Brompheniramine maleate and Pseudoephedrine hydrochloride

Brompheniramine maleate and Pseudoephedrine 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: Deepika Beereddy, MBBS [2]

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Overview

Brompheniramine maleate and Pseudoephedrine hydrochloride is an anti-allergic agent with vasoconstrictor agent that is FDA approved for the treatment of nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis, and symptoms due to hay fever (allergic rhinitis). Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• temporarily restores freer breathing through the nose

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Chlorpheniramine maleate, Phenylephrine hydrochloride and Dextromethorphan hydrobromide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorpheniramine maleate, Phenylephrine hydrochloride and Dextromethorphan hydrobromide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Chlorpheniramine maleate, Phenylephrine hydrochloride and Dextromethorphan hydrobromide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorpheniramine maleate, Phenylephrine hydrochloride and Dextromethorphan hydrobromide in pediatric patients.

Contraindications

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Contraindications in the drug label.

Warnings

• Do not use in a child under 6 years of age
• Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

• Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate gland
• breathing problem such as emphysema or chronic bronchitis

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

• When using this product

• do not use more than directed
• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

• Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• symptoms do not improve within 7 days or are accompanied by fever

• 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 Brompheniramine maleate and Pseudoephedrine hydrochloride Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Brompheniramine maleate and Pseudoephedrine hydrochloride in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Brompheniramine maleate and Pseudoephedrine hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Brompheniramine maleate and Pseudoephedrine hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Brompheniramine maleate and Pseudoephedrine hydrochloride in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Brompheniramine maleate and Pseudoephedrine hydrochloride in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Brompheniramine maleate and Pseudoephedrine hydrochloride in geriatric settings.

Gender

There is no FDA guidance on the use of Brompheniramine maleate and Pseudoephedrine hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Brompheniramine maleate and Pseudoephedrine hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Brompheniramine maleate and Pseudoephedrine hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Brompheniramine maleate and Pseudoephedrine hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Brompheniramine maleate and Pseudoephedrine hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Brompheniramine maleate and Pseudoephedrine hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

• Do not take more than 4 doses in any 24-hour period

Monitoring

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Brompheniramine maleate and Pseudoephedrine hydrochloride and IV administrations.

Overdosage

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Mechanism of Action in the drug label.

Structure

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride Clinical Studies in the drug label.

How Supplied

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride How Supplied in the drug label.

Storage

• Store at room temperature 20°-25°C (68°-77°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 Brompheniramine maleate and Pseudoephedrine hydrochloride Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Chlorpheniramine maleate, Phenylephrine hydrochloride and Dextromethorphan hydrobromide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

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Look-Alike Drug Names

There is limited information regarding Brompheniramine maleate and Pseudoephedrine hydrochloride 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.