nasalcrom

nasalcrom
SPL v13
SPL
SPL Set ID b34d36ca-4df4-458c-af0f-c0d0c9a025d9
Route
nasal
Published
Effective Date 2025-10-30
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 2009-10-29 Until 2021-06-30

Purpose

Nasal allergy symptom controller

Description

NasalCrom Drug Facts


Medication Information

Warnings

For external use only

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.
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

Description

NasalCrom Drug Facts

Principal Display Panel

NASAL SPRAY

NasalCrom   ®

cromolyn sodium nasal solution , USP

N ASAL ALLERGY SYMPTOM CONTROLLER

Original Prescription Strength

Safe for ages 2+

100 Metered Sprays / Each spray delivers 5.2 mg cromolyn sodium

0.44 FL OZ (13 mL)

200 Metered Sprays / Each spray delivers 5.2 mg cromolyn sodium

0.88 FL OZ (26 mL)

Section 42229-5

NasalCrom

Drug Facts

Do Not Use

if you are allergic to any of the ingredients

Questions Or Comments?

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

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 5.2mg

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have
  • fever

  • discolored nasal discharge

  • sinus pain

  • wheezing

Structured Label Content

Warnings

For external use only

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.
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

Principal Display Panel

NASAL SPRAY

NasalCrom   ®

cromolyn sodium nasal solution , USP

N ASAL ALLERGY SYMPTOM CONTROLLER

Original Prescription Strength

Safe for ages 2+

100 Metered Sprays / Each spray delivers 5.2 mg cromolyn sodium

0.44 FL OZ (13 mL)

200 Metered Sprays / Each spray delivers 5.2 mg cromolyn sodium

0.88 FL OZ (26 mL)

Section 42229-5 (42229-5)

NasalCrom

Drug Facts

Do Not Use (Do not use)

if you are allergic to any of the ingredients

Questions Or Comments? (Questions or comments?)

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

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 5.2mg

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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

Advanced Ingredient Data


Raw Label Data

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