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Cromolyn Nasal Spray

Package insert / prescribing information
Generic name: cromolyn sodium
Dosage form: nasal spray, metered
Drug class: Nasal antihistamines and decongestants

Medically reviewed by Drugs.com. Last updated on Jun 1, 2021.

(Adults and children 2 years and older)

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

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 (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

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)

CROMOLYN SODIUM
cromolyn sodium spray, metered
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57782-397
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CROMOLYN SODIUM (CROMOLYN) CROMOLYN SODIUM 5.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
WATER
Packaging
# Item Code Package Description
1 NDC:57782-397-26 1 BOTTLE in 1 CARTON
1 26 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075702 07/03/2001
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies, Inc. 245141858 MANUFACTURE(57782-397)
Bausch & Lomb Incorporated