Codeine, phenylephrine, and promethazine

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.

You should not use this medicine if you have asthma, pneumonia or other lung problems, high blood pressure, blood circulation problems, or if you have used an MAO inhibitor in the past 14 days.

This medicine should not be used to treat cold or flu symptoms in anyone younger than 6 years old, and should not be used as a pain medicine in children younger than 12 or anyone under 18 who recently had surgery to remove the tonsils or adenoids.

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

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

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.

You should not use codeine, phenylephrine, and promethazine if you are allergic to it, or if you have:

• asthma, pneumonia, or other lung problems;

• high blood pressure; or

• blood circulation problems.

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.

This medicine should not be used to treat cold or flu symptoms in anyone younger than 6 years old.

Codeine, phenylephrine, and promethazine should not be used as a pain medicine in children younger than 12 or anyone under 18 who recently had surgery to remove the tonsils or adenoids.

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

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

• drug or alcohol addiction;

• a seizure disorder, head injury, or a brain tumor;

• stomach problems;

• severe or ongoing cough;

• diabetes;

• a thyroid disorder;

• heart disease;

• a blood cell disorder;

• glaucoma;

• Addison's disease (an adrenal gland disorder);

• enlarged prostate, problems with urination;

• liver or kidney disease; or

• surgery (recent or planned).

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. Promethazine may slow breast milk production.

Follow all directions on your prescription label. Codeine and promethazine can slow or stop your breathing. Never use this medicine 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.

You should not use antihistamine medication to make a child sleepy.

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.

Do not take for longer than 7 days in a row. Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you have used a cough or cold medicine in the past few days.

Store at room temperature away from moisture, heat, and light. Do not freeze.

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.

This medicine 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 while you are taking medicine that contains codeine. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any cold, cough, or sleep medication. Many combination medicines contain antihistamines, decongestants, or cough suppressants. Taking certain products together can cause you to get too much of these medicines.

Avoid exposure to sunlight or tanning beds. This medicine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Taking codeine, phenylephrine, and promethazine 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.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• medicine to treat mental illness;

• medicine to treat a stomach or intestinal disorder; or

• cold or allergy medicine that contains an antihistamine.

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

Less than 12 years of age: Contraindicated

12 years and older:
Average effective dose: 5 mL orally every 4 to 6 hours as needed
Maximum dose: 30 mL (promethazine 37.5 mg; phenylephrine: 30 mg; codeine: 60 mg) in 24 hours

Comments:
-Each 5 mL contains Promethazine 6.25 mg/Phenylephrine 5 mg/Codeine 10 mg.
-Liquid preparations should be measured with an accurate milliliter measuring device.
-Codeine should not be used in adolescents who are obese or have conditions such as sleep apnea or severe lung disease which may increase the risk of serious breathing problems.

Uses: Temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Use with caution, especially in patients with severe renal impairment

Data not available