Codar AR

Codar AR is part of the drug classes:

• Substituted alkylamines

• Opium alkaloids and derivatives

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

Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

Chlorpheniramine and codeine is a combination medicine used to treat runny nose, sneezing, itching, watery eyes, and cough caused by allergies, the common cold, or the flu.

Chlorpheniramine and codeine will not treat a cough that is caused by smoking, asthma, or emphysema.

Chlorpheniramine and codeine may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to chlorpheniramine or codeine.

Do not use this medicine if you have used 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, tranylcypromine, and others.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Ask a doctor before giving this medicine to a child younger than 12 years old.

Medicines that contain codeine should not be used in anyone under 18 who recently had surgery to remove the tonsils or adenoids.

To make sure chlorpheniramine and codeine is safe for you, tell your doctor if you have ever had:

• asthma or other breathing problems;

• a head injury or brain tumor;

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

• enlarged prostate, urination problems;

• diabetes;

• liver or kidney disease;

• a thyroid disorder; or

• alcoholism or drug addiction.

If you use codeine 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.

Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby. Chlorpheniramine may slow breast milk production.

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

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

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

Stop using chlorpheniramine and codeine and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing;

• a slow heart rate or weak pulse;

• pounding heartbeats or fluttering in your chest;

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

• painful or difficult urination;

• tremor, uncontrolled muscle movements; or

• confusion, ringing in your ears.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects may include:

• dizziness, drowsiness;

• general ill feeling;

• mood changes, feeling agitated or irritable;

• headache, feeling light-headed;

• feeling restless, nervous, or excited;

• sleep problems (insomnia);

• constipation;

• nausea, vomiting, stomach pain, bloating;

• blurred vision, double vision; or

• dry mouth, nose, or throat.

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

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling nervous and excitable.
• Not able to sleep.
• Hard stools (constipation).
• Dizziness.
• Upset stomach or throwing up.
• Sweating a lot.
• Feeling tired or weak.
• Headache.
• Belly pain.
• Bloating.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to chlorpheniramine / codeine: oral suspension extended release

Along with its needed effects, chlorpheniramine / codeine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking chlorpheniramine / codeine:

• Acid or sour stomach
• anxiety
• belching
• bloating
• blurred or loss of vision
• chills
• cold clammy skin
• cold sweats
• confusion
• dark colored urine
• depression
• diarrhea
• difficult or painful urination
• disturbed color perception
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• dryness or spasm of the throat
• feeling of constant movement of self or surroundings
• fever
• halos around lights
• headache
• heartburn
• increased hunger
• indigestion
• irregular, fast or slow, or shallow breathing
• loss of appetite
• nausea
• nervousness
• night blindness
• nightmares
• overbright appearance of lights
• pain in the stomach, side, or abdomen, possibly radiating to the back
• pain or discomfort in the chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• pressure in the stomach
• pounding in the ears
• seizures
• sensation of spinning
• shakiness
• sleepiness or unusual drowsiness
• slow, fast, or irregular heartbeat
• slurred speech
• stomach discomfort, upset, or pain
• sweating
• tunnel vision
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Some side effects of chlorpheniramine / codeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Anxiety
• blistering, crusting, or irritation of the skin
• continuing ringing or buzzing or other unexplained noise in the ears
• cracked, dry, scaly skin
• dry mouth
• early menstrual periods
• face is warm or hot to touch
• false or unusual sense of well-being
• general feeling of discomfort or illness
• hearing loss
• hiccups
• increased appetite
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• irritability
• lack or loss of strength
• redness of the face
• restlessness
• skin rash, itching, redness, hives, swelling
• swelling of the breasts or breast soreness in both females and males
• trouble sleeping
• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• watering of eyes