Codeine and pseudoephedrine

Generic name: codeine and pseudoephedrine [ KOE-deen-and-SOO-doe-ee-FED-rin ]
Brand names: Codar D, Nucofed, KG-Fed, Cycofed, Nucodine, Notuss-DC, EndaCof-DC
Dosage form: oral liquid (8 mg-30 mg/5 mL)
Drug class: Upper respiratory combinations

What is codeine and pseudoephedrine?

Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Codeine and pseudoephedrine is a combination medicine used to treat cough, stuffy nose, and sinus congestion caused by allergies or the common cold.

codeine and pseudoephedrine will not treat a cough that is caused by smoking, asthma, or emphysema.

Codeine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

Warnings

Codeine can slow or stop your breathing, 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.

This medicine is not for use in anyone under 18.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Before taking this medicine

You should not use codeine and pseudoephedrine if you are allergic to codeine or pseudoephedrine.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

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 this medicine to anyone younger than 18 years old.

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

• heart disease or high blood pressure;

• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;

• diabetes;

• cough with mucus, or cough caused by emphysema or chronic bronchitis;

• thyroid disorder; or

• an enlarged prostate or urination problems.

If you use codeine 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. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.

How should I take codeine and pseudoephedrine?

Use exactly as directed on the label, or as prescribed by your doctor. Codeine can slow or stop your breathing. Never use codeine and pseudoephedrine in larger amounts, or for longer than prescribed. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

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.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since codeine and pseudoephedrine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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 symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid while taking codeine and pseudoephedrine?

codeine and pseudoephedrine 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.

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

Ask a doctor or pharmacist before using any other cough or cold medicine. Many combination medicines contain decongestants or cough suppressants. Taking certain products together can cause you to get too much of a certain drug.

Codeine and pseudoephedrine side effects

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

Like other narcotic medications, 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.

Stop using codeine and pseudoephedrine and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing;

• a slow heart rate or weak pulse;

• severe dizziness or drowsiness;

• severe restlessness; or

• severe constipation.

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

Common side effects may include:

• drowsiness;

• blurred vision; or

• constipation.

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.

Codeine and pseudoephedrine dosing information

Usual Adult Dose for Cough and Nasal Congestion:

Usual dose: 10 mL orally every 4 to 6 hours as needed
Maximum dose: Codeine 64 mg/pseudoephedrine 240 mg (40 mL) per 24 hours

Comments:
-Each 5 mL contains codeine 8 mg/pseudoephedrine 30 mg.
-Oral liquid should be measured with an accurate milliliter measuring device.

Uses: Temporary relief of coughs due to the common cold, allergic rhinitis or other upper respiratory allergies; reduces swelling of nasal passages to relieve nasal congestion.

What other drugs will affect codeine and pseudoephedrine?

Taking codeine and pseudoephedrine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with codeine and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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