CROMOLYN SODIUM- cromolyn sodium spray, metered
Bausch & Lomb Incorporated

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Cromolyn Sodium Nasal Solution USP
NASAL SPRAY

(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

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.

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.

Inactive ingredients

benzalkonium chloride, edetate disodium, purified water

Questions?

call toll-free 1-800-323-0000

Package/Label Principal Display Panel

NDC 57782-397-26

HealthGuard

Cromolyn Sodium Nasal Solution USP

NASAL SPRAY

Nasal Allergy Symptom Controller

Prevents and Relieves Nasal Allergy Symptoms:
runny/itchy nose
sneezing
allergic stuffy nose

Without Drowsiness

Full Prescription Strength

Safe For Ages 2 Years & Older

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 LABEL	Item Code (Source)	NDC:57782-397
Route of Administration	NASAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CROMOLYN SODIUM (CROMOLYN)	CROMOLYN SODIUM	5.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
WATER

#	Item Code	Package Description
Packaging
1	NDC:57782-397-26	1 in 1 CARTON
1		26 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075702	07/03/2001

Labeler - Bausch & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		807927397	MANUFACTURE(57782-397)

Name	Address	ID/FEI	Business Operations
Establishment
Cambrex Profarmaco Milano Srl		438051401	API MANUFACTURE(57782-397)

Name	Address	ID/FEI	Business Operations
Establishment
Aventis Pharma Manufacturing Pte LTD.		595299306	API MANUFACTURE(57782-397)

Revised: 8/2013

Document Id: 1154c1a5-f86a-4fab-8845-795a8b85ccac

Set id: 379f4b59-6866-4b5c-9b1b-d8a35b741461

Version: 2

Effective Time: 20130821

Bausch & Lomb Incorporated

Cromolyn Sodium Nasal Solution USPNASAL SPRAY