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, Coditussin DAC, 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, Tusnel C, 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
• Frequently drink alcohol
• Head injury
• Heart disease
• High blood pressure
• Kidney disease
• Liver disease
• Lung disease or breathing disease, such as asthma or COPD
• Prostate disease
• Seizures
• Stomach or intestine problems
• Substance use disorder
• Taken an MAOI, such as 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
• Breastfeeding

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. There may be unused or extra doses in the bottle after you finish your treatment. Talk to your care team if you have questions about your dose.

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

People 65 years and older 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, such as 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, such as amitriptyline, fluoxetine, or sertraline
• Certain medications for seizures, such as phenobarbital or primidone
• General anesthetics, such as halothane, isoflurane, methoxyflurane, propofol
• Medications that relax muscles for surgery
• Opioids for pain
• Phenothiazines, such as chlorpromazine, mesoridazine, prochlorperazine, or 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?

You may develop tolerance to this medication if you take it for a long time. Tolerance means that you will get less symptom relief with time. Tell your care team if your symptoms do not start to get better or if they get worse.

Taking this medication with other substances that cause drowsiness, such as alcohol, benzodiazepines, or other opioids can cause serious side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Call emergency services if you have problems breathing or staying awake.

Long term use of this medication may cause your brain and body to depend on it. This can happen even when used as directed by your care team. You and your care team will work together to determine how long you will need to take this medication. If your care team wants you to stop this medication, the dose will be slowly lowered over time to reduce the risk of side effects.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

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.

Talk to your care team if you may be pregnant. Prolonged use of this medication during pregnancy can cause temporary withdrawal in a newborn.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, seek medical care right away if you notice the child has slow or noisy breathing, is unusually sleepy or not able to wake up, or is limp.

Long-term use of this medication may cause infertility. Talk to your care team if you are concerned about your fertility.

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 this medication out of reach of children and pets. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 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. To get rid of this medication:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication.
• If other options are not available, check the package insert or medication guide to see if it should be flushed down the toilet or put in your trash at home. If you are not sure, ask your care team. If it is safe to put it in your trash, empty the medication out of the container. Mix it with cat litter, dirt, used coffee grounds, or another unwanted substance. Seal the mixture in a container, such as a plastic bag. 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.