Cromolyn Sodium Nasal Solution, Usp

Cromolyn Sodium Nasal Solution, Usp
SPL v8
SPL
SPL Set ID 379f4b59-6866-4b5c-9b1b-d8a35b741461
Route
NASAL
Published
Effective Date 2021-06-01
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

  ( Adults and children 2 years and older )

Purpose

Nasal allergy symptom controller


Medication Information

Purpose

Nasal allergy symptom controller

Description

  ( Adults and children 2 years and older )

Uses

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

  • runny/itchy nose
  • sneezing
  • allergic stuffy nose
Section 42229-5

 

(Adults and children 2 years and older)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Warnings

For external use only

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
Other Information
  • store between 20-25°C (68-77°F)
  • protect from light
  • keep carton and package insert. They contain important instructions.
  • see bottom panel for lot number and expiration date
Inactive Ingredients

benzalkonium chloride, edetate disodium, purified water

Questions Or Comments?

Call toll-free 1-800-323-0000

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
Active Ingredient (per Spray)

Cromolyn sodium 5.2 mg

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

HealthGuard

NDC 57782-397-26

Cromolyn

Sodium Nasal

Solution, USP

NASAL SPRAY

Nasal Allergy Symptom Controller

For intranasal use only.

Prevents and Relieves

Nasal Allergy Symptoms:

  • runny/itchy nose
  • sneezing
  • allergic stuffy nose

Original Prescription Strength

Safe For Ages 2+

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
Section 42229-5 (42229-5)

 

(Adults and children 2 years and older)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Purpose

Nasal allergy symptom controller

Warnings

For external use only

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
Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • protect from light
  • keep carton and package insert. They contain important instructions.
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, edetate disodium, purified water

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-323-0000

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

Cromolyn sodium 5.2 mg

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)

HealthGuard

NDC 57782-397-26

Cromolyn

Sodium Nasal

Solution, USP

NASAL SPRAY

Nasal Allergy Symptom Controller

For intranasal use only.

Prevents and Relieves

Nasal Allergy Symptoms:

  • runny/itchy nose
  • sneezing
  • allergic stuffy nose

Original Prescription Strength

Safe For Ages 2+

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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