DroTuss-CP

Drotuss CP is part of the drug classes:

• Substituted alkylamines

• Opium alkaloids and derivatives

• Adrenergic and dopaminergic agents

• Sympathomimetics

• Sympathomimetics excl. antiglaucoma preparations

• Sympathomimetics used as decongestants

• Sympathomimetics, combinations excl. corticosteroids

• Sympathomimetics, plain

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is a narcotic cough medicine.

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

Chlorpheniramine, hydrocodone, and phenylephrine is a combination medicine used to treat runny or stuffy nose, sinus congestion, and cough caused by the common cold or flu.

Chlorpheniramine, hydrocodone, and phenylephrine may also be used for purposes not listed in this medication guide.

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, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use chlorpheniramine, hydrocodone, and phenylephrine if you are allergic to it, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

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

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

• diarrhea, inflammatory bowel disease;

• a colostomy or ileostomy;

• liver or kidney disease;

• heart disease;

• glaucoma;

• bladder obstruction or other urination problems;

• a head injury or brain tumor;

• asthma, COPD, sleep apnea, or other breathing disorder;

• a thyroid disorder;

• pheochromocytoma (tumor of the adrenal gland);

• low blood pressure; or

• if you are dehydrated.

It is not known whether this medicine will harm an unborn baby. If you use hydrocodone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Chlorpheniramine, hydrocodone, and phenylephrine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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

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

• pounding heartbeats or fluttering in your chest;

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

• severe anxiety, confusion, fear;

• painful or difficult urination;

• little or no urinating; or

• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

• dizziness, drowsiness;

• mood changes;

• blurred vision; or

• nausea, vomiting.

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.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking chlorpheniramine, hydrocodone, and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with chlorpheniramine, hydrocodone, and phenylephrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.