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
Drug Label Information
Updated June 1, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient (per spray)
- Purpose
- Uses
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Warnings
For external use only
When using this product
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- it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks.
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- brief stinging or sneezing may occur right after use
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- do not use it to treat sinus infection, asthma, or cold symptoms
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- do not share this bottle with anyone else as this may spread germs
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Directions
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- see package insert on how to use pump
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- parent or care provider must supervise the use of this product by young children
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adults and children 2 years and older:
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- 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.
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- use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust)
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- 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.
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- if desired, you can use this product with other medicines, including other allergy medicines.
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- children under 2 years: Do not use unless directed by a doctor.
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
HealthGuard
NDC 57782-397-26
Cromolyn
Sodium Nasal
Solution, USPNASAL SPRAY
Nasal Allergy Symptom Controller
For intranasal use only.Prevents and Relieves
Nasal Allergy Symptoms:- •
- runny/itchy nose
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- sneezing
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- 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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INGREDIENTS AND APPEARANCE
CROMOLYN SODIUM
cromolyn sodium spray, meteredProduct 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 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 1 200 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 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 Health Companies, Inc. 245141858 MANUFACTURE(57782-397)
