Label: NASALCROM- cromolyn sodium spray, metered
- NDC Code(s): 52183-199-13, 52183-199-14
- Packager: Prestige Brands Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 16, 2022
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- Drug Facts
- Active ingredient (per spray)
For external use only
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
- Questions or comments?
Principal Display Panel
cromolyn sodium nasal solution, USP
For Intranasal use only.
- runny / itchy nose
- allergic stuffy nose
ORIGINAL PRESCRIPTION STRENGTH
Safe for ages 2+
200 METERED SPRAYS
Each spray delivers 5.2 mg cromolyn sodium
INGREDIENTS AND APPEARANCE
cromolyn sodium spray, metered
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-199 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 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:52183-199-14 1 in 1 CARTON 10/29/2009 1 100 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:52183-199-13 1 in 1 CARTON 10/29/2009 2 200 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075702 10/29/2009 Labeler - Prestige Brands Holdings, Inc. (159655021) Establishment Name Address ID/FEI Business Operations Bausch Health Companies Inc. 245141858 MANUFACTURE(52183-199)