Trigofen DM Drops

Do not use chlorpheniramine, dextromethorphan, and phenylephrine 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 phenylephrine 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.

Drinking alcohol can increase certain side effects of chlorpheniramine, dextromethorphan, and phenylephrine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines and cough suppressants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or cough suppressant.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine and phenylephrine can decrease sweating and you may be more prone to heat stroke.

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:

• severe anxiety or restless feeling, hallucinations, tremor, seizure (convulsions);

• fast or pounding heartbeats;

• painful or difficult urination, little or no urinating;

• pale skin, weakness; or

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

Common side effects may include:

• nausea, vomiting, diarrhea, heartburn, loss of appetite;

• dry mouth;

• increased urination;

• dizziness, drowsiness, double vision, mild headache;

• sleep problems (insomnia); or

• nervousness.

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.

Tell your doctor about all medicines you use, 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 this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking chlorpheniramine, dextromethorphan, and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Applies to chlorpheniramine / dextromethorphan / phenylephrine: oral drops, oral liquid, oral syrup, oral tablet effervescent, oral tablet extended release

Gastrointestinal

Gastrointestinal side effects have included vomiting, diarrhea, dry mouth, nausea, anorexia, heartburn, and GI disturbance.[Ref]

Nervous system

Nervous system side effects have included sedation, drowsiness, dizziness, nervousness, headache, convulsions, central nervous system stimulation, hallucinations, tremors, and insomnia.[Ref]

Cardiovascular

Cardiovascular side effects have included cardiac arrhythmias, increased heart rate, and increased blood pressure.[Ref]

General

General side effects have included weakness and pallor.[Ref]

Genitourinary

Genitourinary side effects have included polyuria and dysuria. Urinary retention may occur in patients with prostatic hypertrophy.[Ref]

Respiratory

Respiratory side effects have included respiratory difficulties.[Ref]

Ocular

Ocular side effects have included diplopia.[Ref]

Some side effects of Trigofen DM Drops may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.