Chlorpheniramine, dextromethorphan, and pseudoephedrine

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not use chlorpheniramine, dextromethorphan, and pseudoephedrine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure this medicine is safe for you, tell your doctor if you have:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• a blockage in your digestive tract (stomach or intestines);

• high blood pressure, heart disease;

• liver or kidney disease;

• glaucoma;

• cough with mucus, or cough caused by emphysema or chronic bronchitis;

• enlarged prostate or urination problems;

• pheochromocytoma (an adrenal gland tumor);

• overactive thyroid; or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

FDA pregnancy category C. It is not known whether chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

This medicine can pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

• confusion, severe anxiety, hallucinations, tremors;

• weak or shallow breathing;

• a light-headed feeling, like you might pass out;

• fast or pounding heartbeats;

• painful or difficult urination, little or no urinating;

• pale skin, weakness, easy bruising or bleeding, fever, chills, body aches; or

• increased blood pressure--severe headache, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats.

Common side effects may include:

• dizziness, drowsiness, headache;

• constipation, upset stomach, loss of appetite;

• blurred vision, double vision, dry eyes;

• sleep problems (insomnia); or

• dry mouth, nose, or throat.

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 Cough and Nasal Congestion:

chlorpheniramine/dextromethorphan/PSE 2 mg-15 mg-15 mg/5 mL oral liquid: 10 mL orally four times daily

chlorpheniramine/dextromethorphan/PSE 4 mg-30 mg-30 mg/5 mL oral suspension, extended release or
chlorpheniramine/dextromethorphan/PSE 6 mg-30 mg-30 mg/5 mL oral suspension, extended release or
chlorpheniramine/dextromethorphan/PSE 5 mg-25 mg-75 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours

chlorpheniramine/dextromethorphan/PSE 2 mg-10 mg-30 mg oral tablet, chewable:
2 tablets orally every 4 to 6 hours not to exceed 4 doses in 24 hours.

Usual Pediatric Dose for Cough and Nasal Congestion:

chlorpheniramine/dextromethorphan/PSE 2 mg-15 mg-15 mg/5 mL oral liquid:
12 yrs or older: 10 mL orally four times daily
6 yrs to 11 yrs: 5 mL orally four times daily
2 yrs to 5 yrs: 2.5 mL orally four times daily

chlorpheniramine/dextromethorphan/PSE 4 mg-30 mg-30 mg/5 mL oral suspension, extended release or
chlorpheniramine/dextromethorphan/PSE 6 mg-30 mg-30 mg/5 mL oral suspension, extended release or
chlorpheniramine/dextromethorphan/PSE 5 mg-25 mg-75 mg/5 mL oral suspension, extended release:
12 yrs or older: 5 to 10 mL orally every 12 hours
6 yrs to 11 yrs: 2.5 to 5 mL orally every 12 hours
2 yrs to 5 yrs: 2.5 mL orally every 12 hours

chlorpheniramine/dextromethorphan/PSE 0.8 mg-3 mg-9 mg/mL oral liquid:
25 to 36 months: 1 mL orally 4 times a day. Do not exceed 4 doses in a 24 hour period.
13 to 24 months: 0.75 mL orally 4 times a day. Do not exceed 4 doses in a 24 hour period.
6 to 12 months: 0.5 mL orally 4 times a day. Do not exceed 4 doses in a 24 hour period.

chlorpheniramine/dextromethorphan/PSE 2 mg-10 mg-30 mg oral tablet, chewable:
6 yrs to 11 yrs: 1 tablet orally every 4 to 6 hours not to exceed 4 doses in 24 hours.
12 yrs or older: 2 tablets orally every 4 to 6 hours not to exceed 4 doses in 24 hours.