Guaifen DAC

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.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Codeine, guaifenesin, and pseudoephedrine is a combination medicine used to treat cough, stuffy nose, and sinus 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, guaifenesin, and pseudoephedrine may also be used for purposes not listed in this medication guide.

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.

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

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.

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