Cromolyn (nasal)

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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
Cromolyn (nasal) is a mast cell stabilizer that is FDA approved for the treatment of nasal symptoms due to hay fever and nasal allergies.   Common adverse reactions include stinging, nosebleeds, and sores in the nose.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- To prevent and relieve nasal symptoms of hay fever and other nasal allergies:
- Runny/itchy nose - sneezing - allergic stuffy nose

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cromolyn (nasal) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label Non-Guideline-Supported Use of Cromolyn (nasal) in adult patients.

# Pediatric Indications and Dosage

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

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cromolyn (nasal) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Cromolyn (nasal) in pediatric patients.

# Contraindications
There is limited information regarding Contraindications of Cromolyn (nasal) in pediatric patients.

# Warnings
Do not use
- If you are allergic to any of the ingredients
Ask a doctor before use if you have
- Fever
- Discolored nasal discharge
- Sinus pain
- Wheezing
When using this product
- It may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks.
- Brief stinging or sneezing may occur right after use
- Do not use it to treat sinus infection, asthma, or cold symptoms
- Do not share this bottle with anyone else as this may spread germs
Stop use and ask a doctor if
- Shortness of breath, wheezing, or chest tightness occurs
- Hives or swelling of the mouth or throat occurs
- Your symptoms worsen
- You have new symptoms
- Your symptoms do not begin to improve within two weeks
- You need to use for more than 12 weeks
If pregnant or breast-feeding
- Ask a health professional before use.
Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Cromolyn (nasal) in the drug label.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Cromolyn (nasal) in the drug label.

# Drug Interactions
There is limited information regarding Drug Interactions of Cromolyn (nasal) in the drug label.

# Use in Specific Populations

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

### Labor and Delivery
There is no FDA guidance on use of Cromolyn (nasal) during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Cromolyn (nasal) with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Cromolyn (nasal) with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Cromolyn (nasal) with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Cromolyn (nasal) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Cromolyn (nasal) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Cromolyn (nasal) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Cromolyn (nasal) in patients with hepatic impairment.

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

### Immunocompromised Patients
There is no FDA guidance one the use of Cromolyn (nasal) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Nasal

### Monitoring
There is limited information regarding Monitoring of Cromolyn (nasal) in the drug label

# IV Compatibility
There is limited information regarding IV Compatibility of Cromolyn (nasal) in the drug label.

# Overdosage
There is limited information regarding Chronic Overdose of Cromolyn (nasal) in the drug label.

# Pharmacology

## Mechanism of Action
There is limited information regarding Mechanism of action of Cromolyn (nasal) in the drug label.

## Structure
There is limited information regarding Structure of Cromolyn (nasal) in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Cromolyn (nasal) in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Cromolyn (nasal) in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Cromolyn (nasal) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Cromolyn (nasal) in the drug label.

# How Supplied
There is limited information regarding Cromolyn (nasal) How Supplied in the drug label.

## Storage
There is limited information regarding Cromolyn (nasal) Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Cromolyn (nasal) in the drug label.

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

# Brand Names
- NASALCROM

# Look-Alike Drug Names
There is limited information regarding Cromolyn (nasal) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price