Dexbrompheniramine
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
- 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
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
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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 {{#ask: Label Page::Dexbrompheniramine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.
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