NasalCrom CROMOLYN SODIUM PRESTIGE BRANDS HOLDINGS, INC. 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

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (per spray) Cromolyn sodium 5.2mg
Inactive Ingredients
Inactive ingredients benzalkonium chloride edetate disodium purified water
Strengths
5.2 mg
Quantities
13 ml 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 UNKNOWN
UNII
Q2WXR1I0PK
Packaging

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) Principal Display Panel NASAL SPRAY NasalCrom ® cromolyn sodium nasal solution, USP NASAL 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)

Package Descriptions
  • 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) Principal Display Panel NASAL SPRAY NasalCrom ® cromolyn sodium nasal solution, USP NASAL 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)

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


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