Thonzylamine hydrochloride and chlophedianol hydrochloride

Thonzylamine hydrochloride and chlophedianol hydrochloride
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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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

Thonzylamine hydrochloride and chlophedianol hydrochloride is an antihistamine that is FDA approved for the treatment of symptoms due to common cold, hay fever and upper respiratory allergies. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• Cough due to minor throat and bronchial irritation
• Calms the cough control center and relieves coughing
• Runny nose
• Sneezing
• Itching of the nose and throat
• Itchy, watery eyes

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Thonzylamine hydrochloride and chlophedianol hydrochloride in adult patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Thonzylamine hydrochloride and chlophedianol hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• There is limited information regarding FDA-Labeled Use of Thonzylamine hydrochloride and chlophedianol hydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Thonzylamine hydrochloride and chlophedianol hydrochloride in pediatric patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Thonzylamine hydrochloride and chlophedianol hydrochloride in pediatric patients.

Contraindications

There is limited information regarding Thonzylamine hydrochloride and chlophedianol hydrochloride Contraindications in the drug label.

Warnings

Ask a doctor before use if

• A child has

• A cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
• A cough that occurs with too much phlegm (mucus)
• A breathing problem such as emphysema or chronic bronchitis

glaucoma

Ask a doctor or pharmacist before use if

• A child is taking sedatives or tranquilizers.

When using this product

• Excitability may occur, especially in children
• May cause marked drowsiness
• Sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if

• Cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

new symptoms occur

Keep out of reach of children.

• In case of overdose, get medical help or contact a Poison Control Center immediately.

Adverse Reactions

Clinical Trials Experience

• There is limited information regarding Clinical Trial Experience of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

Drug Interactions

There is limited information regarding Thonzylamine hydrochloride and chlophedianol hydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Thonzylamine hydrochloride and chlophedianol hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Thonzylamine hydrochloride and chlophedianol hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Thonzylamine hydrochloride and chlophedianol hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Thonzylamine hydrochloride and chlophedianol hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Thonzylamine hydrochloride and chlophedianol hydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Thonzylamine hydrochloride and chlophedianol hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Thonzylamine hydrochloride and chlophedianol hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Thonzylamine hydrochloride and chlophedianol hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Thonzylamine hydrochloride and chlophedianol hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Thonzylamine hydrochloride and chlophedianol hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Thonzylamine hydrochloride and chlophedianol hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Monitoring of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

Pharmacology

There is limited information regarding Thonzylamine hydrochloride and chlophedianol hydrochloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Thonzylamine hydrochloride and chlophedianol hydrochloride Mechanism of Action in the drug label.

Structure

File:Thonzylamine hydrochloride and chlophedianol hydrochloride01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Thonzylamine hydrochloride and chlophedianol hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

Precautions with Alcohol

• Alcohol-Thonzylamine hydrochloride and chlophedianol hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• POLY HIST PD ®

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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