Other
(Adults and children 2 years and older)
Cromolyn Sodium Spray, Metered
FDA Label NDC 57782-397
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bausch & Lomb Incorporated for the product Cromolyn Sodium (NDC 57782-397). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (per spray), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (Per Spray)
Cromolyn sodium 5.2 mg
Purpose
Nasal allergy symptom controller
Uses
to prevent and relieve nasal symptoms of hay fever and other nasal allergies:
▪ runny/itchy nose▪ sneezing▪ allergic stuffy nose
Warnings
For external use only
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
▪ see package insert on how to use pump▪ parent or care provider must supervise the use of this product by young children▪ adults and children 2 years and older:▪ spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day.▪ use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust)▪ to prevent nasal allergy symptoms, use before contact with the cause of your allergies. For best results, start using up to one week before contact.▪ if desired, you can use this product with other medicines, including other allergy medicines.
▪ children under 2 years: Do not use unless directed by a doctor.
Other Information
▪ store between 20-25°C (68-77°F)▪ protect from light▪ keep carton and package insert. They contain important instructions.▪ see bottom panel for lot number and expiration date
Inactive Ingredients
benzalkonium chloride, edetate disodium, purified water
Questions Or Comments?
Call toll-free 1-800-323-0000
Package/Label Principal Display Panel
Carton (Image 01)
HealthGuard
NDC 57782-397-26
Cromolyn
Sodium Nasal
Solution, USP
NASAL SPRAY
Nasal Allergy Symptom Controller
For intranasal use only.
Prevents and Relieves
Nasal Allergy Symptoms:
▪ runny/itchy nose▪ sneezing▪ allergic stuffy nose
Original Prescription Strength
Safe For Ages 2+
200 Metered Sprays
Each spray delivers 5.2 mg cromolyn sodium
0.88 FL OZ (26 mL)
* Please review the disclaimer below.
