Thonzylamine hydrochloride and chlophedianol hydrochloride: Difference between revisions

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|genericName=thonzylamine hydrochloride and chlophedianol hydrochloride
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|indication=symptoms due to common cold, [[hay fever]] and upper respiratory allergies
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|adverseReactions=[[drowsiness]], [[dizziness]], [[flushing]], [[headache]], [[nausea]], [[nervousness]], [[blurred vision]], and [[dry mouth]]/nose/throat may occur.
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|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Thonzylamine hydrochloride and chlophedianol hydrochloride in pediatric patients.
 
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* Content
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|fdaLIADPed===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
 
==Dosage==
 
* Children 2 to under 6 years of age: 2 mL every 6 hours not to exceed 8 mL in 24 hours, or as directed by a doctor
 
* Children under 2 years of age: consult a doctor
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* 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.
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|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=* POLY HIST PD ®<ref>{{Cite web | title =POLY HIST PD- thonzylamine hydrochloride and chlophedianol hydrochloride liquid| url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d219ff56-bf03-4a5f-9100-7c6d07c972dd }}</ref>
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[[Category:Drug]]

Latest revision as of 17:16, 20 August 2015

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]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
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 drowsiness, dizziness, flushing, headache, nausea, nervousness, blurred vision, and dry mouth/nose/throat may occur..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

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)

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

Dosage

  • Children 2 to under 6 years of age: 2 mL every 6 hours not to exceed 8 mL in 24 hours, or as directed by a doctor
  • Children under 2 years of age: consult a doctor

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
  • Use only with enclosed dropper
  • Do not use enclosed dropper for any other drug product

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 Mechanism Of Action of Thonzylamine hydrochloride and chlophedianol hydrochloride in the drug label.

Structure

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

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

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

Storage

  • Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).

Images

Drug Images

{{#ask: Page Name::Thonzylamine hydrochloride and chlophedianol hydrochloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

{{#ask: Label Page::Thonzylamine hydrochloride and chlophedianol hydrochloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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 ®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. "POLY HIST PD- thonzylamine hydrochloride and chlophedianol hydrochloride liquid".

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