Thonzylamine hydrochloride and chlophedianol hydrochloride
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 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
- 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
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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 ®[1]
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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