Chlorcyclizine

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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
Chlorcyclizine is a antihistamine that is FDA approved for the treatment of hay fever or other upper respiratory allergies.   Common adverse reactions include excitability, drowsiness.

# 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

### Directions
- Do not exceed recommended dosage.

## Off-Label Use and Dosage (Adult)

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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Chlorcyclizine in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

### Directions
- Do not exceed recommended dosage.

## Off-Label Use and Dosage (Pediatric)

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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Chlorcyclizine in pediatric patients.

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

# Warnings
- Do not exceed recommended dosage.
- Do not take this product unless directed by a doctor if you have
- Ask a doctor before use if you are taking sedatives or tranquilizers
- When using this product
- Use caution when driving a motor vehicle or operating machinery.
- If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

# Adverse Reactions

## Clinical Trials Experience
- excitability
- drowsiness

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Chlorcyclizine in the drug label.

# Drug Interactions

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- If pregnant or breast-feeding, ask a health professional before use.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chlorcyclizine in women who are pregnant.

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

### Nursing Mothers
- If pregnant or breast-feeding, ask a health professional before use.

### Pediatric Use
There is no FDA guidance on the use of Chlorcyclizine with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Chlorcyclizine with respect to geriatric patients.

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

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

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

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

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

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

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of Chlorcyclizine in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Chlorcyclizine in the drug label.

# Overdosage
There is limited information regarding Overdose of Chlorcyclizine in the drug label.

# Pharmacology

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

## Structure
- Chlorcyclizine HCl 25 mg
- Lake Blend Green, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Chlorcyclizine in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Chlorcyclizine in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Chlorcyclizine in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Chlorcyclizine in the drug label.

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

## Storage
There is limited information regarding Chlorcyclizine Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL - 30 TABLET CARTON
NDC 58407-025-30
AHISTTM
Antihistamine
Each tablet contains:
Chlorcyclizine HCl 25 mg
MAGNA
Pharmaceuticals, Inc.
Louisville, KY 40299
30 Tablets

### Ingredients and Appearance

# Patient Counseling Information

### QUESTIONS OR COMMENTS?
Call 1-888-206-5525
www.magnaweb.com

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

# Brand Names
- AHIST

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

# Drug Shortage Status

# Price