Monday, September 26, 2016

Cromolyn Nasal Spray





Dosage Form: nasal spray, metered
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 TypeHUMAN OTC DRUGNDC Product Code (Source)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 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
157782-397-261 BOTTLE In 1 CARTONcontains a BOTTLE
126 mL In 1 BOTTLEThis package is contained within the CARTON (57782-397-26)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07570207/03/2001


Labeler - Bausch & Lomb Incorporated (196603781)









Establishment
NameAddressID/FEIOperations
Bausch & Lomb Incorporated807927397MANUFACTURE









Establishment
NameAddressID/FEIOperations
Cambrex Profarmaco Milano338332254MANUFACTURE









Establishment
NameAddressID/FEIOperations
Aventis Pharma Manufacturing Pte LTD.595299306MANUFACTURE
Revised: 07/2010Bausch & Lomb Incorporated




More Cromolyn Nasal Spray resources


  • Cromolyn Nasal Spray Use in Pregnancy & Breastfeeding
  • Cromolyn Nasal Spray Support Group
  • 0 Reviews for Cromolyn Nasal - Add your own review/rating


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