FDA label 178e3342-2eeb-441a-9ab9-e47d8e3c4dd1

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.

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) 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. To report SUSPECTED ADVERSE REACTIONS, contact Ailex Pharmaceuticals, LLC at 1-888-514-4727 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

<table width="75%"><col align="left"/><col align="left"/><tbody><tr styleCode="toprule"><td valign="top">Skin:</td><td>pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity</td></tr><tr><td valign="top">Musculoskeletal:</td><td>arthralgia, myalgia, stiffness/weakness of legs</td></tr><tr><td valign="top">Neurologic:</td><td>headache, dizziness, hypoesthesia, paresthesia, migraine, convulsions, flushing</td></tr><tr><td valign="top">Psychiatric:</td><td>psychosis, anxiety, depression, hallucinations, behavior change, insomnia, nervousness</td></tr><tr><td valign="top">Heart Rate:</td><td>tachycardia, premature ventricular contractions (PVCs), palpitations</td></tr><tr><td valign="top">Respiratory:</td><td>pharyngitis, dyspnea</td></tr><tr styleCode="botrule"><td valign="top">Miscellaneous:</td><td>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</td></tr></tbody></table>