Active ingredient

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 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 any one 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 in each nostril. Repeat 3-4 times a day (every 4 to 6 hours). If needed, may be used up to 6 times a day. Use every day when in contact with your allergies (pollen, molds, pets and dust). To prevent allergy symptoms, use before contact with the cause of your allergies. For best results, start using one week before contact. If desired you can use this product with other medicines, including 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 information

Inactive ingredients

benzalkonium chloride, edetate disodium, purified water

Questions?

Serious side effects associated with the use of this product may be reported to:

1-800-323-0000.

Principle Display Panel

CROMOLYN SODIUM
cromolyn sodium spray, metered

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0904-5532 (0904-5532)
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
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0904-5532-67	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		26 mL In 1 BOTTLE	This package is contained within the CARTON (0904-5532-67)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075702	03/07/2008

Labeler - Major Pharmaceuticals (191427277)

Revised: 01/2010Major Pharmaceuticals