CROMOLYN SODIUM spray, metered

Cromolyn Sodium by

Drug Labeling and Warnings

Cromolyn Sodium by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

(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)

INGREDIENTS AND APPEARANCE

CROMOLYN SODIUM 
cromolyn sodium spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5532
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W)	CROMOLYN SODIUM	5.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5532-67	1 in 1 CARTON	07/03/2001
1		26 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	MANUFACTURE(0904-5532)