Zyrtec

DRUG DESCRIPTION

Cetirizine hydrochloride, the active component of ZYRTEC® (cetirizine) tablets and syrup,
is an orally active and selective H₁-receptor antagonist. The chemical
name is (±) - [2- [4- [ (4-chlorophenyl)phenylmethyl] -1- piperazinyl]
ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound
with an empirical formula of C₂₁H₂₅C_lN₂O₃•2HCl.
The molecular weight is 461.82 and the chemical structure is shown below:

Cetirizine hydrochloride is a white, crystalline powder and is water soluble. ZYRTEC (cetirizine) tablets are formulated as white, film-coated, rounded-off rectangular shaped tablets for oral administration and are available in 5 and 10 mg strengths. Inactive ingredients are: lactose monohydrate; microcrystalline cellulose; colloidal silicon dioxide; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; and polyethylene glycol.

ZYRTEC (cetirizine) chewable tablets are formulated as purple round tablets for oral administration and are available in 5 and 10 mg strengths. Inactive ingredients of the chewable tablets are: acesulfame potassium; artificial grape flavor; betadex, NF; blue dye; colloidal silicon dioxide; lactose monohydrate; magnesium stearate; mannitol; microcrystalline cellulose; natural flavor; red dye (carmine).

ZYRTEC (cetirizine) syrup is a colorless to slightly yellow syrup containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the syrup are: banana flavor; glacial acetic acid; glycerin; grape flavor; methylparaben; propylene glycol; propylparaben; sodium acetate; sugar syrup; and water.

What are the possible side effects of cetirizine (All Day Allergy, All Day Allergy Children's, Indoor/Outdoor Allergy Relief, Zyrtec, Zyrtec Hives)?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;


• weakness, tremors (uncontrolled shaking), or sleep problems (insomnia);


• severe restless feeling, hyperactivity;

...

Read All Potential Side Effects and See Pictures of Zyrtec »

What are the precautions when taking cetirizine (Zyrtec)?

Before taking cetirizine, tell your doctor or pharmacist if you are allergic to it; or to hydroxyzine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history. Do not self-treat with this medication without consulting your doctor first if you have certain medical conditions such as: kidney disease, liver disease.

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have hives and your doctor has prescribed cetirizine, or if...

Read All Potential Precautions of Zyrtec »

Zyrtec Consumer (continued)

SIDE EFFECTS: Drowsiness, tiredness, and dry mouth may occur. In children, stomach pain and vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has prescribed this medication, he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking cetirizine, tell your doctor or pharmacist if you are allergic to it; or to hydroxyzine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history. Do not self-treat with this medication without consulting your doctor first if you have certain medical conditions such as: kidney disease, liver disease.

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have hives and your doctor has prescribed cetirizine, or if you are considering using this drug to treat your own hives, tell your doctor immediately if you have any of these other symptoms because they may be signs of a more serious condition: hives that are an unusual color, hives that look bruised or blistered, hives that do not itch.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be at greater risk for side effects (e.g., drowsiness) while using this drug.

During pregnancy, this medication should be used only when clearly needed and as directed by your doctor. Discuss the risks and benefits with your doctor before taking this drug.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Zyrtec Patient Information Including Side Effects

Brand Names: All Day Allergy, All Day Allergy Children's, Indoor/Outdoor Allergy Relief, Zyrtec, Zyrtec Hives

Generic Name: cetirizine (Pronunciation: se TIR a zeen)

• What is cetirizine (Zyrtec)?


• What are the possible side effects of cetirizine (Zyrtec)?


• What is the most important information I should know about cetirizine (Zyrtec)?


• What should I discuss with my healthcare provider before taking cetirizine (Zyrtec)?


• How should I take cetirizine (Zyrtec)?


• What happens if I miss a dose (Zyrtec)?


• What happens if I overdose (Zyrtec)?


• What should I avoid while taking cetirizine (Zyrtec)?


• What other drugs will affect cetirizine (Zyrtec)?


• Where can I get more information?

What is cetirizine (Zyrtec)?

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

Cetirizine is used to treat cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose.

Cetirizine is also used to treat itching and swelling caused by chronic urticaria (hives).

Cetirizine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of cetirizine (Zyrtec)?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;


• weakness, tremors (uncontrolled shaking), or sleep problems (insomnia);


• severe restless feeling, hyperactivity;


• confusion;


• problems with vision; or


• urinating less than usual or not at all.

Less serious side effects may include:

• dizziness, drowsiness;


• tired feeling;


• dry mouth;


• sore throat, cough;


• nausea, constipation; or


• headache.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about cetirizine (Zyrtec)?

Cetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of cetirizine.

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by cetirizine.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

Related Drug Centers

• Zyrtec