Codeine; Guaifenesin; Pseudoephedrine oral solution or syrup

What is this medicine?

CODEINE; GUAIFENESIN; PSEUDOEPHEDRINE (KOE deen; gwye FEN e sin; soo doe e FED rin) is a cough suppressant, expectorant, and decongestant combination. It is used to treat cough and congestion. This medicine will not treat an infection.

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years old for selected conditions, precautions do apply.

Patients over 60 years old may have a stronger reaction and need a smaller dose.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in blood pressure

• changes in vision

• confusion

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• hallucinations

• irritable or excited

• seizures

• trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• dry mouth, nose, or throat

• headache

• loss of appetite

• nausea, vomiting

• tiredness

• unusual sweating

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alcohol

• barbiturates like phenobarbital

• certain medicines for anxiety or sleep

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• other narcotic medicines for pain or cough

• stimulant medicines for attention disorders, weight loss, or to stay awake

• tramadol

This medicine may also interact with the following medications:

• antihistamines for allergy, cough and cold

• certain medicines for seizures like carbamazepine, phenytoin

• medicines for blood pressure

• medicines for depression, anxiety, or psychotic disturbances

• medicines for heart problems

• muscle relaxants

• naltrexone

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

This medicine may cause accidental overdose and death if taken by other adults, children, or pets. Mix any unused medicine with a substance like cat littler or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• drug abuse or addiction

• glaucoma

• heart disease

• high blood pressure

• intestinal problems

• kidney disease

• liver disease

• lung disease, asthma, or breathing problems

• stomach ulcer

• thyroid disease

• trouble passing urine

• an unusual or allergic reaction to codeine, guaifenesin, pseudoephedrine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Use exactly as directed by your doctor or health care professional. Do not take more than the recommended dose. You may develop tolerance to this medicine if you take it for a long time. Tolerance means that you will get less cough relief with time. Tell your doctor or health care professional if your symptoms do not improve or if they get worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Children may be at higher risk for side effects. If your child has slow breathing, noisy breathing, confusion, or unusual sleepiness, stop giving this medicine and get medical help right away.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

If you have been taking this medicine for a long time, do not suddenly stop taking it because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a nonmedical reason. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.