Cromolyn Sodium Nasal Solution Usp

Cromolyn Sodium Nasal Solution Usp
SPL v1
SPL
SPL Set ID 74a45491-238b-48bf-8b14-569e1df61fef
Route
NASAL
Published
Effective Date 2010-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cromolyn (5.2 mg)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2001-07-03

Description

Cromolyn sodium 5.2 mg

Purpose

Nasal allergy symptom controller


Medication Information

Purpose

Nasal allergy symptom controller

Description

Cromolyn sodium 5.2 mg

Uses

to prevent and relieve nasal symptoms of hay fever and other nasal allergies:

  • runny/itchy nose
  • sneezing
  • allergic stuffy nose
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.
Do Not Use
  • if you are allergic to any of the ingredients
Questions?

call toll free 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.

CVS Quality MONEY BACK GURANTEE

Distributed by:

CVS Pharmacy Inc.,

Woonsocket, RI 02895

©2005 CVS/pharmacy

*This product is not manufactured or distributed by Pharmacia & Upjohn Company, owner of the registered trademark NasalCrom®.

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

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.

Active Ingredient (per Spray)

Cromolyn sodium 5.2 mg

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • fever
  • discolored nasal discharge
  • sinus pain
  • wheezing
Package/label Principal Display Panel

CVS pharmacy®

Compare to the active ingredient in Nasalcrom®

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

CVS PHARAMACIST RECOMMENDED

200 Metered Sprays

Each spray delivers

5.2 mg cromolyn sodium

0.88 FL OZ (26 mL)


Structured Label Content

Uses

to prevent and relieve nasal symptoms of hay fever and other nasal allergies:

  • runny/itchy nose
  • sneezing
  • allergic stuffy nose
Purpose

Nasal allergy symptom controller

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.
Do Not Use (Do not use)
  • if you are allergic to any of the ingredients
Questions?

call toll free 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.

CVS Quality MONEY BACK GURANTEE

Distributed by:

CVS Pharmacy Inc.,

Woonsocket, RI 02895

©2005 CVS/pharmacy

*This product is not manufactured or distributed by Pharmacia & Upjohn Company, owner of the registered trademark NasalCrom®.

Other Information (Other information)
  • store between 20°– 25°C (68°– 77°F)
  • protect from light
  • keep carton and package insert. They contain important instructions.
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, edetate disodium, purified water

When Using This Product (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 (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.

Active Ingredient (per Spray) (Active ingredient (per spray))

Cromolyn sodium 5.2 mg

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • discolored nasal discharge
  • sinus pain
  • wheezing
Package/label Principal Display Panel (Package/Label Principal Display Panel)

CVS pharmacy®

Compare to the active ingredient in Nasalcrom®

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

CVS PHARAMACIST RECOMMENDED

200 Metered Sprays

Each spray delivers

5.2 mg cromolyn sodium

0.88 FL OZ (26 mL)


Advanced Ingredient Data


Raw Label Data

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