Ed-Chlor Ped Jr

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

You should not use this medicine if you have narrow-angle glaucoma, a blockage in your stomach or intestines, an enlarged prostate, if you are unable to urinate, or if you are having an asthma attack.

You should not use chlorpheniramine if you are allergic to it, or if you have:

• narrow-angle glaucoma;

• a blockage in your stomach or intestines;

• an enlarged prostate;

• if you are unable to urinate; or

• if you are having an asthma attack.

Ask a doctor or pharmacist if it is safe for you to take chlorpheniramine if you have:

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

• liver or kidney disease;

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

• high blood pressure, heart disease, coronary artery disease, or recent heart attack;

• epilepsy or other seizure disorder;

• urination problems;

• pheochromocytoma (an adrenal gland tumor); or

• overactive thyroid.

FDA pregnancy category B. Chlorpheniramine is not expected to harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

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

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

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 chlorpheniramine and call your doctor at once if you have:

• fast or uneven heart rate;

• mood changes;

• tremor, seizure (convulsions);

• easy bruising or bleeding, unusual weakness;

• feeling short of breath; or

• little or no urinating.

Common side effects may include:

• dizziness, drowsiness;

• dry mouth, nose, or throat;

• constipation;

• blurred vision; or

• feeling nervous or restless.

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.

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: compounding powder, injectable solution, oral capsule extended release, oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

Nervous system

Central nervous system side effects have included depression resulting in drowsiness in 75% or more of treated patients. Dyskinesias have rarely been reported following chronic use of chlorpheniramine (the active ingredient contained in Ed Chlor Ped Jr.) [Ref]

Nearly all patients treated with chlorpheniramine experience drowsiness. This drowsiness may subside in some patients with extended use.

Few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of chlorpheniramine extended over a period of 3 to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dry mouth and constipation in up to one-third of treated patients.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension, tachycardia, and palpitations.[Ref]

Ocular

Ocular side effects of chlorpheniramine (the active ingredient contained in Ed Chlor Ped Jr.) may include blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]

Genitourinary

Genitourinary side effects have included dysuria, urinary hesitancy, and a decreased urine flow. In rare cases, the anticholinergic effect of chlorpheniramine (the active ingredient contained in Ed Chlor Ped Jr.) has precipitated acute urinary retention.[Ref]

Hematologic

Hematologic side effects have included bone marrow suppression, thrombocytopenia, and aplastic anemia.[Ref]

A fatal case of agranulocytosis has been reported in a patient taking chlorpheniramine, pseudoephedrine, acetaminophen, dextromethorphan, phenylpropanolamine, and aspirin. Chlorpheniramine was felt to be the cause.[Ref]

Some side effects of Ed Chlor Ped Jr. may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.