Codeine Oral (patient information)

IMPORTANT WARNING

[Posted 01/12/2007] The Centers for Disease Control and Prevention (CDC) issued a Morbidity and Mortality Weekly Report (MMWR) article describing three deaths in U.S. infants aged less than 12 months associated with cough and cold medications. These medications were determined by medical examiners or coroners to be the underlying cause of death. The cases described in this report underscore the need for clinicians to use caution when prescribing and caregivers to use caution when administering cough and cold medications to children aged less than 2 years. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#coughcold and http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm.

Why this medication is prescribed

Codeine is used, usually in combination with other medications, to reduce coughing. It also is used to relieve mild to moderate pain.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How this medication should be used

Codeine comes alone or in combination with other drugs as a tablet, capsule, and liquid to take by mouth. It usually is taken every 4-6 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take codeine exactly as directed.

Codeine can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

Shake the liquid well before measuring a dose.

Special precautions

Before taking codeine:

• tell your doctor and pharmacist if you are allergic to codeine or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially other pain relievers; antidepressants; medications for cough, cold, or allergies; sedatives; sleeping pills; tranquilizers; and vitamins.
• tell your doctor if you have or have ever had liver, kidney, or lung disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking codeine, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking codeine.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug.

What to do if you forget a dose

Codeine usually is taken as needed. If your doctor has told you to take codeine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Minor side effects

Codeine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• lightheadedness
• drowsiness
• upset stomach
• vomiting
• constipation
• stomach pain
• rash
• difficulty urinating

Severe side effects

If you experience either of the following symptoms, call your doctor immediately:

• difficulty breathing
• mood changes

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

See the MedWatch notification at the beginning of the monograph.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Other information

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Brontex®
• Cheracol® with Codeine Syrup
• Gani-Tuss® NR
• Guiatuss AC® Syrup
• Guiatussin® with Codeine
• HaNew Riversin® AC
• Mytussin® AC Cough Syrup
• Robafen AC® Syrup
• Robitussin A-C® Syrup
• Tussi-Organidin® NR
• Tussi-Organidin®-S NR

Brand names of combination products

• Ambenyl® Cough Syrup containing Codeine Phosphate and Bromodiphenhydramine Hydrochloride
• Bromanyl® Cough Syrup containing Codeine Phosphate and Bromodiphenhydramine Hydrochloride
• Codimal® PH Syrup containing Codeine Phosphate, Phenylephrine Hydrochloride, and Pyrilamine Maleate
• Colrex® Compound containing Codeine Phosphate, Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride
• Cycofed® Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Cycofed® Expectorant Pediatric containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Decohistine® DH containing Codeine Phosphate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
• Decohistine® Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Dihistine® DH Elixir containing Codeine Phosphate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
• Dihistine® Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Guaifenesin DAC® containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Guiatuss DAC® Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Guiatussin® DAC Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• HaNew Riversin® DAC containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• KG-Fed® Expectorant Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• KG-Fed® Pediatric Expectorant Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• KG-Fed® Syrup containing Codeine Phosphate and Pseudoephedrine Hydrochloride
• Mytussin® DAC containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Novahistine® DH containing Codeine Phosphate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
• Novahistine® Expectorant with Codeine containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Nucofed® containing Codeine Phosphate and Pseudoephedrine Hydrochloride
• Nucofed® Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Nucofed® Pediatric Expectorant Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Nucofed® Syrup containing Codeine Phosphate and Pseudoephedrine Hydrochloride
• Nucotuss® Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Nucotuss® Pediatric Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Pediacof® Cough Syrup containing Codeine Phosphate, Chlorpheniramine Maleate, Phenylephrine Hydrochloride, and Potassium Iodide
• Phenergan® VC with Codeine Syrup containing Codeine Phosphate, Phenylephrine Hydrochloride, and Promethazine Hydrochloride
• Phenergan® with Codeine Syrup containing Codeine Phosphate and Promethazine Hydrochloride
• Phenhist® DH with Codeine Modified Formula containing Codeine Phosphate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
• Prometh® VC with Codeine Phosphate Cough Syrup containing Codeine Phosphate, Phenylephrine Hydrochloride, and Promethazine Hydrochloride
• Robitussin®-DAC containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Ryna-C® containing Codeine Phosphate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
• Ryna-CX® containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Triacin-C® Cough Syrup containing Codeine Phosphate, Pseudoephedrine Hydrochloride, and Triprolidine Hydrochloride
• Tussar® SF Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
• Tussar®-2 Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride