BP Allergy JR

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. 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 antihistamine medication to make a child sleepy.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store at room temperature away from moisture and heat.

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

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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

Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and phenylephrine 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 decongestant.

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:

• chest pain, rapid pulse, fast or uneven heart rate;

• confusion, hallucinations, severe nervousness;

• tremor, seizure (convulsions);

• little or no urinating;

• easy bruising or bleeding, unusual weakness; or

• dangerously high blood pressure (severe headache, buzzing in your ears, anxiety, shortness of breath).

Common side effects may include:

• dizziness, drowsiness, blurred vision;

• dry nose or mouth;

• nausea, stomach pain, constipation, loss of appetite;

• problems with memory or concentration; or

• feeling restless or excited (especially in children).

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Applies to chlorpheniramine / phenylephrine: oral capsule extended release, oral drops, oral elixir, oral liquid, oral suspension, oral suspension extended release, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

General

General side effects including drowsiness, lassitude, giddiness, and increased irritability or excitement have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea and dryness of mouth have been reported.[Ref]

Cardiovascular

Cardiovascular side effects including palpitations and flushing have been reported.[Ref]

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