Cheratussin AC

You should not take this medicine if you are allergic to codeine or guaifenesin.

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.

Ask a doctor before giving this medicine to a child younger than 12 years old.

Medicines that contain codeine should not be used in anyone under 18 who recently had surgery to remove the tonsils or adenoids.

To make sure codeine and guaifenesin is safe for you, tell your doctor if you have ever had:

• a cough with mucus;

• asthma, COPD, or other breathing disorder;

• blockage in your digestive tract (stomach or intestines);

• a head injury or brain tumor;

• low blood pressure; or

• drug or alcohol addiction.

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. Do not breast-feed.

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use codeine and guaifenesin 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 or skin rash.

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

Since codeine and guaifenesin 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.

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.

• If you have an allergy to guaifenesin, codeine, or any other part of Cheratussin AC.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you have a cough with a lot of mucous.
• If you have a long-term cough caused by smoking or being around smoke, or lung problems like asthma or emphysema.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you are breast-feeding. Do not breast-feed while you take Cheratussin AC.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cheratussin AC with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Trouble breathing, slow breathing, or shallow breathing.
• Noisy breathing.
• Feeling very sleepy.
• Feeling confused.
• A heartbeat that does not feel normal.
• Hallucinations (seeing or hearing things that are not there).
• Mood changes.
• Seizures.
• Very bad belly pain.
• Very bad headache.
• Trouble passing urine.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Very hard stools (constipation).
• Feeling very tired or weak.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hard stools (constipation).
• Dizziness.
• Feeling sleepy.
• Upset stomach or throwing up.
• Sweating a lot.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to codeine / guaifenesin: oral capsule, oral liquid, oral syrup, oral tablet

General

The more commonly reported adverse effects of codeine include nausea, vomiting, and diarrhea. Guaifenesin is generally well tolerated.

Nervous system

Codeine
Frequency not reported: CNS depression, lightheadedness, dizziness, sedation, headache, convulsions, weakness[Ref]

Cardiovascular

Codeine
Frequency not reported: Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension, circulatory depression

Gastrointestinal

Codeine
Frequency not reported: Nausea, vomiting, constipation, biliary tract spasm, increased colonic motility, toxic dilation

Guaifenesin:
Frequency not reported: Abdominal pain (upper), diarrhea, nausea, vomiting[Ref]

Genitourinary

Codeine
Frequency not reported: Oliguria, urinary retention, antidiuretic effect[Ref]

Dermatologic

Codeine-induced rash may be related to direct stimulation of histamine release.[Ref]

Codeine:
Frequency not reported: Rash

Guaifenesin:
Frequency not reported: Rash[Ref]

Hypersensitivity

Codeine
Frequency not reported: Pruritus, giant urticaria, angioneurotic edema, laryngeal edema

Guaifenesin:
Frequency not reported: Hypersensitivity reactions (pruritus, urticaria)

Ocular

Codeine
Frequency not reported: Visual disturbances

Psychiatric

Codeine
Frequency not reported: Euphoria, dysphoria, transient hallucination, disorientation

Respiratory

Codeine:
Frequency not reported: Respiratory depression[Ref]

Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy. Further investigation has shown these patients to be ultra-rapid metabolizers of codeine. Children with obstructive sleep apnea who are treated with codeine appear to be particularly sensitive to the respiratory depressant effects of codeine.[Ref]

Some side effects of Cheratussin AC may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.