Brompheniramine and phenylephrine

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, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use this medicine if you are allergic to brompheniramine or phenylephrine.

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

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

• kidney or liver disease;

• high blood pressure, heart disease;

• an enlarged prostate or urination problems;

• glaucoma;

• epilepsy or other seizure disorder;

• pheochromocytoma (an adrenal gland tumor);

• overactive thyroid; or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether brompheniramine and phenylephrine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

It is not known whether brompheniramine and phenylephrine passes into breast milk or if it could harm a nursing baby. Antihistamines and decongestants may slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

Artificially sweetened liquid medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

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

Drinking alcohol with this medicine can cause side effects.

Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Many combination medicines contain brompheniramine or phenylephrine. Taking certain products together can cause you to get too much of this medicine. 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, fast or uneven heart rate;

• little or no urinating;

• confusion, severe nervousness; or

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

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

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.

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.
• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.

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 brompheniramine / phenylephrine: oral capsule extended release, oral elixir, oral liquid, oral suspension extended release, oral tablet, oral tablet chewable, oral tablet chewable extended release, oral tablet extended release

Gastrointestinal

Gastrointestinal side effects have included nausea, epigastric distress, anorexia, vomiting, diarrhea, and constipation.[Ref]

Cardiovascular

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

Genitourinary

Genitourinary side effects have included urinary frequency, difficult urination, urinary retention, and early menses.[Ref]

Respiratory

Respiratory side effects have included thickening of bronchial secretions, tightness of chest, wheezing, and nasal stuffiness.[Ref]

Hematologic

Hematologic side effects have included hemolytic anemia, thrombocytopenia and agranulocytosis.[Ref]

Nervous system

Nervous system side effects have included headache, sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, vertigo, hysteria, neuritis and convulsions.[Ref]

Ocular

Ocular side effects have included blurred vision and diplopia.[Ref]

Dermatologic

Dermatologic side effects have included photosensitivity, excessive perspiration, and flushing.[Ref]

General

General side effects have included chills, and dryness of the mouth, nose and throat.[Ref]

Hypersensitivity

Hypersensitivity side effects have included urticaria, drug rash, and anaphylactic shock.[Ref]

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