CROMOLYN SODIUM

INDICATIONS AND USAGE Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 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.

DOSAGE AND ADMINISTRATION: NOT FOR INHALATION OR INJECTION. SEE DIRECTIONS FOR USE. The usual starting dose is as follows: Adults and Adolescents (13 Years and Older): Two ampules four times daily, taken one-half hour before meals and at bedtime. Children 2 to 12 Years: One ampule four times daily, taken one-half hour before meals and at bedtime. Pediatric Patients Under 2 Years: Not recommended. If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day. Patients should be advised that the effect of Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL therapy is dependent upon its administration at regular intervals, as directed. Maintenance Dose: Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained. Administration: Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL should be administered as a solution at least 1⁄2 hour before meals and at bedtime after preparation according to the following directions: 1. Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. 2. Stir solution. 3. Drink all of the liquid.

CONTRAINDICATIONS Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.

ADVERSE REACTIONS Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded. T o report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Other Adverse Events: Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience. In most cases the available information is incomplete and attribution to the drug cannot be determined. The majority of these reports involve the gastrointestinal system and include: diarrhea, nausea, abdominal pain, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, esophagospasm. Other less commonly reported events (the majority representing only a single report) include the following: Skin: pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity Musculoskeletal: arthralgia, myalgia, stiffness/weakness of legs Neurologic: headache, dizziness, hypoesthesia, paresthesia, migraine, convulsions, flushing Psychiatric: psychosis, anxiety, depression, hallucinations, behavior change, insomnia, nervousness Heart Rate: tachycardia, premature ventricular contractions (PVCs), palpitations Respiratory: pharyngitis, dyspnea Miscellaneous: fatigue, edema, unpleasant taste, chest pain, postprandial lightheadedness and lethargy, dysuria, urinary frequency, purpura, hepatic function test abnormal, polycythemia, neutropenia, pancytopenia, tinnitus, lupus erythematosus (LE) syndrome

DESCRIPTION Each 5 mL ampule of Cromolyn Sodium Oral Solution (Concentrate) contains 100 mg cromolyn sodium, USP, in Water for Injection. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The molecular formula is C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Its chemical structure is: Pharmacologic Category: Mast cell stabilizer Therapeutic Category: Antiallergic str-a

HOW SUPPLIED Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL is supplied in a BFS (Blow Fill Seal) ampules as follows: 5 mL fill in 5 mL BFS ampule, with 8 ampules per foil pouch and such 12 pouches in one outer carton. 5 mL fill in 5 mL BFS Ampule NDC 42571-132-21 Pouch of 8 x 5 mL BFS Ampules NDC 42571-132-95 Outer Carton of 96 x 5 mL (12 pouches of 8 x 5 mL BFS Ampules) NDC 42571-132-52 Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL should be stored between 15° to 30°C (59° to 86°F) and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children. Store ampules in foil pouch until ready for use. Manufactured by: Micro Labs Limited Bangalore-560 099, INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev. 11/2023