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

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(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

Cromolyn Sodium Nasal Solution USP  (Carton, 26 mL - Bausch & Lomb / HealthGuard)

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:57782-397
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:57782-397-261 in 1 CARTON
126 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07570207/03/2001
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated807927397MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Cambrex Profarmaco Milano338332254MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Aventis Pharma Manufacturing Pte LTD.595299306MANUFACTURE

Revised: 07/2010
 
Bausch & Lomb Incorporated