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Cromolyn Sodium by Major Pharmaceuticals

Dosage form: spray, metered
Ingredients: CROMOLYN SODIUM 5.2mg in 1mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-5532

Cromolyn Sodium Nasal Solution USP
 NASAL SPRAY

(Adults and children 2 years and older)

Drug Facts

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?

Serious side effects associated with use of this product may be reported to: 1-800-323-0000

Before using any medication read all label directions. Keep carton and packaging insert. They contain important information.

Cromolyn Sodium Nasal Solution is convenient and easy to administer using the metered spray pump. See package insert for spray pump directions.

USE ONLY IF BODY SEAL IMPRINTED WITH "Protective Seal" AND YELLOW IS INTACT.

Distributed by:

MAJOR PHARMACEUTICALS

31778 Enterprise Drive,

Livonia, MI 48150  USA

Re-Order No. 248634

©Major Pharmaceuticals

M-115 Rev 10-10

Package/Label Principal Display Panel

MAJOR®

NDC 0904-5532-67

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5532
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CROMOLYN SODIUM (CROMOLYN) CROMOLYN SODIUM5.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:0904-5532-671 BOTTLE in 1 CARTON
126 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07570207/03/2001
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
Bausch & Lomb Incorporated079587625MANUFACTURE(0904-5532)

Revised: 09/2013
 
Major Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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