cromolyn sodium

FDA Drug Profile — NasalCrom, Gastrocrom, cromolyn sodium

Drug Details

Generic Name
cromolyn sodium
Brand Names
NasalCrom, Gastrocrom, cromolyn sodium
Application Number
ANDA075702
Sponsor
Prestige Brands Holdings, Inc.
NDC Codes
4
Dosage Forms
SPRAY, METERED, POWDER, LIQUID, SOLUTION
Routes
NASAL, ORAL
Active Ingredients
CROMOLYN SODIUM

Indications and Usage

INDICATIONS AND USAGE: Cromolyn Sodium Oral Solution, Concentrate is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.

Warnings

WARNINGS: The recommended dosage should be decreased in patients with decreased renal or hepatic function. Severe anaphylactic reactions may occur rarely in association with cromolyn sodium administration.