Cromolyn Sodium Nasal Solution, USP NASAL SPRAY

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Full prescribing information#

SPL UNCLASSIFIED SECTION

 

(Adults and children 2 years and older)

Active ingredient (per spray)

OTC - ACTIVE INGREDIENT SECTION

Cromolyn sodium 5.2 mg

Purpose

OTC - PURPOSE SECTION

Nasal allergy symptom controller

Uses

INDICATIONS & USAGE SECTION

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

• runny/itchy nose
• sneezing
• allergic stuffy nose

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• if you are allergic to any of the ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• fever
• discolored nasal discharge
• sinus pain
• wheezing

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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 INGREDIENT SECTION

benzalkonium chloride, edetate disodium, purified water

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-323-0000

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)

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

• Cromolyn Sodium
• CROMOLYN
• BENZALKONIUM CHLORIDE
• EDETATE DISODIUM
• WATER

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Ingredients#

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