Dexbrompheniramine

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Dexbrompheniramine
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: Adeel Jamil, 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

Dexbrompheniramine is a antihistamine and alkylamine that is FDA approved for the treatment of rash, xerostomia, drowsiness, dizziness, nervousness and insomnia. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dexbrompheniramine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Dexbrompheniramine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dexbrompheniramine in pediatric patients.

Contraindications

There is limited information regarding Contraindications of Dexbrompheniramine in pediatric patients.

Warnings

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.=

When using this product
  • excitability may occur, especially in children
  • may cause drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • 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 overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Dexbrompheniramine in the drug label.

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Drug Interactions of Dexbrompheniramine in pediatric patients.

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 Dexbrompheniramine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dexbrompheniramine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dexbrompheniramine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Dexbrompheniramine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Dexbrompheniramine with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

There is no FDA guidance on the use of Dexbrompheniramine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dexbrompheniramine in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Dexbrompheniramine in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Chronic Overdose of Dexbrompheniramine in the drug label.

Pharmacology

There is limited information regarding Dexbrompheniramine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Dexbrompheniramine01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Dexbrompheniramine Storage in the drug label.

Images

Drug Images

No image.jpg

Drug Name:
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Drug Label Author:

This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-783-60


ALA-HIST IR 2 mg Tablets

Antihistamine

Each tablet contains: Dexbrompheniramine Maleate.........2 mg

60 Tablets

Usual Dosage: See product foldout for full prescribing information

Tamper evident by foil seal under cap. Do not

use if foil seal is broken or missing.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Store at controlled room temperature 15°-30°C (59°-86°F).

Manufactured for: Poly Pharmaceuticals Quitman, MS 39355

Rev. 02/12

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

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Dexbrompheniramine in the drug label.

Precautions with Alcohol

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

Brand Names

  • ®

Look-Alike Drug Names

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

Drug Shortage Status

Price

References

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