Codeine and dexbrompheniramine

Codeine and dexbrompheniramine is a combination medicine used for a short time to treat a runny nose, sneezing, an itchy nose or throat, watery eyes, and cough caused by a cold or allergies (hay fever).

Codeine and dexbrompheniramine may also be used for reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Cold or cough medicine is only for short-term use.

Follow all directions when giving this medicine to a child. Do not use the medicine to make a child sleepy. Misuse of this medicine may cause death in very young children.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Do not use this medicine more often than directed.

Call your doctor if your symptoms do not improve after 7 days, or if you have a cough or nasal congestion that will not stop, fever, rash, or headaches.

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.

Store at room temperature away from moisture and heat.

Do not use if you are taking a MAO inhibitor (certain antibiotics or medicines for anxiety, mood disorders, or Parkinson's disease), or for 2 weeks after stopping a MAO inhibitor. A dangerous drug interaction could occur. Tell your doctor about all other medicines you use before taking codeine and dexbrompheniramine.

You should not use codeine and dexbrompheniramine if you are allergic to codeine and dexbrompheniramine.

Do not use if you are taking a MAO inhibitor (certain antibiotics or medicines for anxiety, mood disorders, or Parkinson's disease), or for 2 weeks after stopping a MAO inhibitor. A dangerous drug interaction could occur. Tell your doctor about all other medicines you use before taking codeine and dexbrompheniramine.

Ask a doctor or pharmacist if this medicine is safe to use if you have or have ever had:

• an enlarged prostate or urination problems;
• glaucoma;
• a breathing problem such as emphysema, or chronic bronchitis;
• cough with severe mucus, or cough caused by asthma, smoking, or emphysema;
• heart disease;
• high blood pressure;
• a thyroid disorder; or
• diabetes.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Codeine and dexbrompheniramine should not be given to a child younger than 6 years old.

Do not allow any child to use codeine and dexbrompheniramine without help from an adult.

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

Codeine and dexbrompheniramine may cause serious side effects. Stop using codeine and dexbrompheniramine and call your doctor right away if you have:

• new or worsening symptoms like cough or nasal congestion; or
• fever, rash, headache.

Common side effects of codeine and dexbrompheniramine may include:

• feeling restless or excited (especially in children);
• drowsiness; or
• constipation.

This is not a complete list of side effects and others may happen. 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 Cough:

Maintenance dose: 10 mL orally every 4 to 6 hoursMaximum dose: 60 mL in 24 hoursUses: Temporary relief of cough due to minor throat and bronchial irritation, runny nose, sneezing, itchy nose or throat, itchy watery, nasal congestion, and reduction of swelling of nasal passages

Usual Pediatric Dose for Cough:

6 to 12 years:Maintenance dose: 5 mL orally every 4 hoursMaximum dose: 30 mL in 24 hours12 years and older:Maintenance dose: 10 mL orally every 4 to 6 hoursMaximum dose: 60 mL in 24 hoursUses: Temporary relief of cough due to minor throat and bronchial irritation, runny nose, sneezing, itchy nose or throat, itchy watery, nasal congestion, and reduction of swelling of nasal passages

Codeine and dexbrompheniramine is used as needed. If you miss a dose while on a dosing schedule, skip it. Do not take two doses at once.

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 another person using the medicine without a prescription.

Drinking alcohol with codeine and dexbrompheniramine can cause side effects.

Avoid driving or doing anything dangerous until you know how this medicine will affect you. Your reactions could be impaired.

Ask a doctor or pharmacist before taking other cough or cold medicines that may have similar ingredients.

Ask a doctor or pharmacist before using any other medicines that can cause drowsiness (such as opioid medication, sleep medicine, a muscle relaxer, or medicine for anxiety or seizures). Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.