Narcotic Cough/Cold Preparations Oral capsule, extended-release

What is this medicine?

CHLORPHENIRAMINE; HYDROCODONE; PSEUDOEPHEDRINE (klor fen IR a meen; hye droe KOE done; soo doe e FED rin) is a combination of an antihistamine, cough suppressant, and decongestant. It is used to treat cough and congestion, colds, and bronchitis. It is also used to treat the symptoms of allergy. This medicine will not treat an infection.

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 years old for selected conditions, precautions do apply. This medicine is not approved for use in children less than 6 years old.

Patients over 60 years old may have a stronger reaction and need a smaller dose.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion

• difficulty passing urine

• fast, irregular heartbeat

• fear, anxiety, restless, tremor

• feeling faint or lightheaded

• hallucinations

• high or low blood pressure

• numbness or tingling in the hands or feet

• seizures

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• drowsy, tired

• dry mouth, nose, throat

• headache

• loss of appetite

• more sensitive to sunlight

• nausea, vomiting

• passing urine more often

• trouble sleeping

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

• alcohol

• barbiturates like phenobarbital

• certain heart medicines like metoprolol and digoxin

• medicines for blood pressure

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• medicines for stomach problems like hyoscyamine

• methyldopa

• muscle relaxers

• naltrexone

• narcotic medicines for pain

• other medicines for cold, cough, or allergy

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• asthma

• diabetes

• drug abuse or addiction

• glaucoma

• heart disease

• high blood pressure

• if you have taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days

• recent head trauma

• stomach ulcer

• trouble passing urine

• an unusual or allergic reaction to chlorpheniramine, hydrocodone or codeine, pseudoephedrine, other medicines, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

You may develop tolerance to this medicine if you take it for a long time. Tolerance means that you will get less cough relief with time. Tell your doctor or health care professional if your symptoms do not improve or if they get worse.

If you have been taking this medicine for a long time, do not suddenly stop taking it because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a nonmedical reason. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

The medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.