Codeine; Guaifenesin; Pseudoephedrine Solution

What is this medication?

CODEINE; GUAIFENESIN; PSEUDOEPHEDRINE (KOE deen; gwye FEN e sin; soo doe e FED rin) treats the symptoms of the common cold, allergies, or flu. It works by reducing cough, loosening mucus, and decreasing a runny or stuffy nose. It is a combination of an opioid cough suppressant, an expectorant, and a decongestant.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): C Tussin, Cheratussin DAC, Codafed Expectorant, Codafed Pediatric Expectorant, Cophene-X-P, Cycofed Expectorant, Cycofed Pediatric Expectorant, Decohistine, Dihistine Expectorant, Guaiatussin DAC, Guiatuss DAC, Halotussin DAC, Lortuss EX, Mytussin DAC, Nucofed Expectorant, Nucofed Pediatric Expectorant, Nucotuss Expectorant, Phenylhistine Expectorant, Robafen DAC, Sudatuss 2, Sudatuss SF, Suttar, Virtussin DAC, Z-Tuss E

What should I tell my care team before I take this medication?

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

• Brain tumor
• Diabetes (high blood sugar)
• Drug abuse or addiction
• Head injury
• Heart disease
• High blood pressure
• If you often drink alcohol
• Kidney disease
• Liver disease
• Lung disease, asthma, or breathing problem
• Prostate disease
• Seizures
• Stomach or intestine problems
• Taken an MAOI like Marplan, Nardil, or Parnate in last 14 days
• Thyroid disease
• An unusual or allergic reaction to codeine, guaifenesin, pseudoephedrine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the label. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take it with or without food. If it upsets your stomach, take it with food. Do not use it more often than directed.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use. It should only be used as needed.

What may interact with this medication?

Do not take this medication with any of the following:

• Linezolid
• MAOIs like Marplan, Nardil, and Parnate
• Methylene blue
• Ozanimod

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough, and cold
• Certain medications for anxiety or sleep
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for seizures like phenobarbital, primidone
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Medications that relax muscles for surgery
• Narcotic medications for pain
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. If you need to use this medication for more than 7 days, talk to your care team.

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

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

If you take other medications that also cause drowsiness such as other narcotic pain medications, benzodiazepines, or other medications for sleep, you may have more side effects. Give your care team a list of all medications you use. He or she will tell you how much medication to take. Do not take more medication than directed. Get emergency help right away if you have problems breathing or are unusually tired or sleepy.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication 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 medication. Avoid alcoholic drinks.

This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

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

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

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

• Anxiety or nervousness
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Nausea
• Trouble sleeping
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

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

Store between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it, or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.