Allfen CD® (containing Codeine, Guaifenesin)
• Ambenyl® (containing Bromodiphenhydramine, Codeine)
• Ambophen® (containing Bromodiphenhydramine, Codeine)
• Antituss AC® (containing Codeine, Guaifenesin)
• Bitex® (containing Codeine, Guaifenesin)
• Bromanyl® (containing Bromodiphenhydramine, Codeine)
• Bromotuss® with Codeine (containing Bromodiphenhydramine, Codeine)
• Brontex® (containing Codeine, Guaifenesin)
• Bron-Tuss® (containing Codeine, Guaifenesin)
• Brovex CB® (containing Brompheniramine, Codeine)
• Brovex PBC® (containing Brompheniramine, Codeine, Phenylephrine)
• Calcidrine® (containing Anhydrous Calcium Iodide, Codeine)
• Cheracol® with Codeine (containing Codeine, Guaifenesin)
• Cheratussin® (containing Codeine, Guaifenesin)
• Codafen® (containing Codeine, Guaifenesin)
• Codimal PH® (containing Codeine, Phenylephrine, Pyrilamine)
• Cotab A® (containing Chlorpheniramine, Codeine)
• Demi-Cof® (containing Chlorpheniramine, Codeine, Phenylephrine, Potassium Iodide)
• Dex-Tuss® (containing Codeine, Guaifenesin)
• Diabetic Tussin C® (containing Codeine, Guaifenesin)
• Dicomal-PH® (containing Codeine, Phenylephrine, Pyrilamine)
• Duraganidin NR® (containing Codeine, Guaifenesin)
• EndaCof AC® (containing Brompheniramine, Codeine)
• Endal CD® (containing Codeine, Diphenhydramine, Phenylephrine)
• ExeClear-C® (containing Codeine, Guaifenesin)
• Gani-Tuss NR® (containing Codeine, Guaifenesin)
• Giltuss Ped-C® (containing Codeine, Guaifenesin, Phenylephrine)
• Glydeine® (containing Codeine, Guaifenesin)
• Guaifen AC® (containing Codeine, Guaifenesin)
• Guiatuss AC® (containing Codeine, Guaifenesin)
• Guiatussin® with Codeine (containing Codeine, Guaifenesin)
• Halotussin AC® (containing Codeine, Guaifenesin)
• Iophen® (containing Codeine, Guaifenesin)
• Mar-cof CG® (containing Codeine, Guaifenesin)
• Maxiphen CD® (containing Codeine, Guaifenesin, Phenylephrine)
• M-Clear WC® (containing Codeine, Guaifenesin)
• M-End PE® (containing Brompheniramine, Codeine, Phenylephrine)
• Mytussin AC® (containing Codeine, Guaifenesin)
• Nalex® AC (containing Brompheniramine, Codeine)
• Notuss AC® (containing Chlorpheniramine, Codeine)
• Notuss PE® (containing Codeine, Phenylephrine)
• Pediacof® (containing Chlorpheniramine, Codeine, Phenylephrine, Potassium Iodide)
• Pedituss® (containing Chlorpheniramine, Codeine, Phenylephrine, Potassium Iodide)
• Pentazine VC® (containing Codeine, Phenylephrine, Promethazine)
• Pentazine® with Codeine (containing Codeine, Promethazine)
• Phenergan® VC with Codeine (containing Codeine, Phenylephrine, Promethazine)
• Phenergan® with Codeine (containing Codeine, Promethazine)
• Poly-Tussin AC® (containing Brompheniramine, Codeine, Phenylephrine)
• Prometh® with Codeine (containing Codeine, Guaifenesin, Promethazine)
• Robafen AC® (containing Codeine, Guaifenesin)
• Robichem AC® (containing Codeine, Guaifenesin)
• Robitussin® AC (containing Codeine, Guaifenesin)
• Rolatuss® (containing Ammonium Chloride, Chlorpheniramine, Codeine, Phenylephrine)
• Romilar AC® (containing Codeine, Guaifenesin)
• Tusnel C® (containing Brompheniramine, Codeine, Guaifenesin)
• Tussi Organidin® (containing Codeine, Guaifenesin)
• Tussiden C® (containing Codeine, Guaifenesin)
• Tussirex® (containing Caffeine, Codeine, Pheniramine, Phenylephrine, Salicylic Acid)
• Tusso-C® (containing Codeine, Guaifenesin)
• Vanacof® (containing Codeine, Dexchlorpheniramine, Phenylephrine)
• Z Tuss AC® (containing Chlorpheniramine, Codeine)
• Zodryl AC® (containing Chlorpheniramine, Codeine)
• Zotex C® (containing Codeine, Phenylephrine, Pyrilamine)