VaZol

• It is used to ease allergy signs.

• If you have an allergy to brompheniramine or any other part of VaZol (brompheniramine liquid).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have asthma.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are breast-feeding. Do not breast-feed while you take VaZol.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take VaZol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Shortness of breath.
• Change in balance.
• Change in eyesight.
• Mood changes.
• Hallucinations (seeing or hearing things that are not there).
• Very bad sore throat.
• Fever or chills.
• Trouble passing urine.
• Any unexplained bruising or bleeding.
• Very bad dizziness or passing out.
• Feeling very tired or weak.
• Feeling confused.
• Restlessness.
• Shakiness.
• Seizures.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Applies to brompheniramine: oral liquid, oral tablet chewable, oral tablet extended release 12 hour

Applies to brompheniramine: compounding powder, injectable solution, oral capsule, oral capsule extended release, oral liquid, oral suspension extended release, oral tablet, oral tablet chewable extended release, oral tablet extended release

Nervous system

Nervous system side effects have included central nervous system (CNS) depression, resulting in drowsiness and sedation in nearly 50% of patients treated. This effect has often been transient and ceased with continued use. Motor skills have be impaired and patients should be advised to avoid tasks which require attention. Patients should also avoid concomitant use with alcohol and other sedative-hypnotic drugs. Dyskinesias have rarely been reported following chronic use of brompheniramine (the active ingredient contained in VaZol) [Ref]

A few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of brompheniramine extended over a period of up to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms in these patients. Spasmodic torticollis has been reported in a child given brompheniramine over an eight month period.[Ref]

Gastrointestinal

Gastrointestinal side effects have include nausea, dry mouth and constipation.[Ref]

Cardiovascular

Cardiovascular effects of brompheniramine (the active ingredient contained in VaZol) have included hypotension, tachycardia, and palpitations.[Ref]

Ocular

Ocular side effects have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]

Genitourinary

Genitourinary side effects have included dysuria, urinary hesitancy, decrease in urine flow, and, in rare cases, acute urinary retention.[Ref]

Hematologic

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

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