Cetirizine hydrochloride

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

# Overview
Cetirizine hydrochloride is an antihistamine that is FDA approved for the treatment of of symptoms due to hay fever or other upper respiratory allergies such as runny nose, sneezing, itchy watery eyes.   Common adverse reactions include xerostomia, asthenia, headache,  sedated, somnolence, fatigue, oculogyric crisis.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

# Indications
- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- Runny nose
- Sneezing
- Itching of the nose or throat
- Itchy, watery eyes

# Dosage
Adults
- One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
Adults 65 years and over
- Ask a doctor
Consumers with liver or kidney disease
- Ask a doctor

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cetirizine hydrochloride in adult patients.

### NonGuideline-Supported Use

# Indications
- Perennial allergic rhinitis
- Seasonal allergic rhinitis
- Urticaria, chronic

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

# Indications
- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- Runny nose
- Sneezing
- Itchy, watery eyes

# Dosing
Children 6 years and over
- One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
Children under 6 years of age
- Ask a doctor

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cetirizine hydrochloride in pediatric patients.

### NonGuideline-Supported Use

# Indications
- Perennial allergic rhinitis
- Seasonal allergic rhinitis
- Urticaria, chronic

# Contraindications
There is limited information regarding Cetirizine hydrochloride Contraindications in the drug label.

# Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using this product
- Drowsiness may occur
- Avoid alcoholic drinks
- Alcohol, sedatives, and tranquilizers may increase drowsiness
- Be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding:
- If breast feeding, not recommended
- If pregnant, ask a health professional before use
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Cetirizine hydrochloride Clinical Trials Experience in the drug label.

## Postmarketing Experience
- Gastrointestinal: xerostomia
- Neurologic: asthenia, headache,  sedated, somnolence
- Other: fatigue
- Ophthalmic: oculogyric crisis

# Drug Interactions
There is limited information regarding Cetirizine hydrochloride Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Cetirizine hydrochloride in women who are pregnant.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cetirizine hydrochloride in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Cetirizine hydrochloride during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Cetirizine hydrochloride in women who are nursing.

### Pediatric Use
There is no FDA guidance on the use of Cetirizine hydrochloride in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Cetirizine hydrochloride in geriatric settings.

### Gender
There is no FDA guidance on the use of Cetirizine hydrochloride with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Cetirizine hydrochloride with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Cetirizine hydrochloride in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Cetirizine hydrochloride in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cetirizine hydrochloride in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Cetirizine hydrochloride in patients who are immunocompromised.

# Administration and Monitoring

### Administration
Oral

### Monitoring
There is limited information regarding Cetirizine hydrochloride Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Cetirizine hydrochloride and IV administrations.

# Overdosage
There is limited information regarding Cetirizine hydrochloride overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action
There is limited information regarding Cetirizine hydrochloride Mechanism of Action in the drug label.

## Structure
There is limited information regarding Cetirizine hydrochloride Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Cetirizine hydrochloride Pharmacodynamics in the drug label.

## Pharmacokinetics
There is limited information regarding Cetirizine hydrochloride Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Cetirizine hydrochloride Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Cetirizine hydrochloride Clinical Studies in the drug label.

# How Supplied
There is limited information regarding Cetirizine hydrochloride How Supplied in the drug label.

## Storage
Store between 20 to 25C (68 to 77F)

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Cetirizine hydrochloride Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Cetirizine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
zyrtec

# Look-Alike Drug Names
There is limited information regarding Cetirizine hydrochloride Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price