Codeine, guaifenesin, and pseudoephedrine

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, confusion, hallucinations, cold and clammy skin, pinpoint pupils, and fainting.

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

• noisy breathing, sighing, shallow breathing;

• severe drowsiness, hallucinations;

• fast, slow, or uneven heart rate;

• a seizure;

• nervousness, tremors; or

• little or no urination.

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

Common side effects may include:

• dizziness, drowsiness, weakness;

• headache;

• nausea, constipation;

• sleep problems (insomnia); or

• feeling nervous, anxious, or restless.

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.

Usual Adult Dose for Cold Symptoms:

1 dose orally every 4 to 6 hours as needed
-Codeine: Single dose: up to 20 mg; Maximum daily dose: 120 mg in 24 hours
-Guaifenesin: Single dose: up to 400 mg; Maximum daily dose: 2400 mg in 24 hours
-Pseudoephedrine: Single dose: up to 60 mg; Maximum daily dose: 240 mg in 24 hours

Comments:
-Maximum dose should not exceed maximum dose of any of the single ingredient doses.
-Oral liquid should be measured with an accurate milliliter measuring device.

Uses: Temporary relief of coughs due to the common cold, allergic rhinitis or other upper respiratory allergies; reduces swelling of nasal passages to relieve nasal congestion and helps loosen mucus and thin bronchial secretions to make cough more productive.

Usual Pediatric Dose for Cold Symptoms:

Less than 12 years: Not recommended

12 years or older:
1 dose orally every 4 to 6 hours as needed
-Codeine: Single dose: up to 20 mg; Maximum dose: 120 mg in 24 hours
-Guaifenesin: Single dose: up to 400 mg; Maximum dose: 2400 mg in 24 hours
-Pseudoephedrine: Single dose: up to 60 mg; Maximum dose: 240 mg in 24 hours

Comments:
- Maximum doses should not exceed any of the single or maximum daily doses.
-Oral liquid should be measured with an accurate milliliter measuring device.
-Codeine should not be used in adolescents who are obese or have conditions such as sleep apnea or severe lung disease which may increase the risk of serious breathing problems.

Uses: Temporary relief of coughs due to the common cold, allergic rhinitis or other upper respiratory allergies; reduces swelling of nasal passages to relieve nasal congestion and helps loosen mucus and thin bronchial secretions to make cough more productive.

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:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Hard stools (constipation).
• 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 / pseudoephedrine: oral liquid, oral tablet

General

The more commonly expected adverse effects include nausea, vomiting, and dizziness.[Ref]

Nervous system

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

Pseudoephedrine:
Frequency not reported: Restlessness, dizziness, weakness, headache, drowsiness, tremor[Ref]

Cardiovascular

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

Pseudoephedrine:
Frequency not reported: Tachycardia, palpitations, cardiac arrhythmias, hypertension, impaired circulation to the extremities, coronary artery spasm, chest pain[Ref]

Hypotension is rare and has been reported most frequently with high doses of codeine.

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]

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

Pseudoephedrine:
Frequency not reported: Nausea, vomiting, dry mouth, ischemic colitis[Ref]

Patients with chronic ulcerative colitis may experience increased colonic motility, while patients with acute ulcerative colitis have experienced toxic dilation with codeine use.[Ref]

Genitourinary

Codeine
Frequency not reported: Oliguria, urinary retention, antidiuretic effect

Pseudoephedrine:
Frequency not reported: Urinary retention[Ref]

Hypersensitivity

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

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

Pseudoephedrine:
Frequency not reported: Fixed drug eruptions[Ref]

Dermatologic

Codeine:
Frequency not reported: Rash

Guaifenesin:
Frequency not reported: Rash

Pseudoephedrine:
Frequency not reported: Fixed drug eruption in the form of erythematous nodular patches, rash[Ref]

Ocular

Codeine
Frequency not reported: Visual disturbances

Pseudoephedrine:
Frequency not reported: Angle-closure glaucoma

Psychiatric

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

Pseudoephedrine:
Frequency not reported: Hallucinations (particularly in children), anxiety, excitability, insomnia

Respiratory

Respiratory depression has been associated with antitussive use of codeine in young children. 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.

Codeine:
Frequency not reported: Respiratory depression

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