Relcof C

Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Codeine and guaifenesin is a combination medicine used to treat cough and chest congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Codeine and guaifenesin may also be used for purposes not listed in this medication guide.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

Stop using this medicine and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing;

• a slow heart rate or weak pulse;

• severe dizziness or drowsiness;

• confusion, hallucinations, unusual thoughts or behavior;

• little or no urinating;

• severe constipation; or

• slow heart rate, weak or shallow breathing.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects may include:

• constipation; or

• mild drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to codeine / guaifenesin: oral liquid, oral solution, oral syrup

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 Relcof C may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.