Label: CROMOLYN SODIUM spray, metered
- NDC Code(s): 57782-397-26
- Packager: Bausch & Lomb Incorporated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 19, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient (per spray)
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
- 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
- Inactive ingredients
Package/Label Principal Display Panel
Cromolyn Sodium Nasal Solution USP
Nasal Allergy Symptom Controller
Prevents and Relieves Nasal Allergy Symptoms:
allergic stuffy nose
Full Prescription Strength
Safe For Ages 2 Years & Older
200 Metered Sprays
Each spray delivers 5.2 mg cromolyn sodium
0.88 FL OZ (26 mL)
INGREDIENTS AND APPEARANCE
cromolyn sodium spray, metered
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57782-397 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM 5.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57782-397-26 1 in 1 CARTON 07/03/2001 1 26 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075702 07/03/2001 Labeler - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 079587625 MANUFACTURE(57782-397) Establishment Name Address ID/FEI Business Operations Cambrex Profarmaco Milano Srl 438051401 API MANUFACTURE(57782-397) Establishment Name Address ID/FEI Business Operations Aventis Pharma Manufacturing Pte LTD. 595299306 API MANUFACTURE(57782-397)