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Name:Nasalcrom
Manufacturer:Blacksmith Brands, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


NasalCrom

NASALCROM - cromolyn sodium spray, metered 
Blacksmith Brands, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NasalCrom

NasalCrom

Drug Facts

Active ingredient (per spray)

Cromolyn sodium 5.2mg

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. (1-800-222-1222)

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.
  • do not use if imprinted plastic bottle wrap is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

benzalkonium chloride, edetate disodium, purified water

Questions or comments?

call 1-877-9-ALLERGY (1-877-925-5374)

Principal Display Panel

cromolyn sodium nasal solution USP
Nasal Spray
NasalCrom
NASAL ALLERGY SYMPTOM CONTROLLER
Presents and Relieves

Nasal Allergy Symptoms

runny/itchy nose

Without Drowsiness
Full Prescription Strength
Safe for Ages 2 Years & older
100 Metered Sprays
Each spray delivers
5.2 mg cromolyn sodium 0.44 FL AZ (13 mL)

Principal Display Panel
NasalCrom
Nasal Allergy Symptom Controller


NASALCROM 
cromolyn sodium spray, metered
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-199
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CROMOLYN SODIUM (CROMOLYN) CROMOLYN SODIUM 5.2 mg
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
EDETATE DISODIUM  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52183-199-14 1 BOTTLE, PUMP (1 BOTTLE) in 1 CARTON contains a BOTTLE, PUMP
1 100 SPRAY, METERED (100 SPRAY) in 1 BOTTLE, PUMP This package is contained within the CARTON (52183-199-14)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 10/29/2009

Labeler - Blacksmith Brands, Inc. (021411299)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Inc. 002207751 MANUFACTURE

Revised: 03/2010 Blacksmith Brands, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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