Children 2-12 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 GASTROCROM 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
GASTROCROM should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions:

Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water.
Stir solution.
Drink all of the liquid.

HOW SUPPLIED
GASTROCROM Oral Concentrate is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch. Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water.

       NDC 18860-678-70     96 ampules x 5 mL

GASTROCROM Oral Concentrate should be stored between 15°-30°C (59°-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.

Marketed by:

Azur Pharma, Inc.
1818 Market Street, Suite 2350

Philadelphia, PA 19103, USA

Manufactured by:
Catalent Pharma Solutions
Woodstock, IL 60098 USA

Gastrocrom® is a registered trademark of
Azur Pharma International Limited©.

© 2010 Azur Pharma International Limited.

Rev. 05/10

GASMp-10-01

PHARMACIST – DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INSTRUCTIONS

Gastrocrom®(cromolyn sodium, USP) Oral Concentrate

For Oral Use Only – Not for Inhalation or Injection.

How to Use GASTROCROM: As with all prescription drugs, follow the directions for dosage that your physician recommends.

The effect of GASTROCROM therapy is dependent upon its administration at REGULAR intervals, for as long as recommended by your physician.

Usual Starting Dose:
Adults and Adolescents (13 Years and Older):
Two ampules four times daily, taken one-half hour before meals and at bedtime.

Children 2-12 Years:
One ampule four times daily, taken one-half hour before meals and at bedtime.

Note: Your physician may decide to increase OR decrease your dosage to achieve optimum results with GASTROCROM. However, do not change your dose or stop taking GASTROCROM without first consulting your physician.

Care & Storage: GASTROCROM Oral Concentrate should be stored between 15°-30°C (59°-86°F) and protected from light. Do not use if it contains a precipitate (particles or cloudiness) or becomes discolored. Keep out of the reach of children.

Store ampules in foil pouch until ready for use.

Recycling Information: GASTROCROM Oral Concentrate ampules are made with a low density polyethylene p