Cromolyn Sodium CROMOLYN SODIUM BAUSCH & LOMB INCORPORATED FDA Approved Uses to prevent and relieve nasal symptoms of hay fever and other nasal allergies: • runny/itchy nose • sneezing • allergic stuffy nose
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Substance Cromolyn Sodium
Route
NASAL
Applications
ANDA075702
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (per spray) Cromolyn sodium 5.2 mg
Inactive Ingredients
Inactive ingredients benzalkonium chloride edetate disodium purified water
Strengths
5.2 mg
Quantities
26 ml
Treats Conditions
Uses To Prevent And Relieve Nasal Symptoms Of Hay Fever And Other Nasal Allergies Runny Itchy Nose Sneezing Allergic Stuffy Nose

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
Q2WXR1I0PK
Packaging

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) carton

Package Descriptions
  • 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) carton

Overview

Uses to prevent and relieve nasal symptoms of hay fever and other nasal allergies: • runny/itchy nose • sneezing • allergic stuffy nose

Indications & Usage

Uses to prevent and relieve nasal symptoms of hay fever and other nasal allergies: • runny/itchy nose • sneezing • allergic stuffy nose

Dosage & Administration

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.

Warnings & Precautions
Warnings For external use only 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 (1-800-222-1222) right away.
Purpose

Purpose Nasal allergy symptom controller

Do Not Use

Do not use • if you are allergic to any of the ingredients

When Using

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 & Ask a Doctor

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

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.

Questions

Questions or comments? Call toll-free 1-800-323-0000


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