Dextromethorphan hydrobromide

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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
Dextromethorphan hydrobromide is an antitussive that is FDA approved for the treatment of cough.   Common adverse reactions include dizziness, somnolence, fatigue.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

# Indications
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

# Dosing
- Do not take more than 4 doses in any 24-hour period
- This adult product is not intended for use in children under 12 years of age
- Measure only with dosing cup provided
- Keep dosing cup with product
- tsp = teaspoon, mL = milliliter

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use

# Indications and Dosing
- Cough: 30 mg orally every 6 to 8 hours; max 120 mg/day

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

# Pediatric Indications and Dosage

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

## Off-Label Use and Dosage (Pediatric)

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

### NonGuideline-Supported Use

# Indications and Dosing
- Cough/cold products should not be used in children younger than 2 years due to the risk of serious and life-threatening effects; dextromethorphan is commonly used as a cough suppressant in combination over-the-counter cough and cold products.
- Cough: (12 years or older) 30 mg ORALLY every 6 to 8 hours; MAX 120 mg/day

# Contraindications
There is limited information regarding Dextromethorphan hydrobromide Contraindications in the drug label.

# Warnings
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
- Cough that occurs with too much phlegm (mucus)
- Cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
When using this product
- Do not use more than directed
Stop use and ask a doctor if
- Cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache that lasts. These could be signs of a serious condition.
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 (1-800-222-1222) right away.

# Adverse Reactions

## Clinical Trials Experience
Neurologic: Dizziness, Somnolence
Other: Fatigue

## Postmarketing Experience
There is limited information regarding Dextromethorphan hydrobromide Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Dextromethorphan hydrobromide Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Dextromethorphan hydrobromide in women who are pregnant.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dextromethorphan hydrobromide in women who are pregnant.

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

### Nursing Mothers
There is no FDA guidance on the use of Dextromethorphan hydrobromide in women who are nursing.

### Pediatric Use
There is no FDA guidance on the use of Dextromethorphan hydrobromide in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Dextromethorphan hydrobromide in geriatric settings.

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

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

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

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

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

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

# Administration and Monitoring

### Administration
Oral

### Monitoring
There is limited information regarding Dextromethorphan hydrobromide Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Dextromethorphan hydrobromide and IV administrations.

# Overdosage
There is limited information regarding Dextromethorphan hydrobromide overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

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

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

## Pharmacodynamics
There is limited information regarding Dextromethorphan hydrobromide Pharmacodynamics in the drug label.

## Pharmacokinetics
There is limited information regarding Dextromethorphan hydrobromide Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Dextromethorphan hydrobromide Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Dextromethorphan hydrobromide Clinical Studies in the drug label.

# How Supplied
There is limited information regarding Dextromethorphan hydrobromide How Supplied in the drug label.

## Storage
- Store at 20o-25oC (68o-77oF). Do not refrigerate.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Dextromethorphan hydrobromide Patient Counseling Information in the drug label.

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

# Brand Names
- Benylin
- Creomulsion
- Delsym.

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

# Drug Shortage Status

# Price