Brompheniramine

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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
Brompheniramine is an anticholinergic that is FDA approved for the treatment of hay fever (allergic rhinitis) or upper respiratory allergies.   Common adverse reactions include hypersensitivity, drowsiness.

# 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)

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Brompheniramine in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Brompheniramine in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Brompheniramine in pediatric patients.

# Contraindications
Hypersensitivity to any of the ingredients.

# 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.
- Overdose may cause hallucinations, convulsions, and death.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Brompheniramine in the drug label.

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

# Drug Interactions
There is limited information regarding Brompheniramine 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 Brompheniramine in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Brompheniramine during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Brompheniramine with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Brompheniramine with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Brompheniramine with respect to geriatric patients.

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

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

### Renal Impairment
There is no FDA guidance on the use of Brompheniramine in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Brompheniramine in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Brompheniramine in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Brompheniramine in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral.

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

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

# Overdosage
There is limited information regarding Chronic Overdose of Brompheniramine in the drug label.

# Pharmacology
There is limited information regarding Brompheniramine Pharmacology in the drug label.

## Mechanism of Action
There is limited information regarding Brompheniramine Mechanism of Action in the drug label.

## Structure
There is limited information regarding Brompheniramine Structure in the drug label.

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

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

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

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

# How Supplied
- Supplied in a tight, light-resistant container with a child-resistant cap.
- Contains color additives including FD&C Yellow No. 5 (tartrazine).
- Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed "Poly" bisect "783" on one side and plain on the other

## Storage
- Store at 15 - 30C (59 - 86F).

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information

## Directions for Use

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

# Brand Names
- ALA-HIST IR 

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

# Drug Shortage Status

# Price