Cheratussin DAC

• Qualitest Pharmaceuticals, Inc,

• Vintage Pharmaceuticals, Inc.

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.

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

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

Do not take for longer than 7 days in a row. 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.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

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.

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking codeine, guaifenesin, and pseudoephedrine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

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